`
`Drug Approvals and Databases > Inactive Ingredient Field Descriptions
`
`Inactive Ingredient Field Descriptions
`Inactive Ingredient Field Descriptions
`
`Inactive Ingredient
`An inactive ingredient is any component of a drug product other than the active ingredient. Only inactive ingredients in the final dosage forms of drug
`products are included in this database.
`
`Route
`A route of administration is a way of administering a drug to a site in a patient. A comprehensive list of specific routes of administration appears in the
`Data Standards Manual.
`(/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/DataStandardsManualmonographs/default.htm)
`
`Dosage Form
`A dosage form is a form in which a drug is produced and dispensed. A comprehensive list of specific routes of administration appears in the Data
`Standards Manual
`(/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/DataStandardsManualmonographs/default.htm).
`
`CAS Number
`The acronym "CAS" stands for "Chemical Abstracts Service," a division of the American Chemical Society that provides comprehensive electronic
`chemical information services. CAS assigns unique CAS Registry Numbers to chemical substances. Many inactive ingredients have CAS Registry
`Numbers, which are useful in searching other databases for chemical information. The CAS Registry Number itself has no chemical significance.
`
`UNII
`The acronym “UNII” stands for “Unique Ingredient Identifier”
`
`The UNII is a part of the joint USP/FDA Substance Registration System (SRS), which has been designed to support health information technology
`initiatives by providing unique identifiers for substances in drugs, biologics, foods, and devices based on molecular structure and/or descriptive
`information. The SRS is used to generate permanent, unique, unambiguous identifiers for substances in regulated products, such as ingredients in drug
`products.
`
`More information about the UNII and the SRS is available on the Data Council SRS page
`(/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/default.htm). All chemically-related questions about
`the UNII or the SRS that are not answered on the FDA website should be directed fda-srs@fda.hhs.gov (mailto:fda-srs@fda.hhs.gov).
`
`Potency Amount
`The "potency amount" field specifies the maximum amount of inactive ingredient for each route/dosage form containing that ingredient. When there is no
`calculable potency measurement for the inactive ingredient, the "potency amount" field will be blank.
`
`Potency Unit
`The "potency unit" field specifes the unit type associated with the potency amount. This field may be blank.
`
`Resources for You
`
`Inactive Ingredient Search for Approved Drug Products: Frequently Asked Questions (/Drugs/InformationOnDrugs/ucm080123.htm)
`Inactive Ingredients Database Download (/Drugs/InformationOnDrugs/ucm113978.htm)
`
`More in Drug Approvals and Databases
`(/Drugs/InformationOnDrugs/default.htm)
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`https://www.fda.gov/Drugs/InformationOnDrugs/ucm075230.htm
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`AMN1054
`Amneal v. Almirall, LLC
`IPR2018-00608
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`1
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`1/24/2019
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`Drug Approvals and Databases > Inactive Ingredient Field Descriptions
`
`Approved Drugs (/Drugs/InformationOnDrugs/ApprovedDrugs/default.htm)
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