Generic Drugs - Specific Labeling Resources
Who Is the Audience for This Website?
FDA’s generic drug-specific labeling resources are primarily directed to industry staff who develop generic drug labeling. For more information about:
- Other prescription drug labeling resources for industry such as those for the Prescribing Information, FDA-approved patient labeling, carton and container labeling, biological product labeling, labeling databases, and product databases visit FDA’s Labeling Resources for Human Prescription Drugs.
- Drug labeling resources for healthcare professionals, patients, and caregivers, visit Frequently Asked Questions about Labeling for Prescription Medicines
Generic Drug Labeling
Generic drug labeling [labeling under an abbreviated new drug application (ANDA)] must be the “same as” the last approved reference listed drug (RLD) labeling except for permissible differences (e.g., manufacturer/packer/distributor information, package size, inactive ingredients, omission of information protected by patent or exclusivity, differences due to an approved suitability petition).
Updating Generic Drug Labeling
ANDA holders are expected to promptly update their generic drug labeling (ANDA labeling) after FDA has approved changes to the associated RLD labeling. Prompt revision, submission to the FDA, and implementation of revised ANDA labeling are important to ensure that the generic drug continues to be as safe and effective as the corresponding RLD.
ANDA holders should routinely review the last approved RLD labeling on Drugs@FDA to ensure that their ANDA labeling meets the “same as” requirements. For email updates about RLD labeling supplement approvals, subscribe to CDER Drug Safety Labeling Changes. ANDA holders can also obtain the last approved RLD labeling from FDA’s Division of Freedom of Information via online request, fax (301-827-9267), or mail (FDA Division of Freedom of Information Office of the Executive Secretariat, OC 5630 Fishers Lane, Room 1035 Rockville, MD 20857).
Labeling for certain ANDAs associated with a withdrawn reference listed drug (RLD) may be updated under the MODERN Labeling Act of 2020 when updating the ANDA labeling would benefit the public health and:
- There is new scientific evidence available pertaining to the existing conditions of use that is not reflected in the labeling
- The approved labeling does not reflect current legal and regulatory requirements for content or format; or
- There is a relevant accepted use in clinical practice that is not reflected in the approved labeling
Generic Drug-Specific Labeling Legislation/Regulations
- MODERN Labeling Act of 2020
- Section 505(j)(2)(A)(v) of the FD&C Act and 21 CFR 314.94(a)(8)(iv).
Generic Drug-Specific Labeling Guidances and MAPP
- Acceptability of Draft Labeling to Support ANDA Approval (final guidance)
- Determining Whether to Submit an ANDA or a 505(b)(2) Application (final guidance)
- Generic Drug Labeling Revisions Under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic Act MAPP (MAPP 5230.3 Revision 1)
- Good ANDA Submission Practices (draft guidance)
- Orange Book Questions and Answers (final guidance)
- Referencing Approved Drug Products in ANDA Submissions (final guidance)
- Revising ANDA Labeling Following Revision of the RLD Labeling (draft guidance)
- Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs (final guidance)
- Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn (draft guidance)
Other Generic Drug-Specific Labeling Resources
- FDA’s List of Established Drug Names Recommended to Use Tall Man Lettering
- Orange Book is a searchable online database containing FDA-approved drugs with therapeutic equivalence evaluations on the basis of safety and effectiveness under the Federal Food, Drug, and Cosmetic Act and related patent and exclusivity information.
- United States Pharmacopeia General Chapter <7> (Labeling) provides definitions and labeling standards for official USP articles including strength expression for injectable products, pharmacy bulk packages, imaging bulk packages, labeling for ferrules and cap overseals, aluminum use in parenteral nutrition, and expiration and beyond the use date.
For specific application or supplement questions or for general questions about prescription drug labeling, please visit Prescription Drug Labeling Contact Information.