FDA Orange Book
Generic for Flexeril
Flexeril contains cyclobenzaprine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Flexeril is cyclobenzaprine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Flexeril and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Flexeril products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Discontinued | None | 13 | AB |
| tablet, oral | 5MG | Discontinued | None | 13 | AB |
NDA 017821, held by JANSSEN RESEARCH AND DEVELOPMENT LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic cyclobenzaprine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS LABORATORIES FL INC | 071611 | AB (A-rated, therapeutically equivalent) | May 3, 1989 | 10MG, 5MG |
| AIPING PHARMACEUTICAL INC | 072854 | AB (A-rated, therapeutically equivalent) | November 19, 1991 | 10MG, 5MG |
| TP ANDA HOLDINGS LLC | 073541 | AB (A-rated, therapeutically equivalent) | May 23, 1995 | 10MG, 5MG |
| TP ANDA HOLDINGS LLC | 077209 | AB (A-rated, therapeutically equivalent) | October 4, 2005 | 10MG, 5MG |
| JUBILANT CADISTA PHARMACEUTICALS INC | 077563 | AB (A-rated, therapeutically equivalent) | April 19, 2006 | 10MG, 5MG |
| PRINSTON PHARMACEUTICAL INC | 077797 | AB (A-rated, therapeutically equivalent) | February 28, 2007 | 10MG, 5MG |
| CHARTWELL RX SCIENCES LLC | 078218 | AB (A-rated, therapeutically equivalent) | April 18, 2008 | 10MG, 5MG |
| AUROBINDO PHARMA LTD | 078643 | AB (A-rated, therapeutically equivalent) | September 26, 2008 | 10MG, 5MG |
| INVAGEN PHARMACEUTICALS INC | 090478 | AB (A-rated, therapeutically equivalent) | July 23, 2010 | 10MG, 5MG |
| KVK TECH INC | 078048 | AB (A-rated, therapeutically equivalent) | February 28, 2011 | 10MG, 5MG |
| RUBICON RESEARCH LTD | 208170 | AB (A-rated, therapeutically equivalent) | May 31, 2017 | 10MG, 5MG |
| UNICHEM LABORATORIES LTD | 213324 | AB (A-rated, therapeutically equivalent) | July 5, 2020 | 10MG, 5MG |
| RISING PHARMA HOLDINGS INC | 218936 | AB (A-rated, therapeutically equivalent) | September 12, 2024 | 10MG, 5MG |
Questions
Is there a generic for Flexeril?
Yes. The generic name for Flexeril is cyclobenzaprine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Flexeril?
The active ingredient in Flexeril is cyclobenzaprine, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.