FDA Orange Book
Generic for Robaxin
Robaxin contains methocarbamol. 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 Robaxin is methocarbamol. 17 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AP.
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Robaxin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, im-iv | 1GM/10ML (100MG/ML) | Marketed (Rx) | AP | 8 | AP |
| tablet, oral | 500MG | Discontinued | None | 9 | AA |
NDA 011790, 011011, held by HIKMA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic methocarbamol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| OXFORD PHARMACEUTICALS LLC | 040489 | AA (A-rated, therapeutically equivalent) | January 29, 2003 | 500MG |
| HETERO LABS LTD UNIT III | 090200 | AA (A-rated, therapeutically equivalent) | November 6, 2009 | 500MG |
| BOSTAL LLC | 200958 | AA (A-rated, therapeutically equivalent) | October 21, 2011 | 500MG |
| EUGIA PHARMA SPECIALITIES LTD | 206128 | AP (A-rated, therapeutically equivalent) | May 27, 2016 | 1GM/10ML (100MG/ML) |
| MONTEREY PHARMACEUTICALS LLC | 205354 | AP (A-rated, therapeutically equivalent) | October 27, 2016 | 1GM/10ML (100MG/ML) |
| HAINAN POLY PHARM CO LTD | 208116 | AP (A-rated, therapeutically equivalent) | January 19, 2017 | 1GM/10ML (100MG/ML) |
| PHARMOBEDIENT CONSULTING LLC | 203550 | AA (A-rated, therapeutically equivalent) | February 8, 2017 | 500MG |
| AMERICAN REGENT INC | 207496 | AP (A-rated, therapeutically equivalent) | June 22, 2017 | 1GM/10ML (100MG/ML) |
| SAGENT PHARMACEUTICALS INC | 205404 | AP (A-rated, therapeutically equivalent) | July 18, 2017 | 1GM/10ML (100MG/ML) |
| REGCON HOLDINGS LLC | 208507 | AA (A-rated, therapeutically equivalent) | July 21, 2017 | 500MG |
| SOMERSET THERAPEUTICS LLC | 207522 | AP (A-rated, therapeutically equivalent) | July 31, 2017 | 1GM/10ML (100MG/ML) |
| FRESENIUS KABI USA LLC | 209331 | AP (A-rated, therapeutically equivalent) | April 17, 2018 | 1GM/10ML (100MG/ML) |
| GRANULES INDIA LTD | 209312 | AA (A-rated, therapeutically equivalent) | May 7, 2018 | 500MG |
| GLAND PHARMA LTD | 211504 | AP (A-rated, therapeutically equivalent) | October 26, 2018 | 1GM/10ML (100MG/ML) |
| PHARMAZONE | 212623 | AA (A-rated, therapeutically equivalent) | April 30, 2021 | 500MG |
| AUROBINDO PHARMA LTD | 213967 | AA (A-rated, therapeutically equivalent) | February 9, 2023 | 500MG |
| PRINSTON PHARMACEUTICAL INC | 086988 | AA (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 500MG |
Robaxin NDC codes
Questions
Is there a generic for Robaxin?
Yes. The generic name for Robaxin is methocarbamol. 17 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AP.
What is the generic name for Robaxin?
The active ingredient in Robaxin is methocarbamol, 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.