Source Subset Code Subset Name Concept Code Source PT Source Definition Source Synonym(s) FDA C54599 Limitation Of Use Structured Product Labeling Terminology C41332 Adverse Reaction FDA C54599 Limitation Of Use Structured Product Labeling Terminology C16352 African American FDA C54599 Limitation Of Use Structured Product Labeling Terminology C41259 American Indian or Alaska Native FDA C54599 Limitation Of Use Structured Product Labeling Terminology C41260 Asian FDA C54599 Limitation Of Use Structured Product Labeling Terminology C60654 Conditional Approval FDA C54599 Limitation Of Use Structured Product Labeling Terminology C50646 Contraindication Any special symptom or circumstance that renders the use of a remedy or the carrying out of a procedure inadvisable, usually because of the risk. FDA C54599 Limitation Of Use Structured Product Labeling Terminology C54346 Dose Modification FDA C54599 Limitation Of Use Structured Product Labeling Terminology C60655 Duration Of Use FDA C54599 Limitation Of Use Structured Product Labeling Terminology C16576 Female FDA C54599 Limitation Of Use Structured Product Labeling Terminology C54708 Interaction FDA C54599 Limitation Of Use Structured Product Labeling Terminology C54344 Limitation Of Use FDA C54599 Limitation Of Use Structured Product Labeling Terminology C54352 Limited Or No Information FDA C54599 Limitation Of Use Structured Product Labeling Terminology C20197 Male FDA C54599 Limitation Of Use Structured Product Labeling Terminology C41219 Native Hawaiian or Other Pacific Islander FDA C54599 Limitation Of Use Structured Product Labeling Terminology C17049 Race FDA C54599 Limitation Of Use Structured Product Labeling Terminology C54350 Second Line Treatment FDA C54599 Limitation Of Use Structured Product Labeling Terminology C28421 Sex FDA C54599 Limitation Of Use Structured Product Labeling Terminology C54351 Use With Caution FDA C54599 Limitation Of Use Structured Product Labeling Terminology C41261 White FDA C54600 Pharmacokinetic Effect Consequences Structured Product Labeling Terminology C54356 Decrease Drug Level FDA C54600 Pharmacokinetic Effect Consequences Structured Product Labeling Terminology C54614 Decreased Concomitant Drug AUC FDA C54600 Pharmacokinetic Effect Consequences Structured Product Labeling Terminology C54615 Decreased Concomitant Drug Cmax FDA C54600 Pharmacokinetic Effect Consequences Structured Product Labeling Terminology C54616 Decreased Concomitant Drug Half Life FDA C54600 Pharmacokinetic Effect Consequences Structured Product Labeling Terminology C54358 Decreased Concomitant Drug Level FDA C54600 Pharmacokinetic Effect Consequences Structured Product Labeling Terminology C54617 Decreased Concomitant Drug Tmax FDA C54600 Pharmacokinetic Effect Consequences Structured Product Labeling Terminology C54609 Decreased Drug AUC FDA C54600 Pharmacokinetic Effect Consequences Structured Product Labeling Terminology C54606 Decreased Drug Cmax FDA C54600 Pharmacokinetic Effect Consequences Structured Product Labeling Terminology C54607 Decreased Drug Half Life FDA C54600 Pharmacokinetic Effect Consequences Structured Product Labeling Terminology C54608 Decreased Drug Tmax FDA C54600 Pharmacokinetic Effect Consequences Structured Product Labeling Terminology C54357 Increase Concomitant Drug Level FDA C54600 Pharmacokinetic Effect Consequences Structured Product Labeling Terminology C54613 Increased Concomitant Drug AUC FDA C54600 Pharmacokinetic Effect Consequences Structured Product Labeling Terminology C54610 Increased Concomitant Drug Cmax FDA C54600 Pharmacokinetic Effect Consequences Structured Product Labeling Terminology C54611 Increased Concomitant Drug Half Life FDA C54600 Pharmacokinetic Effect Consequences Structured Product Labeling Terminology C54612 Increased Concomitant Drug Tmax FDA C54600 Pharmacokinetic Effect Consequences Structured Product Labeling Terminology C54605 Increased Drug AUC FDA C54600 Pharmacokinetic Effect Consequences Structured Product Labeling Terminology C54602 Increased Drug Cmax FDA C54600 Pharmacokinetic Effect Consequences Structured Product Labeling Terminology C54603 Increased Drug Half Life FDA C54600 Pharmacokinetic Effect Consequences Structured Product Labeling Terminology C54355 Increased Drug Level FDA C54600 Pharmacokinetic Effect Consequences Structured Product Labeling Terminology C54604 Increased Drug Tmax FDA C54600 Pharmacokinetic Effect Consequences Structured Product Labeling Terminology C54354 Pharmacokinetic Effect Consequences FDA C73600 Structured Product Labeling Business Operation Terminology C71586 EXPORT FDA C73600 Structured Product Labeling Business Operation Terminology C73599 IMPORT FDA C73600 Structured Product Labeling Business Operation Terminology C43360 MANUFACTURE FDA C73600 Structured Product Labeling Business Operation Terminology C73608 PRIVATE LABEL DISTRIBUTION FDA C73600 Structured Product Labeling Business Operation Terminology C73607 RELABEL FDA C73600 Structured Product Labeling Business Operation Terminology C73606 REPACK FDA C54453 Structured Product Labeling Color Terminology C48323 BLACK rgb(0, 0, 0) FDA C54453 Structured Product Labeling Color Terminology C48333 BLUE rgb(0, 0, 255) FDA C54453 Structured Product Labeling Color Terminology C48332 BROWN rgb(165, 42, 42) FDA C54453 Structured Product Labeling Color Terminology C48324 GRAY rgb(128, 128, 128) FDA C54453 Structured Product Labeling Color Terminology C48329 GREEN rgb(0, 128, 0) FDA C54453 Structured Product Labeling Color Terminology C48331 ORANGE rgb(255, 165, 0) FDA C54453 Structured Product Labeling Color Terminology C48328 PINK rgb(255, 192, 203) FDA C54453 Structured Product Labeling Color Terminology C48327 PURPLE rgb(128, 0, 128) FDA C54453 Structured Product Labeling Color Terminology C48326 RED rgb(255, 0, 0) FDA C54453 Structured Product Labeling Color Terminology C48556 SPL COLOR FDA C54453 Structured Product Labeling Color Terminology C48334 TURQOUISE rgb(64, 224, 208) FDA C54453 Structured Product Labeling Color Terminology C48325 WHITE rgb(255, 255, 255) FDA C54453 Structured Product Labeling Color Terminology C48330 YELLOW rgb(255, 255, 0) FDA C54459 Structured Product Labeling DEA Schedule Terminology C48672 CI Schedule I. FDA C54459 Structured Product Labeling DEA Schedule Terminology C48675 CII Schedule II. FDA C54459 Structured Product Labeling DEA Schedule Terminology C48676 CIII Schedule III. FDA C54459 Structured Product Labeling DEA Schedule Terminology C48677 CIV Schedule IV. FDA C54459 Structured Product Labeling DEA Schedule Terminology C48679 CV Schedule V. FDA C54459 Structured Product Labeling DEA Schedule Terminology C48670 SPL DEA Schedule The abuse potential category to which an active ingredient, or combination of active ingredients, is assigned, as regulated by both the United States Drug Enforcement Administration (DEA) and the United States Food and Drug Administration. FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38192 AURICULAR (OTIC) Administration to or by way of the ear. OTIC FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38193 BUCCAL Administration directed toward the cheek, generally from within the mouth. FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38194 CONJUNCTIVAL Administration to the conjunctiva, the delicate membrane that lines the eyelids and covers the exposed surface of the eyeball. CONJUNC FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38675 CUTANEOUS Administration to the skin. CUTAN FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38197 DENTAL Administration to a tooth or teeth. DENTAL FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38633 ELECTRO-OSMOSIS Administration of through the diffusion of substance through a membrane in an electric field. EL-OSMOS FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38205 ENDOCERVICAL Administration within the canal of the cervix uteri. Synonymous with the term intracervical. E-CERVIC FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38206 ENDOSINUSIAL Administration within the nasal sinuses of the head. E-SINUS FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38208 ENDOTRACHEAL Administration directly into the trachea. Synonymous with the term intratracheal. E-TRACHE FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38209 ENTERAL Administration directly into the intestines. ENTER FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38210 EPIDURAL Administration upon or over the dura mater. EPIDUR FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38211 EXTRA-AMNIOTIC Administration to the outside of the membrane enveloping the fetus. X-AMNI FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38212 EXTRACORPOREAL Administration outside of the body. X-CORPOR FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38200 HEMODIALYSIS Administration through hemodialysate fluid. HEMO FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38215 INFILTRATION Administration that results in substances passing into tissue spaces or into cells. INFIL FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38219 INTERSTITIAL Administration to or in the interstices of a tissue. INTERSTIT FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38220 INTRA-ABDOMINAL Administration within the abdomen. I-ABDOM FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38221 INTRA-AMNIOTIC Administration within the amnion. I-AMNI FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38222 INTRA-ARTERIAL Administration within an artery or arteries. I-ARTER FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38223 INTRA-ARTICULAR Administration within a joint. I-ARTIC FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38224 INTRABILIARY Administration within the bile, bile ducts or gallbladder. I-BILI FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38225 INTRABRONCHIAL Administration within a bronchus. I-BRONCHI FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38226 INTRABURSAL Administration within a bursa. I-BURSAL FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38227 INTRACARDIAC Administration within the heart. I-CARDI FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38228 INTRACARTILAGINOUS Administration within a cartilage; endochondral. I-CARTIL FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38229 INTRACAUDAL Administration within the cauda equina. I-CAUDAL FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38230 INTRACAVERNOUS Administration within a pathologic cavity, such as occurs in the lung in tuberculosis. I-CAVERN FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38231 INTRACAVITARY Administration within a non-pathologic cavity, such as that of the cervix, uterus, or penis, or such as that is formed as the result of a wound. I-CAVIT FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38232 INTRACEREBRAL Administration within the cerebrum. I-CERE FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38233 INTRACISTERNAL Administration within the cisterna magna cerebellomedularis. I-CISTERN FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38234 INTRACORNEAL Administration within the cornea (the transparent structure forming the anterior part of the fibrous tunic of the eye). I-CORNE FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38217 INTRACORONAL, DENTAL Administration of a drug within a portion of a tooth which is covered by enamel and which is separated from the roots by a slightly constricted region known as the neck. I-CORONAL FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38218 INTRACORONARY Administration within the coronary arteries. I-CORONARY FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38235 INTRACORPORUS CAVERNOSUM Administration within the dilatable spaces of the corporus cavernosa of the penis. I-CORPOR FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38238 INTRADERMAL Administration within the dermis. I-DERMAL FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38239 INTRADISCAL Administration within a disc. I-DISCAL FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38240 INTRADUCTAL Administration within the duct of a gland. I-DUCTAL FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38241 INTRADUODENAL Administration