1/6/2019
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`Drug Approvals and Databases > Inactive Ingredient Search for Approved Drug Products: Frequently Asked Questions
`
`Inactive Ingredient Search for Approved
`Drug Products: Frequently Asked
`Questions
`
`Most recent changes to the database (/Drugs/InformationOnDrugs/ucm567080.htm) (updated 7/14/2017)
`Search the Inactive Ingredient Database (http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm)
`
`About the Inactive Ingredient Database
`1. What is an inactive ingredient?
`2. What is an active ingredient?
`3. What is the purpose of the Inactive Ingredient Database?
`4. How do you use the Inactive Ingredient Database?
`5. What is maximum potency?
`6. Can an inactive ingredient ever be considered an active ingredient?
`7. Does the Inactive Ingredient Database include contaminants found in approved drug products?
`8. What is a CAS Number?
`9. What is a UNII?
`10. How often do you update the Inactive Ingredient Database?
`11. How can I get a copy of the Inactive Ingredient Database?
`
` 1. What is an inactive ingredient?
`
`According to 21 CFR 210.3(b)(8), 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 in this database.
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`2. What is an active ingredient?
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`According to 21 CFR 210.3(b)(7), an active ingredient is any component of a drug product intended to furnish
`pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease,
`or to affect the structure or any function of the body of humans or other animals. Active ingredients include those
`components of the product that may undergo chemical change during the manufacture of the drug product and be
`present in the drug product in a modified form intended to furnish the specified activity or effect.
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`https://www.fda.gov/drugs/informationondrugs/ucm080123.htm
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`Drug Approvals and Databases > Inactive Ingredient Search for Approved Drug Products: Frequently Asked Questions
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`3. What is the purpose of the Inactive Ingredient Database?
`
`The Inactive Ingredient Database provides information on inactive ingredients present in FDA-approved drug
`products. This information can be used by industry as an aid in developing drug products. For new drug
`development purposes, once an inactive ingredient has appeared in an approved drug product for a particular route
`of administration, the inactive ingredient is not considered new and may require a less extensive review the next
`time it is included in a new drug product. For example, if a particular inactive ingredient has been approved in a
`certain dosage form at a certain potency, a sponsor could consider it safe for use in a similar manner for a similar
`type of product.
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`4. How do you use the Inactive Ingredient Database?
`
`You can search the Inactive Ingredient Database by entering any portion of the name of an inactive ingredient. You
`must enter at least three characters. Search results are displayed alphabetically, sorted first by ingredient, then by
`the route of administration and dosage form. Routes of administration and dosage forms are derived from current
`approved labeling.
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`Field Descriptions (/Drugs/InformationOnDrugs/ucm075230.htm)
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`5. What is maximum potency?
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`Maximum potency is the amount of the excipient used in the approved product that is the basis for the IID listing.
`The IID lists the highest amount of the excipient per unit dose in each dosage form in which it is used. The amounts
`shown for maximum potency do not reflect the maximum daily intake (MDI) of the excipient unless the maximum
`daily dose of the product that is the basis for the listing is only a single unit. For topical products and other products
`where excipients are expressed as a percentage of the product formula, maximum potency is the highest formula
`percentage. Maximum potency of an excipient is a dynamic value that changes when FDA approves products with
`new, higher levels of the excipient. After approval, these new maximum potencies will appear in the next publication
`of the IID.
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`6. Can an inactive ingredient ever be considered an active ingredient?
`
`The Inactive Ingredient Database contains inactive ingredients specifically intended as such by the manufacturer.
`Inactive ingredients can also be considered active ingredients under certain circumstances, according to the
`definition of an active ingredient given in 21 CFR 210.3(b)(7). Alcohol is a good example of an ingredient that
`may be considered either active or inactive depending on the product formulation.
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`Reactants in radiopharmaceutical kits, or inactive ingredients that physically or chemically combine with active
`ingredients to facilitate drug transport are considered inactive ingredients.
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`7. Does the Inactive Ingredient Database include contaminants found in approved drug products?
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`No. The Inactive Ingredients Database does not include contaminants found in approved drug products.
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`8. What is a CAS Number?
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`Drug Approvals and Databases > Inactive Ingredient Search for Approved Drug Products: Frequently Asked Questions
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`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.
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`9. What is a UNII?
`
`The acronym “UNII” stands for “Unique Ingredient Identifier”. The UNII is a part of the joint United States
`Pharmacopeia (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. The
`UNII is being displayed in association with inactive ingredients to facilitate Structured Product Labeling
`(http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm) (SPL), which
`requires that a UNII be used for all ingredients, including inactive ingredients.
`
`Not all inactive ingredients will have a UNII. In order to receive a UNII, an ingredient must be a ‘substance’, which is
`defined as “Any physical material that has a discrete existence, irrespective of origin.” Products will not be assigned
`a UNII. For example, “purified water” and “sterile water for injection” are considered products within the context of
`the SRS because something is done to the substance “water” in order to make it more useful. Proprietary
`ingredients, such as “OPADRY II 85F10919 BLUE”, are considered products and will not be assigned a UNII. Such
`products are denoted by "N/A".
`
`More information about the UNII and the SRS is available at Substance Registration System - Unique
`Ingredient Identifier (UNII) (http://www.fda.gov/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).
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`10. How often do you update the Inactive Ingredient Database?
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`We update the database quarterly, by the tenth working day of April, July, October, and January.
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`11. How can I get a copy of the Inactive Ingredient Database?
`
`You can download the contents of the Inactive Ingredient Database. The Inactive Ingredient Database Download
`(/Drugs/InformationOnDrugs/ucm113978.htm) are provided as delimited text and Excel files.
`
`Text files since 2009 are provided in order to track previous changes.
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`Data field descriptions (/Drugs/InformationOnDrugs/ucm075230.htm)
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`Inactive Ingredient Database Help and Information files
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`https://www.fda.gov/drugs/informationondrugs/ucm080123.htm
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`Drug Approvals and Databases > Inactive Ingredient Search for Approved Drug Products: Frequently Asked Questions
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`Inactive Ingredients Database Help, Instruction, and Download files
`
`Inactive Ingredient Field Descriptions (/Drugs/InformationOnDrugs/ucm075230.htm)
`Inactive Ingredient Database Download (/Drugs/InformationOnDrugs/ucm113978.htm)
`
`Resources for You
`
`Structured Product Labeling Resources (/ForIndustry/DataStandards/StructuredProductLabeling/default.htm)
`Substance Registration System - Unique Ingredient Identifier (UNII)
`(/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/default.htm)
`CDER FOIA Electronic Reading Room
`(/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/default.htm)
`Inactive Ingredients Database Download (/Drugs/InformationOnDrugs/ucm113978.htm)
`
`More in Drug Approvals and Databases
`(/Drugs/InformationOnDrugs/default.htm)
`
`Approved Drugs (/Drugs/InformationOnDrugs/ApprovedDrugs/default.htm)
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