Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
Did you ever wonder how the Orange Book got its nickname?
When the first print edition of Approved Drug Products with Therapeutic Equivalence Evaluations was being prepared October 1980, staff members in the Office of Generic Drugs had to choose a color for the cover. The project manager suggested, "It's almost Halloween. How about orange?"
Before long, The Orange Book had become a popular short title for this important publication.
About the Orange Book
The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, 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). (For more information, see the Orange Book Preface.)
The Approved Drug Products list first appeared as a print publication in 1980. With the 25th edition (2005), Portable Document Format (PDF) versions of the Annual Edition and the Cumulative Supplement became available.
The Orange Book Search was added to the FDA website October 31, 1997.
To send comments or questions about the Orange Book or drug data, please see the contact information below.
- Orange Book Search
You can search by active ingredient, proprietary name, applicant, or application number.
Orange Book Publications
Orange Book Annual Edition(PDF - 7.3MB)
35th 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 - 940KB)
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.
Additions/Deletions for Prescription and OTC Drug Product Lists
Changes to the annual edition are listed separately by month.
- About the Orange Book Data Files
Descriptions of data fields in the Web version of the Orange Book.
- Orange Book Data Files (compressed) (ZIP - 600KB)
Download the file. Updated monthly.
- Appendix A: Product Name Index (PDF - 172KB)
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 - 507KB)
Product Name Index Listed by Applicant (prescription and OTC product lists). Cross-references applicants to drug products. Updated quarterly.
- Appendix C: Uniform Terms (PDF - 58KB)
Uniform terms used to designate dosage forms and routes of administration; abbreviations used to designate strengths.
Help and Background Information
- Electronic Orange Book Video
FDA Drug Info Rounds pharmacists discuss how to search the Electronic Orange Book for generic equivalents, patents, and exclusivity. 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: DRUGPRODUCTS@CDER.FDA.GOV.
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: DRUGINFO@FDA.HHS.GOV.
Requests for more specific information should be submitted in writing or directed to the FDA's Freedom of Information (FOIA) Staff.
All FOIA requests must be in writing. At this time, FDA does not accept FOIA requests sent via e-mail. Requests should be mailed to the following address:
Food and Drug Administration
Division of Freedom of Information
Office of Shared Services
Office of Public Information and Library Services
12420 Parklawn Drive
Rockville, MD 20857
Requests may be sent via fax to: fax number (301) 827-9267.
If you experience difficulty sending a fax, please call (301) 796-3900.
The CDER Freedom of Information Office Electronic Reading Room page provides background information about the FOIA process.