within the duodenum. I-DUOD FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38242 INTRADURAL Administration within or beneath the dura. I-DURAL FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38243 INTRAEPIDERMAL I-EPIDERM FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38245 INTRAESOPHAGEAL Administration within the esophagus. I-ESO FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38246 INTRAGASTRIC Administration within the stomach. I-GASTRIC FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38247 INTRAGINGIVAL Administration within the gingivae. I-GINGIV FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38249 INTRAILEAL Administration within the distal portion of the small intestine, from the jejunum to the cecum. I-ILE FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38250 INTRALESIONAL Administration within or introduced directly into a localized lesion. I-LESION FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38251 INTRALUMINAL Administration within the lumen of a tube. I-LUMIN FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38252 INTRALYMPHATIC Administration within the lymph. I-LYMPHAT FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38253 INTRAMEDULLARY Administration within the marrow cavity of a bone. I-MEDUL FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38254 INTRAMENINGEAL Administration within the meninges (the three membranes that envelope the brain and spinal cord). I-MENIN FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C28161 INTRAMUSCULAR Administration within a muscle. IM FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38255 INTRAOCULAR Administration within the eye. I-OCUL FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38256 INTRAOVARIAN Administration within the ovary. I-OVAR FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38257 INTRAPERICARDIAL Administration within the pericardium. I-PERICARD FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38258 INTRAPERITONEAL Administration within the peritoneal cavity. I-PERITON FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38259 INTRAPLEURAL Administration within the pleura. I-PLEURAL FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38260 INTRAPROSTATIC Administration within the prostate gland. I-PROSTAT FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38261 INTRAPULMONARY Administration within the lungs or its bronchi. I-PULMON FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38262 INTRASINAL Administration within the nasal or periorbital sinuses. I-SINAL FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38263 INTRASPINAL Administration within the vertebral column. I-SPINAL FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38264 INTRASYNOVIAL Administration within the synovial cavity of a joint. I-SYNOV FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38265 INTRATENDINOUS Administration within a tendon. I-TENDIN FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38266 INTRATESTICULAR Administration within the testicle. I-TESTIC FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38267 INTRATHECAL Administration within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles. IT FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38207 INTRATHORACIC Administration within the thorax (internal to the ribs); synonymous with the term endothoracic. I-THORAC FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38268 INTRATUBULAR Administration within the tubules of an organ. I-TUBUL FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38269 INTRATUMOR Administration within a tumor. I-TUMOR FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38270 INTRATYMPANIC Administration within the auris media. I-TYMPAN FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38272 INTRAUTERINE Administration within the uterus. I-UTER FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38273 INTRAVASCULAR Administration within a vessel or vessels. I-VASC FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38276 INTRAVENOUS Administration within or into a vein or veins. IV FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38274 INTRAVENOUS BOLUS Administration within or into a vein or veins all at once. IV BOLUS FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38279 INTRAVENOUS DRIP Administration within or into a vein or veins over a sustained period of time. IV DRIP FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38277 INTRAVENTRICULAR Administration within a ventricle. I-VENTRIC FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38278 INTRAVESICAL Administration within the bladder. I-VESIC FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38280 INTRAVITREAL Administration within the vitreous body of the eye. I-VITRE FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38203 IONTOPHORESIS Administration by means of an electric current where ions of soluble salts migrate into the tissues of the body. ION FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38281 IRRIGATION Administration to bathe or flush open wounds or body cavities. IRRIG FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38282 LARYNGEAL Administration directly upon the larynx. LARYN FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38284 NASAL Administration to the nose; administered by way of the nose. NASAL FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38285 NASOGASTRIC Administration through the nose and into the stomach, usually by means of a tube. NG FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C48623 NOT APPLICABLE Routes of administration are not applicable. NA FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38286 OCCLUSIVE DRESSING TECHNIQUE Administration by the topical route which is then covered by a dressing which occludes the area. OCCLUS FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38287 OPHTHALMIC Administration to the external eye. OPHTHALM FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38288 ORAL Administration to or by way of the mouth. FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38289 OROPHARYNGEAL Administration directly to the mouth and pharynx. ORO FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38290 OTHER Administration is different from others on this list. FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38291 PARENTERAL Administration by injection, infusion, or implantation. PAREN FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38676 PERCUTANEOUS Administration through the skin. PERCUT FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38292 PERIARTICULAR Administration around a joint. P-ARTIC FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38677 PERIDURAL Administration to the outside of the dura mater of the spinal cord. P-DURAL FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38293 PERINEURAL Administration surrounding a nerve or nerves. P-NEURAL FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38294 PERIODONTAL Administration around a tooth. P-ODONT FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38295 RECTAL Administration to the rectum. RECTAL FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38216 RESPIRATORY (INHALATION) Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect. RESPIR FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38296 RETROBULBAR Administration behind the pons or behind the eyeball. RETRO FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38114 ROUTE OF ADMINISTRATION FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38198 SOFT TISSUE Administration into any soft tissue. SOFT TIS FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38297 SUBARACHNOID Administration beneath the arachnoid. S-ARACH FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38298 SUBCONJUNCTIVAL Administration beneath the conjunctiva. S-CONJUNC FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38299 SUBCUTANEOUS Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL. SC FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38300 SUBLINGUAL Administration beneath the tongue. SL FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38301 SUBMUCOSAL Administration beneath the mucous membrane. S-MUCOS FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38304 TOPICAL Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL. TOPIC FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38305 TRANSDERMAL Administration through the dermal layer of the skin to the systemic circulation by diffusion. T-DERMAL FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38283 TRANSMUCOSAL Administration across the mucosa. T-MUCOS FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38307 TRANSPLACENTAL Administration through or across the placenta. T-PLACENT FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38308 TRANSTRACHEAL Administration through the wall of the trachea. T-TRACHE FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38309 TRANSTYMPANIC Administration across or through the tympanic cavity. T-TYMPAN FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38310 UNASSIGNED Route of administration has not yet been assigned. UNAS FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38311 UNKNOWN Route of administration is unknown. UNKNOWN FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38312 URETERAL Administration into the ureter. URETER FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38271 URETHRAL Administration into the urethra. URETH FDA C54455 Structured Product Labeling Drug Route of Administration Terminology C38313 VAGINAL Administration into the vagina. VAGIN FDA C73339 Structured Product Labeling Flavor Terminology C73360 ALMOND LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73361 ANISE LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73362 APPLE LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73363 APRICOT LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73364 BANANA LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73365 BERRY LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73366 BLACKBERRY LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73367 BLUEBERRY LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73368 BUBBLE GUM LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73369 BURGUNDY LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73370 BUTTER PECAN LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73371 BUTTERMINT LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73372 BUTTERSCOTCH LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73373 CARAMEL LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73374 CHEESE LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73375 CHERRY LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73376 CHOCOLATE LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73377 CINNAMON LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73378 CITRUS LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73379 COCONUT LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73380 COFFEE LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73381 COLA LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73382 COTTON CANDY LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73383 CRANBERRY LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73384 CREME DE MENTHE LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73385 CURACAO LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73386 CUSTARD LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73387 EGG NOG LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73388 FIG LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73389 FRUIT LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73390 FRUIT PUNCH LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73391 GRAPE LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73392 GRAPEFRUIT LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73393 GUARANA LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73394 HONEY LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73395 KIWI LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73396 LEMON LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73397 LICORICE LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73398 LIME LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73399 LIVER LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73400 MANGO LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73433 MAQUE TREE LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73402 MEAT LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73403 MENTHOL LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73404 MINT LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73405 ORANGE LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73406 ORANGE BANANA LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73407 PEACH LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73408 PEPPERMINT LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73409 PINEAPPLE LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73410 PLUM LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73411 POMEGRANATE LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73412 RAISIN LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73413 RASPBERRY LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73414 ROOT BEER LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73415 RUM LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73416 SPEARMINT LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73338 SPLFLAVOR A characteristic of a dosage form of a medicinal product, specifying the most predominant flavor. SPLFLAVOR is not an FDA specification for the names of specific flavors that may appear as inactive ingredients in labeling FDA C73339 Structured Product Labeling Flavor Terminology C73417 STRAWBERRY LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73418 TANGERINE LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73419 TROPICAL FRUIT PUNCH LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73420 TUTTI FRUTTI LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73421 VANILLA LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73422 WALNUT LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73423 WATERMELON LITERAL FDA C73339 Structured Product Labeling Flavor Terminology C73424 WINTERGREEN LITERAL FDA C73582 Structured Product Labeling Marketing Category Terminology C73583 ANADA FDA C73582 Structured Product Labeling Marketing Category Terminology C73584 ANDA FDA C73582 Structured Product Labeling Marketing Category Terminology C73585 BLA FDA C73582 Structured Product Labeling Marketing Category Terminology C73586 BULK ACTIVE INGREDIENT FDA C73582 Structured Product Labeling Marketing Category Terminology C73587 BULK INACTIVE INGREDIENT FDA C73582 Structured Product Labeling Marketing Category Terminology C73626 BULK INGREDIENT FDA C73582 Structured Product Labeling Marketing Category Terminology C73588 CONDITIONAL NADA FDA C73582 Structured Product Labeling Marketing Category Terminology C73590 EXPORT ONLY FDA C73582 Structured Product Labeling Marketing Category Terminology C73593 NADA FDA C73582 Structured Product Labeling Marketing Category Terminology C73594 NDA FDA C73582 Structured Product Labeling Marketing Category Terminology C73605 NDA AUTHORIZED GENERIC FDA C73582 Structured Product Labeling Marketing Category Terminology C73603 OTC MONOGRAPH FINAL Product marketed under a finalized OTC Monograph. FDA C73582 Structured Product Labeling Marketing Category Terminology C73604 OTC MONOGRAPH NOT FINAL Product marketed under an OTC monograph not yet finalized. FDA C73582 Structured Product Labeling Marketing Category Terminology C73581 SPL MARKETING CATEGORY FDA C73582 Structured Product Labeling Marketing Category Terminology C73614 UNAPPROVED HOMEOPATHIC FDA C73582 Structured Product Labeling Marketing Category Terminology C73613 UNAPPROVED MEDICAL GAS FDA C73582 Structured Product Labeling Marketing Category Terminology C73627 UNAPPROVED OTHER FDA C73582 Structured Product Labeling Marketing Category Terminology C73615 UNAPPROVED VITAMIN DRUG FDA C54619 Structured Product Labeling Medical Product Intent Of Use Terminology C54415 Diagnostic For FDA C54619 Structured Product Labeling Medical Product Intent Of Use Terminology C54390 Medical Product Intent Of Use FDA C54619 Structured Product Labeling Medical Product Intent Of Use Terminology C54416 Mitigation FDA C54619 Structured Product Labeling Medical Product Intent Of Use Terminology C54404 Prophylaxis For FDA C54619 Structured Product Labeling Medical Product Intent Of Use Terminology C54398 Treat FDA C54457 Structured Product Labeling Package Type Terminology C43165 AMPULE A container capable of being hermetically sealed, intended to hold sterile materials. AMP FDA C54457 Structured Product Labeling Package Type Terminology C43166 APPLICATOR A pre-filled non-injectable pipette, syringe or tube. AP FDA C54457 Structured Product Labeling Package Type Terminology C43167 BAG A sac or pouch. BAG FDA C54457 Structured Product Labeling Package Type Terminology C43168 BLISTER PACK A package that consists of molded plastic or laminate that has indentations (viewed as 'blisters' when flipped) into which a dosage form, is placed. A covering, usually of laminated material, is then sealed to the molded part. A strip pack is a specialized type of blister pack where there are no pre-formed or molded parts; in this case there are two flexible layers that are sealed with the dosage form in between. Suppositories that are strip packed between two layers of foil are also considered a blister pack. BLPK FDA C54457 Structured Product Labeling Package Type Terminology C43169 BOTTLE A vessel with a narrow neck designed to accept a specific closure. BOT FDA C54457 Structured Product Labeling Package Type Terminology C43170 BOTTLE, DISPENSING A bottle that is used by the pharmacist to dispense the prescribed medication. It includes preparations for which a dropper accompanies the bottle. BOTDIS FDA C54457 Structured Product Labeling Package Type Terminology C43171 BOTTLE, DROPPER A bottle that has a device specifically intended for the application of a liquid in a drop by drop manner, or a device intended for the delivery of an exact dose (e.g., calibrated dropper for oral medications). BOTDR FDA C54457 Structured Product Labeling Package Type Terminology C43172 BOTTLE, GLASS A glass vessel with a narrow neck designed to accept a specific closure. BOTGL FDA C54457 Structured Product Labeling Package Type Terminology C43173 BOTTLE, PLASTIC A plastic vessel with a narrow neck designed to accept a specific closure. BOTPL FDA C54457 Structured Product Labeling Package Type Terminology C43174 BOTTLE, PUMP A bottle that is fitted with a pumping mechanism for the administration of drug product. BOTPU FDA C54457 Structured Product Labeling Package Type Terminology C43175 BOTTLE, SPRAY A bottle that is fitted with an atomizer or a device which produces finely divided liquid carried by air. BOTSPR FDA C54457 Structured Product Labeling Package Type Terminology C43176 BOTTLE, UNIT-DOSE A bottle that contains a single whole dose of a non-parenteral drug product. BOTUD FDA C54457 Structured Product Labeling Package Type Terminology C43177 BOTTLE, WITH APPLICATOR A bottle which includes a device for applying its contents. BOTAP FDA C54457 Structured Product Labeling Package Type Terminology C43178 BOX A square or rectangular vessel, usually made of cardboard or plastic. FDA C54457 Structured Product Labeling Package Type Terminology C43179 BOX, UNIT-DOSE A box that contains a single dose of a non-parenteral drug product. [Note: Boxes that contain 100 unit dose blister packs should be classified under blister pack, since this is the immediate container into which the dosage form is placed.] BOXUD FDA C54457 Structured Product Labeling Package Type Terminology C43180 CAN A cylindrical vessel, usually made of metal. FDA C54457 Structured Product Labeling Package Type Terminology C43181 CANISTER A type of can for holding a drug product. CSTR FDA C54457 Structured Product Labeling Package Type Terminology C43182 CARTON A cardboard box or container which is usually considered a secondary packaging component. CRTN FDA C54457 Structured Product Labeling Package Type Terminology C43183 CARTRIDGE A container consisting of a cylinder with a septum at one end, and a seal at the other end, which is inserted into a device to form a syringe which contains a single dose of a parenteral drug product. CTG FDA C54457 Structured Product Labeling Package Type Terminology C43184 CASE A receptacle for holding something (e.g., that into which some oral contraceptive blister packs are placed). CASE FDA C54457 Structured Product Labeling Package Type Terminology C43185 CELLO PACK A plastic 'clamshell' [thin plastic pre-formed structure for a device]. CELLO FDA C54457 Structured Product Labeling Package Type Terminology C43186 CONTAINER A receptacle designed to hold a specific dosage form. CTR FDA C54457 Structured Product Labeling Package Type Terminology C43187 CUP A bowl-shaped container. CUP FDA C54457 Structured Product Labeling Package Type Terminology C43188 CUP, UNIT-DOSE A cup intended to hold a single dose of a non-parenteral drug product. CUPUD FDA C54457 Structured Product Labeling Package Type Terminology C43189 CYLINDER A container designed specifically to hold gases. CYL FDA C54457 Structured Product Labeling Package Type Terminology C43190 DEWAR A container, usually made of glass or metal, that has at least two walls with the space between each wall evacuated so as to prevent the transfer of heat. The inside of the container often has a coating (as silvering) on the inside to reduce heat transfer, and is used especially for storing liquified gases or for experiments at low temperatures. The size can vary from that of a small thermos bottle up to that which may be mounted upon a large truck (also known as a 'cryogenic truck'). DEW FDA C54457 Structured Product Labeling Package Type Terminology C43191 DIALPACK A dose pack container designed to assist with patient compliance. The patient turns a dial to the correct day and the correct dose is made available and the container indicates that the dose has been removed. DLPK FDA C54457 Structured Product Labeling Package Type Terminology C43192 DOSE PACK A container in which a preselected dose or dose regimen of the medication is placed. DSPK FDA C54457 Structured Product Labeling Package Type Terminology C43193 DRUM A straight-sided cylindrical shipping container with flat ends; one of which can be opened/closed. DRUM FDA C54457 Structured Product Labeling Package Type Terminology C16738 INHALER A device by means of which a medicinal product can be administered by inspiration through the nose or the mouth. INHL FDA C54457 Structured Product Labeling Package Type Terminology C43194 INHALER, REFILL A container of medication intended to refill an inhaler. INHLRE FDA C54457 Structured Product Labeling Package Type Terminology C43195 JAR A rigid container having a wide mouth and often no neck which typically holds solid or semisolid drug products. JAR FDA C54457 Structured Product Labeling Package Type Terminology C43196 JUG A large, deep container that has a narrow mouth, is typically fitted with a handle, and is used to hold liquids. JUG FDA C54457 Structured Product Labeling Package Type Terminology C43197 KIT A package which includes a container of drug product(s) and the equipment and supplies used with it. FDA C54457 Structured Product Labeling Package Type Terminology C48626 NOT STATED The package type is not stated or is unavailable. NS FDA C54457 Structured Product Labeling Package Type Terminology C43233 PACKAGE The drug product container with any accompanying materials or components. This may include the protective packaging, labeling, administration devices, etc. PKG FDA C54457 Structured Product Labeling Package Type Terminology C43164 PACKAGE TYPE FDA C54457 Structured Product Labeling Package Type Terminology C43198 PACKAGE, COMBINATION A package in which two or more drug products that are normally available separately are now available together. PKGCOM FDA C54457 Structured Product Labeling Package Type Terminology C43199 PACKET An envelope into which only one dose of a drug product, usually in the form of granules or powder, has been directly placed. An example includes