Drugs
Inactive Ingredient Search for Approved Drug Products: Frequently Asked Questions
Database provides ability to search for inactive ingredients in approved drug products.
About the Inactive Ingredients Database
- What is an inactive ingredient?
- What is an active ingredient?
- What is the purpose of the Inactive Ingredients Database?
- How do you use the Inactive Ingredients Database?
- What if I can't find a particular ingredient?
- Can an inactive ingredient ever be considered an active ingredient?
- Does the Inactive Ingredients Database include contaminants found in approved drug products?
- What is a CAS Number?
- What is a UNII?
- How often do you update the Inactive Ingredients Database?
- How can I get further assistance?
- How can I get a copy of the Inactive Ingredients 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.
2. What is an active ingredient?
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.
3. What is the purpose of the Inactive Ingredients Database?
The Inactive Ingredients 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.
4. How do you use the Inactive Ingredients Database?
You can search the Inactive Ingredients 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.
5. What if I can't find a particular inactive ingredient?
Mail questions concerning inactive ingredients to:
Office of Generic Drugs
Regulatory Support Branch HFD-615
7500 Standish Place
Rockville MD 20855
Fax to: 240-276-8440
6. Can an inactive ingredient ever be considered an active ingredient?
The Inactive Ingredients 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.
Reactants in radiopharmaceutical kits, or inactive ingredients that physically or chemically combine with active ingredients to facilitate drug transport are considered inactive ingredients.
7. Does the Inactive Ingredients Database include contaminants found in approved drug products?
No. The Inactive Ingredients Database does not include contaminants found in approved drug products.
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.
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 (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). 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.
10. How often do you update the Inactive Ingredients Database?
We update the database quarterly, by the tenth working day of April, July, October, and January.
11. How can I get further assistance?
Due to an overwhelming response, we are no longer accepting Inactive Ingredient related questions via drugproducts@cder.fda.gov. We have been inundated with requests and do not have the resources to adequately respond to questions in a timely manner. If you have previously sent in requests, you may expect a response within sixty days. Correspondence, in reference to the IIG, should be sent to the Office of Generic Drugs via U.S.P.S or other form of mail delivery service. You will receive a response no later than 120 days after the document is received. As of July 2004, please send IIG correspondence to:
Office of Generic Drugs
Attention: Control Correspondence (IIG)
MPN II/HFD-600
7500 Standish Place
Rockville, MD 20855
12. How can I get a copy of the Inactive Ingredients Database?
You can download the contents of the Inactive Ingredients Database. Inactive Ingredients Database Download is a tilde (~) delimited text file. Allow for approximately 650KB for the unzip process.
Text files since 2009 are provided in order to track previous changes.
Refer to the IIG query search results column headers for data field definitions.
Inactive Ingredients Database Help and Information files
Inactive Ingredients Database Help, Instruction, and Download files
