A	C96069	Stability Data Standards Terminology	C96080	Stability Container Closure System Terminology	Terminology developed to support Closure Systems within the Stability Data Standards.	Stability Container Closure System Terminology	The closure system of the container.
A	C96069	Stability Data Standards Terminology	C96081	Stability Container Type Terminology	Terminology developed to support Container Types within the Stability Data Standards.	Stability Container Type Terminology	As reported entity or as part of a reported packaged product, this is the official code for a referenced package type. For FDA implementation, only the display Name (i.e., the product name is mandatory, the code values might be provided if available).
A	C96069	Stability Data Standards Terminology	C96074	Stability Product Form Terminology	Terminology developed to support Product Forms within the Stability Data Standards.	Stability Product Form Terminology	This code describes the form of the reported product. Code values might be provided if available (e.g., when used in other submissions like SPL).
A	C96069	Stability Data Standards Terminology	C96072	Stability Product Identifier Terminology	Terminology developed to support Product Identifiers within the Stability Data Standards.	Stability Product Identifier Terminology	This is the code for the official product name. For FDA implementation, only the "displayName" (i.e., the product name) is mandatory, the code values might be provided if available (e.g., when used in other submissions like SPL). For NDA this is a new identifier. For ongoing studies the identifier should be identical to an already submitted code, so that a unique relationship can be established.
A	C96069	Stability Data Standards Terminology	C96071	Stability Study Data File Reason Terminology	Terminology developed to support Data File Reasons within the Stability Data Standards.	Stability Study Data File Reason Terminology	This code should indicate the type of application the data supports or whether the data is submitted to an existing application. The codes indicate that the data is part of an Annual Report, New Drug Application, New Active Ingredient, Biologics License Application, Premarket Approval, or Supplement to an Approved Application.
A	C96069	Stability Data Standards Terminology	C96070	Stability Study Data File Type Terminology	Terminology developed to support Data File Types within the Stability Data Standards.	Stability Study Data File Type Terminology	This code should reflect if the file in hand is a standard data file for one storage condition or a partial file as part of a cycled study.
A	C96069	Stability Data Standards Terminology	C96078	Stability Study Interpretation Terminology	Terminology developed to support Study Interpretations within the Stability Data Standards.	Stability Study Interpretation Terminology	For a single acceptance criterion (i.e., limit) this code describes how to relate the given value to a measured value, (e.g., a result should not be greater (not more) than the given value). The common accepted nomenclature should be used here.
A	C96069	Stability Data Standards Terminology	C96077	Stability Study Method Type Terminology	Terminology developed to support Study Method Types within the Stability Data Standards.	Stability Study Method Type Terminology	A classification of the methods used in stability testing.
A	C96069	Stability Data Standards Terminology	C96083	Stability Study Pause Description Terminology	Terminology developed to support Pause Descriptions within the Stability Data Standards.	Stability Study Pause Description Terminology	This code describes any delay that happened during testing, e.g. none (Immediate) or freeze sample (Delayed Frozen).
A	C96069	Stability Data Standards Terminology	C96082	Stability Study Storage Condition Terminology	Terminology developed to support Storage Conditions within the Stability Data Standards.	Stability Study Storage Condition Terminology	The code provided represents a storage condition. Dependent of the internal company definitions this condition might be simple (e.g., 25 degrees) or complex (e.g., 25 degrees C/60% R.H. upright).
A	C96069	Stability Data Standards Terminology	C96076	Stability Study Test Terminology	Terminology developed to support Study Tests within the Stability Data Standards.	Stability Study Test Terminology	This code describes the test performed during a study within the specification sheet.
A	C96069	Stability Data Standards Terminology	C96079	Stability Study Type Terminology	Terminology developed to support Study Types within the Stability Data Standards.	Stability Study Type Terminology	This code classifies the type of study performed on the given Research Subject, e.g., Commercial, Development, Clinical.
A	C96069	Stability Data Standards Terminology	C96075	Stability Substance Identifier Terminology	Terminology developed to support Substance Identifiers within the Stability Data Standards.	Stability Substance Identifier Terminology	The official code for a referenced substance (e.g., acetylsalicylic acid), as a single entity or part of a product (e.g., aspirin). For FDA implementation, only the displayName (i.e. the product name) is mandatory, the code values might be provided if available (e.g., when used in other submissions like SPL), please refer to Substance Registration System - Unique Ingredient Identifier (UNII), at http://www.fda.gov/oc/datacouncil/spl.html. If you have a new compound that is not in the Substance Registration System (SRS) it can be registered by contacting fda-srs(at)fda.hhs.gov. The compound can be given a code and the other information about the compound can remain confidential.