glassine powder paper containing aspirin. Other examples include aluminum foil packets into which alcohol swabs and pledgets are placed. PKT FDA C54457 Structured Product Labeling Package Type Terminology C43200 POUCH A flexible container used to protect or hold one or more doses of a drug product (e.g. a pouch into which oral contraceptive blister packs are inserted, and an overwrap pouch for large volume parenterals). POU FDA C54457 Structured Product Labeling Package Type Terminology C43201 SUPERSACK A multilayer paper bag for shipping some solid bulk excipients, usually in the form of powder or granules. SUPSACK FDA C54457 Structured Product Labeling Package Type Terminology C43202 SYRINGE A device for the administration of parenteral drug products that consists of a rigid barrel fitted with septum with a plunger at one end and a seal or needle at the other end. The needle assembly may be part of the device or separate. SYR FDA C54457 Structured Product Labeling Package Type Terminology C43203 SYRINGE, GLASS A device for the administration of parenteral drug products that consists of a rigid glass barrel fitted with septum with a plunger at one end and a seal or needle at the other end. The needle assembly may be part of the device or separate. SYRGL FDA C54457 Structured Product Labeling Package Type Terminology C43204 SYRINGE, PLASTIC A device for the administration of parenteral drug products that consists of a rigid plastic barrel fitted with septum with a plunger at one end and a seal or needle at the other end. The needle assembly may be part of the device or separate. SYRPL FDA C54457 Structured Product Labeling Package Type Terminology C43205 TABMINDER A specialized package; it registers each time it is opened and is used for checking patient compliance to prescribed medication regimens. TABMIND FDA C54457 Structured Product Labeling Package Type Terminology C43206 TANK A large receptacle used for holding, transporting, or storing liquids or gases, and often referred to as a reservoir. FDA C54457 Structured Product Labeling Package Type Terminology C53438 TRAY A shallow flat receptacle, with a raised edge or rim,used for carrying, holding, or displaying finished drug product in its primary or market package. A tray and its contents may be encased in shrink-wrapped plastic for shipping, or with a cover or an overwrap as part of a unit of use package or kit. TRAY FDA C54457 Structured Product Labeling Package Type Terminology C42794 TUBE A flexible container for semisolid drug products which is flattened and crimped or sealed at one end and has a reclosable opening at the other. FDA C54457 Structured Product Labeling Package Type Terminology C43207 TUBE, WITH APPLICATOR A tube which is provided with a device (the applicator) for administering the dosage form. The applicator may be part of the tube closure or be separate. TUBEAP FDA C54457 Structured Product Labeling Package Type Terminology C43226 VIAL A container designed for use with parenteral drug products. VIAL FDA C54457 Structured Product Labeling Package Type Terminology C43208 VIAL, DISPENSING A vial that is used by the pharmacist to dispense the prescribed medication. VIALDIS FDA C54457 Structured Product Labeling Package Type Terminology C43209 VIAL, GLASS A glass container designed for use with parenteral drug products. VIALGL FDA C54457 Structured Product Labeling Package Type Terminology C43210 VIAL, MULTI-DOSE A vial intended to contain more than one dose of the drug product. VIALMD FDA C54457 Structured Product Labeling Package Type Terminology C43211 VIAL, PATENT DELIVERY SYSTEM A vial that has a patented delivery system. VIALPAT FDA C54457 Structured Product Labeling Package Type Terminology C43212 VIAL, PHARMACY BULK PACKAGE A container of a sterile preparation whose contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for infusion or, through a sterile transfer device, for the filling of empty sterile syringes. VIALPHR FDA C54457 Structured Product Labeling Package Type Terminology C43213 VIAL, PIGGYBACK A vial that contains a parenteral preparation that can be attached directly to the tubing of a parenterally administered fluid. VIALPIG FDA C54457 Structured Product Labeling Package Type Terminology C43214 VIAL, PLASTIC A plastic container designed for use with parenteral drug products. VIALPL FDA C54457 Structured Product Labeling Package Type Terminology C43215 VIAL, SINGLE-DOSE A vial containing a single unit of a parenteral drug product. VIALSD FDA C54457 Structured Product Labeling Package Type Terminology C43216 VIAL, SINGLE-USE A vial where a single dose of a parenteral drug product can be removed, and then the vial and its remaining contents can be disposed. VIALSU FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42887 AEROSOL A product that is packaged under pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols). AER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42888 AEROSOL, FOAM A dosage form containing one or more active ingredients, surfactants, aqueous or non-aqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged. AER FOAM FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42960 AEROSOL, METERED A pressurized dosage form consisting of metered dose valves which allow for the delivery of a uniform quantity of spray upon each activation. AER MET FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42971 AEROSOL, POWDER A product that is packaged under pressure and contains therapeutically active ingredients, in the form of a powder, that are released upon activation of an appropriate valve system. AER PWD FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42889 AEROSOL, SPRAY An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents. AER SPRAY FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42892 BAR, CHEWABLE A solid dosage form usually in the form of a rectangle that is meant to be chewed. BAR CHEW FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42890 BEAD A solid dosage form in the shape of a small ball. BEAD FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C43451 BEAD, IMPLANT, EXTENDED RELEASE A small sterile solid mass consisting of a highly purified drug intended for implantation in the body which would allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form. BEAD IMP ER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42891 BLOCK Solid dosage form, usually in the shape of a square or rectangle. BLOCK FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C25158 CAPSULE A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed. CAP FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42895 CAPSULE, COATED A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated coating. CAP COATED FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42896 CAPSULE, COATED PELLETS A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which varying amounts of coating have been applied. CAP COATED PELLETS FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42917 CAPSULE, COATED, EXTENDED RELEASE A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated coating, and which releases a drug (or drugs) in such a manner to allow at least a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. CAP COATED ER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42902 CAPSULE, DELAYED RELEASE A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms. CAP DR FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42904 CAPSULE, DELAYED RELEASE PELLETS A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which enteric coating has been applied, thus delaying release of the drug until its passage into the intestines. CAP DR PELLETS FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42916 CAPSULE, EXTENDED RELEASE A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. CAP ER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42928 CAPSULE, FILM COATED, EXTENDED RELEASE A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated film coating, and which releases a drug (or drugs) in such a manner to allow at least a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. CAP FILM COATED ER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42936 CAPSULE, GELATIN COATED A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal. CAP GELATIN COATED FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42954 CAPSULE, LIQUID FILLED A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle. CAP LIQ FILLED FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C45414 CEMENT A substance that serves to produce solid union between two surfaces. CEMENT FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42678 CIGARETTE A narrow tube filled with material that is capable to burn with release of therapeutically-active substance(s) during the process of smoking. Cigarette is a very efficient drug-delivery inhaler system for fast-acting substances. CIGARETTE FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C60884 CLOTH A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing. CLOTH FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C60891 CONCENTRATE A liquid preparation of increased strength and reduced volume which is usually diluted prior to administration. CONC FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42900 CONE A solid dosage form bounded by a circular base and the surface formed by line segments joining every point of the boundary of the base to a common vertex. A cone (usually containing antibiotics) is normally placed below the gingiva after a dental extraction. CONE FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42919 CORE, EXTENDED RELEASE An ocular system placed in the eye from which the drug diffuses through a membrane at a constant rate over a specified period. CORE ER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C28944 CREAM An emulsion, semisolid (1) dosage form, usually containing > 20% water and volatiles (2) and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: Percent water and volatiles are measured by a loss on drying test in which the sample is heated at 105 degrees C until constant weight is achieved. FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C60897 CREAM, AUGMENTED A cream dosage form that enhances drug delivery. Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered augmented. CREAM AUG FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42901 CRYSTAL A naturally produced angular solid of definite form in which the ultimate units from which it is built up are systematically arranged; they are usually evenly spaced on a regular space lattice. CRYSTAL FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C47890 DIAPHRAGM A device usually dome-shaped, worn during copulation over the cervical mouth for prevention of conception or infection. DIAPHRAM FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C43525 DISC A circular plate-like organ or structure. DISC FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42679 DOUCHE A liquid preparation, intended for the irrigative cleansing of the vagina, that is prepared from powders, liquid solutions, or liquid concentrates and contains one or more chemical substances dissolved in a suitable solvent or mutually miscible solvents. DOUCHE FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42763 DRESSING The application of various materials for protecting a wound. DRESSING FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C17423 DRUG DELIVERY SYSTEM Modern technology, distributed with or as a part of a drug product that allows for the uniform release or targeting of drugs to the body. DDS FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42912 ELIXIR A clear, pleasantly flavored, sweetened hydroalcoholic liquid containing dissolved medicinal agents; it is intended for oral use. ELIXIR FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42913 EMULSION A dosage form consisting of a two-phase system comprised of at least two immiscible liquids (1), one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. Note 1: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. Note 2: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment. EMULSION FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42915 ENEMA A rectal preparation for