What the FDA Orange Book contains and how to search it online

What the FDA Orange Book contains and how to search it

The FDA Orange Book, officially "Approved Drug Products with Therapeutic Equivalence Evaluations", is the US FDA list of drug products approved on the basis of safety and effectiveness, with their therapeutic equivalence (TE) codes and related patent and exclusivity information (FDA). The search is free. You can search the Electronic Orange Book, the FDA Orange Book database, by brand name, active ingredient, application number, company, dosage form, route or patent number, or download the monthly data files.

What is the Orange Book?

FDA's Center for Drug Evaluation and Research (CDER) maintains the list. FDA first published it in October 1980 (Orange Book preface). Section 505(j)(7) of the FD&C Act requires FDA to publish the list and to issue monthly supplements (preface). Under 21 CFR 314.3, listed-drug status is evidenced by the drug product's identification in the current edition as an approved drug.

The current print edition is the 46th edition (2026). FDA adds a Cumulative Supplement each month. The latest one at the time of writing is Supplement 9, September 2026.

What the Orange Book contains

The annual edition is arranged in six parts (preface). The discontinued list is still part of the book.

• Prescription Drug Product List
• OTC Drug Product List
• Drug Products with Approval under Section 505 of the Act Administered by CBER
• Discontinued Drug Product List
• Patent and Exclusivity Addendum
• Appendices A to C

A product entry shows the active ingredient, dosage form and route, strength, proprietary name and applicant. It also shows the application number and product number, TE code, approval date, marketing status (RX, OTC or discontinued) and the RLD and RS flags (Electronic Orange Book).

Tentatively approved products are not listed. Some unapproved products are left out too, including large-volume IV products in glass (preface). On March 23, 2020, biological products approved under section 505 were deemed to be biologics license applications and removed from the Orange Book (FDA). Licensed biological products are in the Purple Book.

How to search the Electronic Orange Book

The Electronic Orange Book search page lists six options.

• proprietary name, active ingredient or application number (one search box)
• applicant (company)
• dosage form
• route of administration
• patent number
• newly added or delisted patents

Start with a brand name, an ingredient or an application number. Then match strength, dosage form and route before you use a TE code or a reference-drug flag.

A product is identified by application type, application number and product number. N means a new drug application (NDA). A means an abbreviated new drug application (ANDA). In the data files, application numbers are zero-padded, so NDA 19630 is stored as 019630.

The live search is the one to use for a new approval. New generic approvals have been added daily since February 2005, and patent information also changes daily, generally on business days. Exclusivity information is updated monthly (Cumulative Supplement, FDA). On October 20, 2026 the search page read "Current through October 2026".

Orange Book data files and PDF

For bulk work, FDA publishes Orange Book data files as a ZIP of Products.txt, Patent.txt and Exclusivity.txt. The files are ASCII text with tilde (~) delimiters, and FDA updates them monthly, though the ZIP can lag the live search. A patent added this week may be missing from the file you just downloaded. If you want an Orange Book PDF, use the annual edition or the monthly cumulative supplement.

Reference listed drug and reference standard

For an ANDA, read both columns. 21 CFR 314.3 defines them. The reference listed drug (RLD) is "the listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its ANDA." The reference standard (RS) is "the drug product selected by FDA that an applicant seeking approval of an ANDA must use in conducting an in vivo bioequivalence study required for approval."

FDA ordinarily selects the RLD as the RS, though the two can differ, and the Orange Book marks them in separate RLD and RS columns (preface). Don't treat an RLD flag as the RS flag. Check both before you pick the comparator for a required in vivo bioequivalence study. FDA explains the difference in Referencing Approved Drug Products in ANDA Submissions.

Orange Book codes and ratings

The TE code is the Orange Book rating. Under 21 CFR 314.3, therapeutic equivalents are approved drug products that are pharmaceutical equivalents, have demonstrated bioequivalence, and can be expected to have the same clinical effect and safety profile under the conditions in the labeling.

An A code means FDA considers the product therapeutically equivalent (preface). AA, AN, AO, AP and AT mean no known or suspected bioequivalence problems. AB means actual or potential problems were resolved with adequate evidence. AB is not the only equivalence code. If several reference listed drugs share an ingredient and dosage form, FDA uses numbered codes such as AB1 and AB2. Only products with the same code are equivalent to each other.

B codes mean FDA does not currently consider the products therapeutically equivalent. BX means the data are insufficient. Pharmacists use TE codes as a reference when checking generic substitution, but state law decides whether a substitution is allowed, so check your state's rules. On August 24, 2026, FDA announced the final guidance Evaluation of Therapeutic Equivalence, which finalizes the July 2022 draft (Federal Register).

Patent and exclusivity listings

The Orange Book includes patent and exclusivity information. The Orange Book Transparency Act limits patent listings to drug substance, drug product and method-of-use patents. It also requires FDA to list exclusivity periods that have not expired. NDA holders must tell FDA within 14 days of a final PTAB or court decision invalidating a listed patent claim, and FDA then removes that claim from the listing. NDA holders submit information on those patents under 21 CFR 314.53. Process patents, packaging patents, metabolite patents and intermediate patents must not be submitted. A blank patent field doesn't prove that no patent exists. Disputed listings are on FDA's patent listing dispute list.

RegAffairs AI's cited answer covers the Orange Book, application number searches and RLDs.