The Orange Book
PLEASE NOTE: On January 25, 2017, The Orange Book reference standard and RLD data were updated - details here.
The publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act) and related patent and exclusivity information. For more information on the Orange Book including its history, see the Orange Book Preface.
Search approved drug products by active ingredient, proprietary name, applicant, application number, dosage form, route of administration or patent number.
Orange Book Publications
Orange Book Annual Edition(PDF - 8.4MB)
37th Edition - The publication identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act.
Orange Book Current Cumulative Supplement(PDF - 771KB)
The monthly Cumulative Supplement publication provides information on newly approved drugs, changes and revisions to current data including therapeutic equivalence evaluations, and updated patent and exclusivity data.
- Appendix A: Product Name Index (PDF - 185KB)
Prescription and OTC drug product lists. An index of drug products by established or trade name. Updated quarterly.
- Appendix B: Product Name Sorted by Applicant (PDF - 958KB)
Product Name Index listed by Applicant (prescription and OTC product lists). Cross-references applicants to drug products. Updated quarterly.
- Appendix C: Uniform Terms (PDF - 108KB)
Uniform terms used to designate dosage forms and routes of administration; abbreviations used to designate strengths.
Additions/Deletions for Prescription and OTC Drug Product Lists
Additions and deletions to the Prescription and OTC Drug Product Lists for a specific month
- Orange Book Data Files (compressed) (ZIP - 640KB)
Download the Orange Book Data files (updated monthly). For more information, including the descriptions of data fields in the Orange Book Search, see Orange Book Data Files.
Orange Book FR Safety or Effectiveness Determinations List
List of approved drug products that have had Federal Register Citizen Petition Notices stating that the FDA has determined that the approved drug product was not discontinued for safety or effectiveness reasons
Frequently Asked Questions on The Orange Book Frequently Asked Questions on Patents and Exclusivity Orange Book Preface
The Orange Book downloadable data files are updated monthly. We make every effort to prevent errors and discrepancies in the Approved Drug Products data files; however, if you wish to report an error or discrepancy in drug data, please send a brief description of the problem to firstname.lastname@example.org.
General questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information email@example.com.
Requests for more specific information should be submitted in writing or directed to the FDA's Freedom of Information (FOIA) Staff.