therapeutic, diagnostic, or nutritive purposes. FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42929 EXTRACT A concentrated preparation of vegetable or animal drugs obtained by removal of the active constituents of the respective drugs with a suitable menstrua, evaporation of all or nearly all of the solvent, and adjustment of the residual masses or powders to the prescribed standards. EXTRACT FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C60926 FIBER, EXTENDED RELEASE A slender and elongated solid thread-like substance that delivers drug in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. FIBER ER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42932 FILM A thin layer or coating. FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42920 FILM, EXTENDED RELEASE A drug delivery system in the form of a film that releases the drug over an extended period in such a way as to maintain constant drug levels in the blood or target tissue. FILM ER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42984 FILM, SOLUBLE A thin layer or coating which is susceptible to being dissolved when in contact with a liquid. FILM SOLUBLE FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C60927 FOR SOLUTION A product, usually a solid, intended for solution prior to administration. FOR SOL FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C60928 FOR SUSPENSION A product, usually a solid, intended for suspension prior to administration. FOR SUSP FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C60929 FOR SUSPENSION, EXTENDED RELEASE A product, usually a solid, intended for suspension prior to administration; once the suspension is administered, the drug will be released at a constant rate over a specified period. FOR SUSP ER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42933 GAS Any elastic aeriform fluid in which the molecules are separated from one another and have free paths. GAS FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42934 GEL A semisolid (1) dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion (2). A gel may contain suspended particles. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: A colloidal dispersion is a system in which particles of colloidal dimension (i.e., typically between 1 nm and 1 micrometer) are distributed uniformly throughout a liquid. GEL FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42906 GEL, DENTIFRICE A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth. GEL DENT FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C60930 GEL, METERED A gel preparation, with metered dose valves, which allow for the delivery of a uniform quantity of gel upon each activation. GEL MET FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C48193 GENERATOR An apparatus for the formation of vapor or gas from a liquid or solid by heat or chemical action. The term GENERATOR also applies to radioactive columns from which radionuclides are provided. GENERATOR FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42937 GLOBULE Also called pellets or pilules, are made of pure sucrose, lactose, or other polysaccharides. They are formed into small globular masses of various sizes, and are medicated by placing them in a vial and adding the liquid drug attenuation in the proportion not less than one percent (v/w). After shaking, the medicated globules are dried at temperatures not to exceed 40 degrees Centigrade. FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C45416 GRAFT A slip of skin or of other tissue for implantation. FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42938 GRANULE A small particle or grain. GRAN FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42903 GRANULE, DELAYED RELEASE A small medicinal particle or grain to which an enteric or other coating has been applied, thus delaying release of the drug until its passage into the intestines. GRAN DR FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42909 GRANULE, EFFERVESCENT A small particle or grain containing a medicinal agent in a dry mixture usually composed of sodium bicarbonate, citric acid, and tartaric acid which, when in contact with water, has the capability to release gas, resulting in effervescence. GRAN EFFRV FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42939 GRANULE, FOR SOLUTION A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient. GRAN F/SOL FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42940 GRANULE, FOR SUSPENSION A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing to form a suspension; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient. GRAN F/SUS FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42921 GRANULE, FOR SUSPENSION, EXTENDED RELEASE A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing to form a suspension; the extended release system achieves slow release of the drug over an extended period of time and maintains constant drug levels in the blood or target tissue. GRAN F/SUSP ER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42941 GUM A mucilaginous excretion from various plants. FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42894 GUM, CHEWING A sweetened and flavored insoluble plastic material of various shapes which when chewed, releases a drug substance into the oral cavity. GUM CHEWING FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42978 GUM, RESIN Natural mixture of gum and resin, usually obtained as exudations from plants. GUM RESIN FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42942 IMPLANT IMP FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42944 INHALANT A special class of inhalations consisting of a drug or combination of drugs, that by virtue of their high vapor pressure, can be carried by an air current into the nasal passage where they exert their effect; the container from which the inhalant generally is administered is known as an inhaler. FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C60931 INJECTABLE, LIPOSOMAL An injection, which either consists of or forms liposomes (a lipid bilayer vesicle usually composed of phospholipids which is used to encapsulate an active drug substance). INJ LIPOS FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42946 INJECTION A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP. INJ FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42914 INJECTION, EMULSION An emulsion consisting of a sterile, pyrogen-free preparation intended to be administered parenterally. INJ EMULSION FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42950 INJECTION, LIPID COMPLEX [definition pending] INJ LIPID COMPLEX FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42974 INJECTION, POWDER, FOR SOLUTION A sterile preparation intended for reconstitution to form a solution for parenteral use. INJ PWD F/SOL FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42976 INJECTION, POWDER, FOR SUSPENSION A sterile preparation intended for reconstitution to form a suspension for parenteral use. INJ PWD F/SUSP FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42977 INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE A dried preparation intended for reconstitution to form a suspension for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution). INJ PWD F/SUSP ER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42959 INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION A sterile freeze dried preparation intended for reconstitution for parenteral use which has been formulated in a manner that would allow liposomes (a lipid bilayer vesicle usually composed of phospholipids which is used to encapsulate an active drug substance, either within a lipid bilayer or in an aqueous space) to be formed upon reconstitution. INJ PWD LYO F/LS FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42957 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION A dosage form intended for the solution prepared by lyophilization ('freeze drying'), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections. INJ PWD LYO F/SOL FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42958 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION A liquid preparation, intended for parenteral use, that contains solids suspended in a suitable fluid medium and conforms in all respects to the requirements for Sterile Suspensions; the medicinal agents intended for the suspension are prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures. INJ PWD LYO F/SUSP FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42956 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE A sterile freeze dried preparation intended for reconstitution for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution). INJ PWD LYO F/SUSPER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42945 INJECTION, SOLUTION A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection. INJ SOL FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42899 INJECTION, SOLUTION, CONCENTRATE A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections. INJ SOL CONC FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42995 INJECTION, SUSPENSION A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa. INJ SUSP FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42926 INJECTION, SUSPENSION, EXTENDED RELEASE A sterile preparation intended for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form). INJ SUSP ER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42951 INJECTION, SUSPENSION, LIPOSOMAL A liquid preparation, suitable for injection, which consists of an oil phase dispersed throughout an aqueous phase in such a manner that liposomes (a lipid bilayer vesicle usually composed of phospholipids which is used to encapsulate an active drug substance, either within a lipid bilayer or in an aqueous space) are formed. INJ SUSP LIPOS FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42988 INJECTION, SUSPENSION, SONICATED A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. In addition, the product is sonicated while a gas is bubbled through the suspension, and this results in the formation of microspheres by the solid particles. INJ SUSP SON FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C60933 INSERT A specially formulated and shaped non-encapsulated solid preparation intended to be placed into a non-rectal orifice of the body, where drug is released, generally for localized effects. INSERT FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42922 INSERT, EXTENDED RELEASE A specially formulated and shaped non-encapsulated solid preparation intended to be placed into a non-rectal orifice of the body, where the medication is released, generally for localized effects; the extended release preparation is designed to allow for a reduction in dosing frequency. INSERT ER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C47915 INTRAUTERINE DEVICE A device inserted and left in the uterus to prevent effective conception. IUD FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42947 IRRIGANT A sterile solution intended to bathe or flush open wounds or body cavities; they're used topically, never parenterally. FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42948 JELLY A class of gels--semisolid systems which consist of suspensions made up of either small inorganic particles or large organic molecules interpenetrated by a liquid--in which the structural coherent matrix contains a high portion of liquid, usually water. JELLY FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C47916 KIT A packaged collection of related material. FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C45413 LINER, DENTAL A material applied to the inside of the dental cavity, for protection or insulation of the surface. LINER DENTAL FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42949 LINIMENT A solution or mixture of various substances in oil, alcoholic solutions of soap, or emulsions intended for external application. FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42952 LIPSTICK A waxy solid, usually colored cosmetic, in stick form for the lips. FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42953 LIQUID A dosage form consisting of a pure chemical in its liquid state. This dosage form term should not be applied to solutions. Note: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. LIQ FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C60934 LIQUID, EXTENDED RELEASE A liquid that delivers a drug in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. LIQ ER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C29167 LOTION An emulsion, liquid (1) dosage form. This dosage form is generally for external application to the skin (2). Note 1: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. Note 2: Previously the definition of a lotion was: The term lotion has been used to categorize many topical suspensions, solutions, and emulsions intended for application to the skin. The current definition of a lotion is restricted to an emulsion. LOTION FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C60957 LOTION, AUGMENTED A lotion dosage form that enhances drug delivery. Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered augmented. LOTION AUG FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C60958 LOTION/SHAMPOO A lotion dosage form which has a soap or detergent that is usually used to clean the hair and scalp; it is often used as a vehicle for dermatologic agents. LOTION SHAMPOO FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42955 LOZENGE A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick. LOZENGE FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C29269 MOUTHWASH An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect. MOUTHWASH FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C48624 NOT APPLICABLE The use of a dosage form term is not relevant or appropriate. NOT APPLICABLE FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42965 OIL An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils. OIL FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42966 OINTMENT A semisolid (1) dosage form, usually containing <20% water and volatiles (2) and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: Percent water and volatiles are measured by a loss on drying test in which the sample is heated at 105 degrees C until constant weight is achieved. OINTMENT FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C60984 OINTMENT, AUGMENTED An ointment dosage form that enhances drug delivery. Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered augmented. OINTMENT AUG FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C47887 PACKING A material, usually covered by or impregnated with a drug, that is inserted into a body cavity or between the tooth enamel and the gingival margin. PACKING FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42967 PASTE A semisolid dosage form, containing a large proportion (20 - 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes. Note: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42907 PASTE, DENTIFRICE A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents. PASTE DENT FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C60985 PASTILLE An aromatic preparation, often with a pleasing flavor, usually intended to dissolve in the mouth. PASTILLE FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42968 PATCH A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms Extended Release Film and System. PATCH FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42923 PATCH, EXTENDED RELEASE A drug delivery system in the form of a patch that releases the drug in such a manner that a reduction in dosing frequency compared to that drug presented as a conventional dosage form (e.g., a solution or a prompt drug-releasing, conventional solid dosage form). PATCH ER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42911 PATCH, EXTENDED RELEASE, ELECTRICALLY CONTROLLED A drug delivery system in the form of a patch which is controlled by an electric current that releases the drug in such a manner that a reduction in dosing frequency compared to that drug presented as a conventional dosage form (e.g., a solution or a prompt drug-releasing, conventional solid dosage form). PATCH ER ELCON FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42969 PELLET A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding. PELLET FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42943 PELLET, IMPLANTABLE A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding; they are intended for implantation in the body (usually subcutaneously) for the purpose of providing continuous release of the drug over long periods of time. PELLET IMP FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42918 PELLETS, COATED, EXTENDED RELEASE A solid dosage form in which the drug itself is in the form of granules to which varying amounts of coating have been applied, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form PELLETS COATED ER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42636 PHARMACEUTICAL DOSAGE FORM FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C25394 PILL A small, round solid dosage form containing a medicinal agent intended for oral administration. PILL FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42970 PLASTER Substance intended for external application made of such materials and of such consistency as to adhere to the skin and attach to a dressing; plasters are intended to afford protection and support and/or to furnish an occlusion and macerating action and to bring medication into close contact with the skin. FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C47913 POULTICE A soft, moist mass of meal, herbs, seed, etc., usually applied hot in cloth that consists of gruel-like consistency. POULTICE FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42972 POWDER An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use. PWD FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42908 POWDER, DENTIFRICE A powder formulation intended to clean and/or polish the teeth, and which may contain certain additional agents. PWD DENT FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42973 POWDER, FOR SOLUTION An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution. PWD F/SOL FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42975 POWDER, FOR SUSPENSION An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle). PWD F/SUSP FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42961 POWDER, METERED A powder dosage form that is situated inside a container that has a mechanism to deliver a specified quantity. PWD MET FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C60988 RING A small circular object with a vacant circular center that is usually intended to be placed in the body by special inserters, where the medication is released, generally for localized effects. RING FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42979 RINSE A liquid used to cleanse by flushing. RINSE FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42980 SALVE A thick ointment or cerate (a fat or wax based preparation with a consistency between an ointment and a plaster). SALVE FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42981 SHAMPOO A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents. SHAMPOO FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42982 SHAMPOO, SUSPENSION A liquid soap or detergent containing one or more solid, insoluble substances dispersed in a liquid vehicle that is used to clean the hair and scalp and is often used as a vehicle for dermatologic agents. SHAMPOO SUSP FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42983 SOAP Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic. SOAP FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42986 SOLUTION A clear, homogeneous liquid dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents. Note: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. SOL FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42898 SOLUTION, CONCENTRATE A liquid preparation (i.e., a substance that flows readily in its natural state) that contains a drug dissolved in a suitable solvent or mixture of mutually miscible solvents; the drug has been strengthened by the evaporation of its non-active parts. SOL CONC FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42987 SOLUTION, FOR SLUSH A solution for the preparation of an iced saline slush, which is administered by irrigation and used to induce regional hypothermia (in conditions such as certain open heart and kidney surgical procedures) by its direct application. SOL F/SLUSH FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42935 SOLUTION, GEL FORMING, EXTENDED RELEASE A solution that forms a gel when it comes in contact with ocular fluid, and which allows at least a reduction in dosing frequency SOL GF ER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C60994 SOLUTION, GEL FORMING/DROPS A solution, which after usually being administered in a drop-wise fashion, forms a gel. SOL GF DROPS FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C60992 SOLUTION/DROPS A solution which is usually administered in a drop-wise fashion. SOL DROPS FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C47912 SPONGE A porous, interlacing, absorbent material that contains a drug. It is typically used for applying or introducing medication, or for cleansing. A sponge usually retains its shape. SPONGE FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42989 SPRAY A liquid minutely divided as by a jet of air or steam. FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42962 SPRAY, METERED A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation. SPRAY MET FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42990 SPRAY, SUSPENSION A liquid preparation containing solid particles dispersed in a liquid vehicle and in the form of coarse droplets or as finely divided solids to be applied locally, most usually to the nasal-pharyngeal tract, or topically to the skin. SPRAY SUSP FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42991 STICK A dosage form prepared in a relatively long and slender often cylindrical form. STICK FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C47914 STRIP A long narrow piece of material. STRIP FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42993 SUPPOSITORY A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature. SUPP FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42924 SUPPOSITORY, EXTENDED RELEASE A drug delivery system in the form of a suppository that allows for a reduction in dosing frequency. SUPP ER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42994 SUSPENSION A liquid dosage form that contains solid particles dispersed in a liquid vehicle. Note: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. SUSP FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42925 SUSPENSION, EXTENDED RELEASE A liquid preparation consisting of solid particles dispersed throughout a liquid phase in which the particles are not soluble; the suspension has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form). SUSP ER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C60995 SUSPENSION/DROPS A suspension which is usually administered in a dropwise fashion. SUSP DROPS FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C47889 SUTURE A strand or fiber used to hold wound edges in apposition during healing. FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C47898 SWAB A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab is typically used for applying medication or for cleansing. FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42996 SYRUP An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions. SYRUP FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42998 TABLET A solid dosage form containing medicinal substances with or without suitable diluents. TAB FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42893 TABLET, CHEWABLE A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste. TAB CHEW FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42897 TABLET, COATED A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating. TAB COATED FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C60997 TABLET, COATED PARTICLES A solid dosage form containing a conglomerate of medicinal particles that have each been covered with a coating. TAB COATED PART FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42905 