A	C96077	Stability Study Method Type Terminology	C96164	Code of Federal Regulations Method		CFR Regulation	Method dictated by CFR.
D	C96074	Stability Product Form Terminology	C42636	Pharmaceutical Dosage Form	The form in which active and/or inert ingredient(s) are physically presented.	Product Form	This code describes the form of the reported product. Code values might be provided if available (e.g., when used in other submissions like SPL).
D	C96081	Stability Container Type Terminology	C43164	Package Type	This standard provides for all types of packages that bulk drug substances and final drug dosage forms are contained in, including both the immediate (or primary) and secondary containers.	Container	As reported entity or as part of a reported packaged product, this is the official code for a referenced package type. For FDA implementation, only the display Name (i.e., the product name is mandatory, the code values might be provided if available).
D	C96071	Stability Study Data File Reason Terminology	C80442	Premarket Notification 510(K)	A premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective as a legally marketed device that is not subject to PMA (Premarket Authorization).	Premarket Notification (510K)	Stability data submitted for a premarket 510(k) submission.
D	C96070	Stability Study Data File Type Terminology	C96084	Stability Study Data File Type		Type of Data File for Stability Study	This code should reflect if the file in hand is a standard data file for one storage condition or a partial file as part of a cycled study.
D	C96071	Stability Study Data File Reason Terminology	C96088	Stability Study Data File Reason		Reason for Data File for Stability Study	This code should indicate the type of application the data supports or whether the data is submitted to an existing application. The codes indicate that the data is part of an Annual Report, New Drug Application, New Active Ingredient, Biologics License Application, Premarket Approval, or Supplement to an Approved Application.
D	C96072	Stability Product Identifier Terminology	C96095	Product Identifier		Product	This is the code for the official product name. For FDA implementation, only the displayName (i.e., the product name) is mandatory, the code values might be provided if available (e.g., when used in other submissions like SPL). For NDA this is a new identifier. For ongoing studies the identifier should be identical to an already submitted code, so that a unique relationship can be established.
D	C96075	Stability Substance Identifier Terminology	C96096	Substance Identifier		Substance	The official code for a referenced substance (e.g., acetylsalicylic acid), as a single entity or part of a product (e.g., aspirin). For FDA implementation, only the displayName (i.e. the product name) is mandatory, the code values might be provided if available (e.g., when used in other submissions like SPL), please refer to Substance Registration System - Unique Ingredient Identifier (UNII), at http://www.fda.gov/oc/datacouncil/spl.html. If you have a new compound that is not in the Substance Registration System (SRS) it can be registered by contacting fda-srs(at)fda.hhs.gov. The compound can be given a code and the other information about the compound can remain confidential.
D	C96076	Stability Study Test Terminology	C96097	Stability Study Test		Stability Study Test	This code describes the test performed during a study within the specification sheet.
D	C96077	Stability Study Method Type Terminology	C96101	Stability Study Method Type		Stability Study Method Type	A classification of the methods used in stability testing.
D	C96078	Stability Study Interpretation Terminology	C96105	Stability Study Interpretation		Stability Study Interpretation	For a single acceptance criterion (i.e., limit) this code describes how to relate the given value to a measured value, (e.g., a result should not be greater (not more) than the given value). The common accepted nomenclature should be used here.
D	C96079	Stability Study Type Terminology	C96108	Stability Study Type		Stability Study Type	This code classifies the type of study performed on the given Research Subject, e.g., Commercial, Development, Clinical.
D	C96080	Stability Container Closure System Terminology	C96112	Container Closure System		Closure System	The closure system of the container.
D	C96082	Stability Study Storage Condition Terminology	C96145	Storage Condition		Stability Study Storage Condition	The code provided represents a storage condition. Dependent of the internal company definitions this condition might be simple (e.g., 25 degrees) or complex (e.g., 25 degrees C/60% R.H. upright).
D	C96083	Stability Study Pause Description Terminology	C96149	Pause Description		Stability Study Pause Description	This code describes any delay that happened during testing, e.g. none (Immediate) or freeze sample (Delayed Frozen).
C	C96071	Stability Study Data File Reason Terminology	C70880	Premarket Approval		Premarket Approval	Stability data submitted for a PMA application.
C	C96074	Stability Product Form Terminology	C87539	Tag Dosage Form	A pharmaceutical dosage form containing active substance(s) that are delivered via a tag device.	TAG	
C	C96074	Stability Product Form Terminology	C87542	Pendant Dosage Form	A pharmaceutical dosage form containing active substance(s) delivered via pendant.	PENDANT