FDA Orange Book
Generic for Soma
Soma contains carisoprodol. 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 Soma is carisoprodol. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB. Generics match 2 of the 3 Soma products the Orange Book lists.
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Soma products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 250MG | Discontinued | None | 0 | None |
| tablet, oral | 250MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | 350MG | Marketed (Rx) | AA | 13 | AA |
NDA 011792, held by MYLAN SPECIALTY LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic carisoprodol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WATSON LABORATORIES INC | 087499 | AA (A-rated, therapeutically equivalent) | April 20, 1982 | 350MG |
| PHARMAZONE | 081025 | AA (A-rated, therapeutically equivalent) | April 13, 1989 | 350MG |
| OXFORD PHARMACEUTICALS LLC | 040188 | AA (A-rated, therapeutically equivalent) | March 7, 1997 | 350MG |
| CHARTWELL RX SCIENCES LLC | 040245 | AA (A-rated, therapeutically equivalent) | September 8, 1997 | 350MG |
| ACCELRX LABS LLC | 040576 | AA (A-rated, therapeutically equivalent) | June 7, 2005 | 350MG |
| INGENUS PHARMACEUTICALS LLC | 040823 | AA (A-rated, therapeutically equivalent) | October 22, 2008 | 350MG |
| SCIEGEN PHARMACEUTICALS INC | 203374 | AA (A-rated, therapeutically equivalent) | January 27, 2014 | 350MG |
| NATCO PHARMA LTD | 090988 | AA (A-rated, therapeutically equivalent) | October 28, 2014 | 350MG |
| ORIENT PHARMA CO LTD | 205085 | AA (A-rated, therapeutically equivalent) | October 28, 2014 | 350MG |
| HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | 205126 | AB (A-rated, therapeutically equivalent) | July 8, 2015 | 250MG, 350MG |
| AUROBINDO PHARMA LTD | 040792 | AB (A-rated, therapeutically equivalent) | November 8, 2016 | 250MG, 350MG |
| MPP PHARMA LLC | 207237 | AB (A-rated, therapeutically equivalent) | May 11, 2017 | 250MG, 350MG |
| PHARMAZONE | 211789 | AA (A-rated, therapeutically equivalent) | October 20, 2021 | 350MG |
Soma NDC codes
Questions
Is there a generic for Soma?
Yes. The generic name for Soma is carisoprodol. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB. Generics match 2 of the 3 Soma products the Orange Book lists.
What is the generic name for Soma?
The active ingredient in Soma is carisoprodol, 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.
More on Soma and Carisoprodol
- What is Soma used for?FDA label uses
- Is Soma a controlled substance?Schedule IV
- What is Carisoprodol used for?FDA label uses
- Is Carisoprodol a controlled substance?Schedule IV
- Generic for RelaFDA Orange Book
- Muscle Relaxants listFDA drug class
- NDC 0037-2001Soma NDC record
- NDC 0037-2250Soma NDC record
- Schedule IV drugs listDEA schedule