TABLET, DELAYED RELEASE A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms. TAB DR FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42997 TABLET, DELAYED RELEASE PARTICLES A solid dosage form containing a conglomerate of medicinal particles that have been covered with a coating which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms. TAB DR PARTICLES FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42910 TABLET, EFFERVESCENT A solid dosage form containing mixtures of acids (e.g., citric acid, tartaric acid) and sodium bicarbonate, which release carbon dioxide when dissolved in water; it is intended to be dissolved or dispersed in water before administration. TAB EFFRV FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42927 TABLET, EXTENDED RELEASE A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form. TAB ER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42931 TABLET, FILM COATED A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer. TAB FILM COATED FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42930 TABLET, FILM COATED, EXTENDED RELEASE A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion. TAB FILM COATED ER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C61004 TABLET, FOR SOLUTION A tablet that forms a solution when placed in a liquid. TAB FOR SOL FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C61005 TABLET, FOR SUSPENSION A tablet that, prior to administration, is intended to be placed in liquid, where its contents will be distributed evenly throughout that liquid. Note: The term Tablet, Dispersible is no longer used for approved drug products, and it has been replaced by the term tablet, for suspension. TAB DISP|TAB FOR SUSP|TABLET, FOR SUSPENSION FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42964 TABLET, MULTILAYER A solid dosage form containing medicinal substances that have been compressed to form a multiple-layered tablet or a tablet-within-a-tablet, the inner tablet being the core and the outer portion being the shell. TAB MULTILAYER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42963 TABLET, MULTILAYER, EXTENDED RELEASE A solid dosage form containing medicinal substances that have been compressed to form a multiple-layered tablet or a tablet-within-a-tablet, the inner tablet being the core and the outer portion being the shell, which, additionally, is covered in a designated coating; the tablet is formulated in such manner as to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form. TAB MULTILAYER ER FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42999 TABLET, ORALLY DISINTEGRATING A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue. TAB ORALLY DIS FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C61006 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue, but which releases a drug (or drugs) at a time other than promptly after administration. TAB ORALLY DIS DR FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42985 TABLET, SOLUBLE A solid dosage form that contains medicinal substances with or without suitable diluents and possesses the ability to dissolve in fluids. TAB SOLUBLE FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C42992 TABLET, SUGAR COATED A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a colored or an uncolored water-soluble sugar. TAB SUGAR COATED FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C47892 TAMPON A plug made of cotton, sponge, or oakum variously used in surgery to plug the nose, vagina, etc., for the control of hemorrhage or the absorption of secretions. FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C47897 TAPE A narrow woven fabric, or a narrow extruded synthetic (such as plastic), usually with an adhesive on one or both sides. FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C43000 TINCTURE An alcoholic or hydroalcoholic solution prepared from vegetable materials or from chemical substances. FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C43001 TROCHE A discoid-shaped solid containing the medicinal agent in a suitably flavored base; troches are placed in the mouth where they slowly dissolve, liberating the active ingredients. TROCHE FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C43002 UNASSIGNED A dosage form has yet to be assigned. FDA C54456 Structured Product Labeling Pharmaceutical Dosage Form Terminology C43003 WAFER A thin slice of material containing a medicinal agent. WAFER FDA C54458 Structured Product Labeling Potency Terminology C48472 ADJUST PH LITERAL ADJ PH FDA C54458 Structured Product Labeling Potency Terminology C48473 AMPULE LITERAL AMPULE FDA C54458 Structured Product Labeling Potency Terminology C62412 APPLICATOR LITERAL AP FDA C54458 Structured Product Labeling Potency Terminology C48474 BAG LITERAL BAG FDA C54458 Structured Product Labeling Potency Terminology C48475 BAR LITERAL FDA C54458 Structured Product Labeling Potency Terminology C53495 BEAD LITERAL FDA C54458 Structured Product Labeling Potency Terminology C54564 BLISTER LITERAL BLISTER FDA C54458 Structured Product Labeling Potency Terminology C61569 BLISTER PACK LITERAL BLPK FDA C54458 Structured Product Labeling Potency Terminology C53498 BLOCK LITERAL FDA C54458 Structured Product Labeling Potency Terminology C48476 BOLUS LITERAL BOL FDA C54458 Structured Product Labeling Potency Terminology C48477 BOTTLE LITERAL BOT FDA C54458 Structured Product Labeling Potency Terminology C48478 BOX LITERAL FDA C54458 Structured Product Labeling Potency Terminology C48479 CAN LITERAL FDA C54458 Structured Product Labeling Potency Terminology C62413 CANISTER LITERAL CSTR FDA C54458 Structured Product Labeling Potency Terminology C48480 CAPSULE LITERAL CAP FDA C54458 Structured Product Labeling Potency Terminology C48464 CAROTID SINUS RHYTHM UNITS LITERAL CSRU FDA C54458 Structured Product Labeling Potency Terminology C54702 CARTON LITERAL FDA C54458 Structured Product Labeling Potency Terminology C48481 CARTRIDGE LITERAL CTG FDA C54458 Structured Product Labeling Potency Terminology C62414 CASE LITERAL FDA C54458 Structured Product Labeling Potency Terminology C62274 CELLO PACK LITERAL CELLO FDA C54458 Structured Product Labeling Potency Terminology C48482 CLINICAL UNITS LITERAL CU FDA C54458 Structured Product Labeling Potency Terminology C48483 COAT LITERAL FDA C54458 Structured Product Labeling Potency Terminology C48484 CONTAINER LITERAL CTR FDA C54458 Structured Product Labeling Potency Terminology C48485 COUNT LITERAL CNT FDA C54458 Structured Product Labeling Potency Terminology C48488 CUBIC INCH LITERAL CU IN FDA C54458 Structured Product Labeling Potency Terminology C54703 CUP LITERAL FDA C54458 Structured Product Labeling Potency Terminology C48466 CURIE LITERAL CI FDA C54458 Structured Product Labeling Potency Terminology C48489 CYLINDER LITERAL CYL FDA C54458 Structured Product Labeling Potency Terminology C62415 DEWAR LITERAL DEW FDA C54458 Structured Product Labeling Potency Terminology C62416 DIALPACK LITERAL DLPK FDA C54458 Structured Product Labeling Potency Terminology C48490 DISK LITERAL FDA C54458 Structured Product Labeling Potency Terminology C62417 DOSE PACK LITERAL DSPK FDA C54458 Structured Product Labeling Potency Terminology C48491 DROPS LITERAL DROPS FDA C54458 Structured Product Labeling Potency Terminology C48492 DRUM LITERAL FDA C54458 Structured Product Labeling Potency Terminology C48487 FEET, CUBIC LITERAL CU FT FDA C54458 Structured Product Labeling Potency Terminology C48461 FEET, SQUARE LITERAL SQ FT FDA C54458 Structured Product Labeling Potency Terminology C53499 FILM LITERAL FDA C54458 Structured Product Labeling Potency Terminology C48493 FLUID DRAM LITERAL FL DR FDA C54458 Structured Product Labeling Potency Terminology C48494 FLUID OUNCE LITERAL FL OZ FDA C54458 Structured Product Labeling Potency Terminology C48580 GALLON LITERAL GAL FDA C54458 Structured Product Labeling Potency Terminology C48496 GENERATOR LITERAL GEN FDA C54458 Structured Product Labeling Potency Terminology C48497 GRAIN LITERAL GR FDA C54458 Structured Product Labeling Potency Terminology C48155 GRAM LITERAL GM FDA C54458 Structured Product Labeling Potency Terminology C48498 HOMEOPATHIC DILUTION LITERAL X FDA C54458 Structured Product Labeling Potency Terminology C25529 HOUR LITERAL FDA C54458 Structured Product Labeling Potency Terminology C48499 IMPLANT LITERAL IMP FDA C54458 Structured Product Labeling Potency Terminology C48500 INCH LITERAL IN FDA C54458 Structured Product Labeling Potency Terminology C48501 INHALATION LITERAL INH FDA C54458 Structured Product Labeling Potency Terminology C62275 INHALER LITERAL INHL FDA C54458 Structured Product Labeling Potency Terminology C62418 INHALER, REFILL LITERAL INHLRE FDA C54458 Structured Product Labeling Potency Terminology C62276 INSERT LITERAL INSERT FDA C54458 Structured Product Labeling Potency Terminology C48579 INTERNATIONAL UNITS LITERAL IU FDA C54458 Structured Product Labeling Potency Terminology C48502 JAR LITERAL FDA C54458 Structured Product Labeling Potency Terminology C62419 JUG LITERAL FDA C54458 Structured Product Labeling Potency Terminology C48503 KALLIKREIN INHIBITOR UNIT LITERAL KIU FDA C54458 Structured Product Labeling Potency Terminology C28252 KILOGRAM LITERAL KG FDA C54458 Structured Product Labeling Potency Terminology C48504 KIT LITERAL KIT FDA C54458 Structured Product Labeling Potency Terminology C48505 LITER LITERAL L FDA C54458 Structured Product Labeling Potency Terminology C48506 LOZENGE LITERAL LOZ FDA C54458 Structured Product Labeling Potency Terminology C48507 MICROCURIE LITERAL UCI FDA C54458 Structured Product Labeling Potency Terminology C48152 MICROGRAM LITERAL UGM FDA C54458 Structured Product Labeling Potency Terminology C48153 MICROLITER LITERAL UL FDA C54458 Structured Product Labeling Potency Terminology C48508 MICROMOLAR LITERAL UMOLAR FDA C54458 Structured Product Labeling Potency Terminology C48509 MICROMOLE LITERAL UMOLE FDA C54458 Structured Product Labeling Potency Terminology C48510 MICRON LITERAL MCN FDA C54458 Structured Product Labeling Potency Terminology C48511 MILLICURIE LITERAL MCI FDA C54458 Structured Product Labeling Potency Terminology C48512 MILLIEQUIVALENT LITERAL MEQ FDA C54458 Structured Product Labeling Potency Terminology C28253 MILLIGRAM LITERAL MG FDA C54458 Structured Product Labeling Potency Terminology C28254 MILLILITER LITERAL ML FDA C54458 Structured Product Labeling Potency Terminology C28251 MILLIMETER LITERAL MM FDA C54458 Structured Product Labeling Potency Terminology C48513 MILLIMOLE LITERAL MMOLE FDA C54458 Structured Product Labeling Potency Terminology C48514 MINIM LITERAL FDA C54458 Structured Product Labeling Potency Terminology C48578 MISCELLANEOUS LITERAL MISC FDA C54458 Structured Product Labeling Potency Terminology C48555 MOLAR LITERAL FDA C54458 Structured Product Labeling Potency Terminology C42539 MOLE LITERAL FDA C54458 Structured Product Labeling Potency Terminology C48516 NANOGRAM LITERAL NGM FDA C54458 Structured Product Labeling Potency Terminology C48517 NANOMOLE LITERAL NMOLE FDA C54458 Structured Product Labeling Potency Terminology C48554 NORMAL LITERAL N FDA C54458 Structured Product Labeling Potency Terminology C48587 NOT APPLICABLE LITERAL N/A FDA C54458 Structured Product Labeling Potency Terminology C48519 OUNCE LITERAL OZ FDA C54458 Structured Product Labeling Potency Terminology C48520 PACKAGE LITERAL PKG FDA C54458 Structured Product Labeling Potency Terminology C48521 PACKET LITERAL PKT FDA C54458 Structured Product Labeling Potency Terminology C48523 PART PER MILLION LITERAL PPM FDA C54458 Structured Product Labeling Potency Terminology C48522 PARTS LITERAL FDA C54458 Structured Product Labeling Potency Terminology C48524 PATCH LITERAL PATCH FDA C54458 Structured Product Labeling Potency Terminology C48525 PELLET LITERAL PEL FDA C54458 Structured Product Labeling Potency Terminology C48570 PERCENT LITERAL % FDA C54458 Structured Product Labeling Potency Terminology C48571 PERCENT VOLUME/VOLUME LITERAL %V/V FDA C54458 Structured Product Labeling Potency Terminology C48527 PERCENT WEIGHT/VOLUME LITERAL %W/V FDA C54458 Structured Product Labeling Potency Terminology C48528 PERCENT WEIGHT/WEIGHT LITERAL %W/W FDA C54458 Structured Product Labeling