FDA Orange Book
Generic for Amrix
Amrix 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 Amrix is cyclobenzaprine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Amrix products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 15MG | Marketed (Rx) | AB | 3 | AB |
| capsule, extended release, oral | 30MG | Marketed (Rx) | AB | 3 | AB |
NDA 021777, held by TEVA PHARMACEUTICALS INTERNATIONAL GMBH. 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 |
|---|---|---|---|---|
| TWI PHARMACEUTICALS INC | 091281 | AB (A-rated, therapeutically equivalent) | January 31, 2013 | 15MG, 30MG |
| MACLEODS PHARMACEUTICALS LTD | 207314 | AB (A-rated, therapeutically equivalent) | July 22, 2024 | 15MG, 30MG |
| NOVAST LABORATORIES LTD | 214732 | AB (A-rated, therapeutically equivalent) | August 27, 2024 | 15MG, 30MG |
Amrix NDC codes
Questions
Is there a generic for Amrix?
Yes. The generic name for Amrix is cyclobenzaprine. 3 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 Amrix?
The active ingredient in Amrix 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.