Electronic Animal Drug Product Listing Directory
Updated nightly on business days
What is the Electronic Animal Drug Product Listing Directory?
The Electronic Animal Drug Product Listing Directory is a directory of all animal drug products that have been listed electronically since June 1, 2009, to comply with changes enacted as part of the FDA Amendments Act of 2007.
FDA makes every effort to prevent errors and discrepancies in the Directory data. Users who detect any errors are requested to contact:
Food and Drug Administration
Center for Veterinary Medicine
Communications Staff, HFV-12
7519 Standish Place
Rockville, MD 20855
Internet email: AskCVM@fda.hhs.gov
What products are included in the Electronic Animal Drug Product Listing Directory?
All animal drug products listed electronically since June 1, 2009, are included in the directory. These include animal products that have been manufactured, prepared, propagated, compounded, or processed by registered establishments for commercial distribution. The products have been listed in accordance with the Act and regulatory provisions concerning the submission of drug product information to FDA.
THE INCLUSION OF A FIRM OR ITS PRODUCTS IN THE ELECTRONIC ANIMAL DRUG PRODUCT LISTING DIRECTORY DOES NOT DENOTE APPROVAL BY THE FDA OF THE FIRM OR ANY OF ITS MARKETED PRODUCTS, NOR IS IT A DETERMINATION THAT A PRODUCT IS A DRUG AS DEFINED BY THE ACT.
How is the Electronic Animal Drug Product Listing Directory Organized?
1. National Drug Code (NDC) Number
Each animal drug product electronically listed is assigned a unique 10-digit, 3-segment number. This number, known as the NDC, identifies the labeler code, product code, and package code. The first segment, the labeler code, is assigned by the FDA. A labeler is defined as any firm that distributes or markets the drug product. The second segment, the product code, identifies a specific strength, dosage form, and formulation of the product. The third segment, the package code, identifies package sizes and types. Both the product and package codes are assigned by the firm.
An asterisk may appear in either a product code or a package code. It simply acts as a place holder and indicates the configuration of the NDC number. The NDC is limited to 10 digits, a firm with a 5 digit labeler code must choose between a 3 digit product code and 2 digit package code, or a 4 digit product code and 1 digit package code. A firm with a 4 digit labeler code must choose a 4 digit product code and 2 digit package code.
2. Proprietary Name (Trade Name)
The Proprietary Names used in the Electronic Animal Drug Product Listing Directory are generally supplied by the firms as required under the Act. All product names appearing in the Directory are limited to a maximum of 100 characters. Symbols indicating trademarked or registered products are omitted because of computer input capabilities. But these deletions are not intended to contradict patent, trademark, registration, or copyright laws or regulations.
3. Non Proprietary Name (Established Name)
The Non Proprietary Names used in the Electronic Animal Drug Product Listing Directory are supplied by the firms as required under the Act. Non proprietary names are also known as established names.
4. Labeler Name
The Labeler Name is the name associated with the labeler code portion of the NDC number and represents the distributor marketing the product.
5. Product Type
The Product Type refers to the general category of products being listed. For animal drugs, the following product types are available:
PRESCRIPTION ANIMAL DRUG
OTC ANIMAL DRUG
OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG
OTC TYPE B MEDICATED FEED ANIMAL DRUG
OTC TYPE C MEDICATED FEED ANIMAL DRUG
VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG
VFD TYPE B MEDICATED FEED ANIMAL DRUG
VFD TYPE C MEDICATED FEED ANIMAL DRUG
6. Marketing Category
The Marketing Category lists whether the drug product is the subject of an approved New Animal Drug Application (NADA), an Abbreviated New Animal Drug Application (ANADA), a listing in the Index of Legally Marketed New Animal Drugs for Minor Species (Index listing), or an Unapproved animal drug (UNAPPROVED OTHER).
7. Application Number
The Application Number field contains either:
1) the NADA or ANADA number, which signifies that this product has been approved by FDA for marketing based on a review of the safety and effectiveness of the drug, including review of a) whether adequate and well-controlled investigations show that this drug is safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling; b) the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of this drug and whether they adequately preserve the drug’s identity, strength, quality, and purity; and c) the drug’s proposed labeling. For additional information regarding NADA and ANADA approval, see section 512 of the Act, 21 U.S.C. § 360b; or
2) the Minor species Index File (MIF) number, which signifies that this product has been listed in the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species based on a review of the safety and effectiveness of the drug, including a) an initial review of food, environmental, and user safety; b) a subsequent review of target animal safety and effectiveness by a panel of recognized experts; c) a determination of the manufacturer’s knowledge of, and commitment to assure manufacture in compliance with, current good manufacturing practices; and a review of the drug’s proposed labeling. For additional information regarding Index listing, see section 572 of the Act, 21 U.S.C. § 360ccc-1, and 21 CFR part 516 subpart C.
Blanks in this field signify that listing for a product did not include an approved application NADA or ANADA number or an Index listing MIF number. Such a product may not have been approved or index listed for safety and efficacy by FDA, or the data may have been omitted for some reason.
The Link field provides a link to the Structured Product Labeling (SPL) information associated with each animal drug product listed electronically.