Potency Terminology C48588 POTENCY NOT GIVEN LITERAL PNG FDA C54458 Structured Product Labeling Potency Terminology C48470 POTENCY UNIT The basic quantity or increment used to describe the strength of a product or amount of product in a package. FDA C54458 Structured Product Labeling Potency Terminology C48530 POUCH LITERAL POUCH FDA C54458 Structured Product Labeling Potency Terminology C48531 POUND LITERAL LB FDA C54458 Structured Product Labeling Potency Terminology C48532 PRESSOR UNITS LITERAL PRU FDA C54458 Structured Product Labeling Potency Terminology C48533 PROTEIN UNIT LITERAL PNU FDA C54458 Structured Product Labeling Potency Terminology C48590 QUANTITY SUFFICIENT LITERAL QS FDA C54458 Structured Product Labeling Potency Terminology C48534 QUART LITERAL QT FDA C54458 Structured Product Labeling Potency Terminology C62609 RING LITERAL FDA C54458 Structured Product Labeling Potency Terminology C48535 SATURATED LITERAL SAT FDA C54458 Structured Product Labeling Potency Terminology C48536 SCOOPFUL LITERAL SCP FDA C54458 Structured Product Labeling Potency Terminology C53502 SPONGE LITERAL FDA C54458 Structured Product Labeling Potency Terminology C48537 SPRAY LITERAL FDA C54458 Structured Product Labeling Potency Terminology C48460 SQUARE CENTIMETER LITERAL SQ CM FDA C54458 Structured Product Labeling Potency Terminology C48462 SQUARE YARD LITERAL SQ YD FDA C54458 Structured Product Labeling Potency Terminology C53503 STICK LITERAL FDA C54458 Structured Product Labeling Potency Terminology C48538 STRIP LITERAL STRIP FDA C54458 Structured Product Labeling Potency Terminology C62420 SUPERSACK LITERAL FDA C54458 Structured Product Labeling Potency Terminology C48539 SUPPOSITORY LITERAL SUPP FDA C54458 Structured Product Labeling Potency Terminology C53504 SWAB LITERAL FDA C54458 Structured Product Labeling Potency Terminology C48540 SYRINGE LITERAL SYR FDA C54458 Structured Product Labeling Potency Terminology C48541 TABLESPOON LITERAL TBSP FDA C54458 Structured Product Labeling Potency Terminology C48542 TABLET LITERAL TAB FDA C54458 Structured Product Labeling Potency Terminology C62421 TABMINDER LITERAL TABMIND FDA C54458 Structured Product Labeling Potency Terminology C48543 TAMPON LITERAL TAMP FDA C54458 Structured Product Labeling Potency Terminology C62422 TANK LITERAL FDA C54458 Structured Product Labeling Potency Terminology C48544 TEASPOON LITERAL TSP FDA C54458 Structured Product Labeling Potency Terminology C48545 TEST LITERAL FDA C54458 Structured Product Labeling Potency Terminology C48546 TON LITERAL TON FDA C54458 Structured Product Labeling Potency Terminology C48547 TRACE LITERAL TRACE FDA C54458 Structured Product Labeling Potency Terminology C54704 TRAY LITERAL FDA C54458 Structured Product Labeling Potency Terminology C48548 TROCHE LITERAL TRO FDA C54458 Structured Product Labeling Potency Terminology C48549 TUBE LITERAL TUBE FDA C54458 Structured Product Labeling Potency Terminology C48591 UNASSIGNED LITERAL U/A FDA C54458 Structured Product Labeling Potency Terminology C48469 UNITED STATES PHARMACOPEIA UNIT LITERAL USP UNIT FDA C54458 Structured Product Labeling Potency Terminology C48931 UNITS LITERAL UNITS FDA C54458 Structured Product Labeling Potency Terminology C48551 VIAL LITERAL FDA C54458 Structured Product Labeling Potency Terminology C48552 WAFER LITERAL WAFER FDA C54458 Structured Product Labeling Potency Terminology C48553 YARD LITERAL YD FDA C54454 Structured Product Labeling Shape Terminology C48335 BULLET The shape of a cylinder when viewing the capsule from a point perpendicular to its longest side, with a point at one end. The bullet shape is synonymous with torpedo shape. FDA C54454 Structured Product Labeling Shape Terminology C48336 CAPSULE The shape of a capsule when viewing the capsule from a point perpendicular to its longest side. The capsule shape is reserved for two-part capsules and banded two-part capsules. Tablets with a capsule shape or a one part capsules (e.g., soft gelatin capsules that are filled with a liquid) should be classified under OVAL. FDA C54454 Structured Product Labeling Shape Terminology C48337 CLOVER The stylized shape, of clover, having three or four leaves with or without the stem. FDA C54454 Structured Product Labeling Shape Terminology C48338 DIAMOND The shape has four distinct sides making a parallelogram with two inner obtuse angles and two inner acute angles. A square with diagonal imprinting is not a diamond, but rather, a square. See also SQUARE. FDA C54454 Structured Product Labeling Shape Terminology C48339 DOUBLE CIRCLE The shape of two circles joined together, and usually overlapping. FDA C54454 Structured Product Labeling Shape Terminology C48340 FREEFORM The shape does not have 3 or more distinct sides and is not one of the listed shapes. Examples include, but are not limited to, airplane, apple, cartoon characters, heart, kidney, shield, and train shapes. FDA C54454 Structured Product Labeling Shape Terminology C48341 GEAR The two dimensional shape of a toothed wheel of a machine part. FDA C54454 Structured Product Labeling Shape Terminology C48342 HEPTAGON (7 sided) The shape has seven distinct sides. The sides may be straight or slightly curved. It can either be regular (interior angles are equal and its sides are equal in length) or irregular (interior angles are not equal and/or its sides are not equal in length). FDA C54454 Structured Product Labeling Shape Terminology C48343 HEXAGON (6 sided) The shape has six distinct sides. The sides may be straight or slightly curved. It can either be regular (interior angles are equal and its sides are equal in length) or irregular (interior angles are not equal and/or its sides are not equal in length). FDA C54454 Structured Product Labeling Shape Terminology C48344 OCTAGON (8 sided) The shape has eight distinct sides. The sides may be straight or slightly curved. It can either be regular (interior angles are equal and its sides are equal in length) or irregular (interior angles are not equal and/or its sides are not equal in length). FDA C54454 Structured Product Labeling Shape Terminology C48345 OVAL The shape of either an oval or an ellipse. See also TEAR. FDA C54454 Structured Product Labeling Shape Terminology C48346 PENTAGON (5 sided) The shape has five distinct sides. The sides may be straight or slightly curved. It can either be regular (interior angles are equal and its sides are equal in length) or irregular (interior angles are not equal and/or its sides are not equal in length). FDA C54454 Structured Product Labeling Shape Terminology C48347 RECTANGLE The shape has four distinct sides and four right angles but is not a square. FDA C54454 Structured Product Labeling Shape Terminology C48348 ROUND The shape of a circle. Spherical shapes are called round because their two dimensional projections are round. FDA C54454 Structured Product Labeling Shape Terminology C48349 SEMI-CIRCLE The shape of half of a circle or half of an oval. This shape is also used for shapes similar to the letter D or the letter U. Any letter D or U that is either embossed or debossed onto the surface of a dosage form is not used in determining the shape of that dosage form. FDA C54454 Structured Product Labeling Shape Terminology C48350 SQUARE The shape has four distinct and equal sides with four right angles. The sides may be straight or slightly curved. A square tilted at a 45 degree angle so that the diagonals run vertical and horizontal is not a diamond, but rather, a square. See also DIAMOND. FDA C54454 Structured Product Labeling Shape Terminology C48351 TEAR The stylized shape of a tear or drop of water. It differs from an oval because one end is clearly larger than the other. It is synonymous with the shapes egg, pear, and almond. See also oval. FDA C54454 Structured Product Labeling Shape Terminology C48352 TRAPEZOID The shape has four distinct sides. The sides may be straight or slightly curved. Only two of the sides are parallel. FDA C54454 Structured Product Labeling Shape Terminology C48353 TRIANGLE The shape has three distinct sides. The sides may be straight or slightly curved. It can either be regular (interior angles are equal and its sides are equal in length) or irregular (interior angles are not equal and/or its sides are not equal in length). FDA C54452 Structured Product Labeling Terminology C16352 African American FDA C54452 Structured Product Labeling Terminology C41259 American Indian or Alaska Native FDA C54452 Structured Product Labeling Terminology C41260 Asian FDA C54452 Structured Product Labeling Terminology C60654 Conditional Approval FDA C54452 Structured Product Labeling Terminology C50646 Contraindication Any special symptom or circumstance that renders the use of a remedy or the carrying out of a procedure inadvisable, usually because of the risk. FDA C54452 Structured Product Labeling Terminology C54356 Decrease Drug Level FDA C54452 Structured Product Labeling Terminology C54614 Decreased Concomitant Drug AUC FDA C54452 Structured Product Labeling Terminology C54615 Decreased Concomitant Drug Cmax FDA C54452 Structured Product Labeling Terminology C54616 Decreased Concomitant Drug Half Life FDA C54452 Structured Product Labeling Terminology C54358 Decreased Concomitant Drug Level FDA C54452 Structured Product Labeling Terminology C54617 Decreased Concomitant Drug Tmax FDA C54452 Structured Product Labeling Terminology C54609 Decreased Drug AUC FDA C54452 Structured Product Labeling Terminology C54606 Decreased Drug Cmax FDA C54452 Structured Product Labeling Terminology C54607 Decreased Drug Half Life FDA C54452 Structured Product Labeling Terminology C54608 Decreased Drug Tmax FDA C54452 Structured Product Labeling Terminology C54415 Diagnostic For FDA C54452 Structured Product Labeling Terminology C54346 Dose Modification FDA C54452 Structured Product Labeling Terminology C60655 Duration Of Use FDA C54452 Structured Product Labeling Terminology C16576 Female FDA C54452 Structured Product Labeling Terminology C54357 Increase Concomitant Drug Level FDA C54452 Structured Product Labeling Terminology C54613 Increased Concomitant Drug AUC FDA C54452 Structured Product Labeling Terminology C54610 Increased Concomitant Drug Cmax FDA C54452 Structured Product Labeling Terminology C54611 Increased Concomitant Drug Half Life FDA C54452 Structured Product Labeling Terminology C54612 Increased Concomitant Drug Tmax FDA C54452 Structured Product Labeling Terminology C54605 Increased Drug AUC FDA C54452 Structured Product Labeling Terminology C54602 Increased Drug Cmax FDA C54452 Structured Product Labeling Terminology C54603 Increased Drug Half Life FDA C54452 Structured Product Labeling Terminology C54355 Increased Drug Level FDA C54452 Structured Product Labeling Terminology C54604 Increased Drug Tmax FDA C54452 Structured Product Labeling Terminology C54344 Limitation Of Use FDA C54452 Structured Product Labeling Terminology C54352 Limited Or No Information FDA C54452 Structured Product Labeling Terminology C20197 Male FDA C54452 Structured Product Labeling Terminology C54027 Medical Problem Patient Problem Code|Patient Problem FDA C54452 Structured Product Labeling Terminology C54390 Medical Product Intent Of Use FDA C54452 Structured Product Labeling Terminology C54416 Mitigation FDA C54452 Structured Product Labeling Terminology C41219 Native Hawaiian or Other Pacific Islander FDA C54452 Structured Product Labeling Terminology C54386 Pharmacokinetic Effect FDA C54452 Structured Product Labeling Terminology C54354 Pharmacokinetic Effect Consequences FDA C54452 Structured Product Labeling Terminology C54404 Prophylaxis For FDA C54452 Structured Product Labeling Terminology C17049 Race FDA C54452 Structured Product Labeling Terminology C54350 Second Line Treatment FDA C54452 Structured Product Labeling Terminology C28421 Sex FDA C54452 Structured Product Labeling Terminology C54398 Treat FDA C54452 Structured Product Labeling Terminology C54351 Use With Caution FDA C54618 Structured Product Labeling Type of Drug Interaction Consequence Terminology C54027 Medical Problem Patient Problem Code|Patient Problem FDA C54618 Structured Product Labeling Type of Drug Interaction Consequence Terminology C54386 Pharmacokinetic Effect