FDA Orange Book
Generic for Septra
Septra contains sulfamethoxazole and trimethoprim. 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 Septra is sulfamethoxazole and trimethoprim. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
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Septra products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 80MG/ML;16MG/ML | Discontinued | None | 2 | AP |
| suspension, oral | 200MG/5ML;40MG/5ML | Discontinued | None | 4 | AB |
| tablet, oral | 400MG;80MG | Discontinued | None | 6 | AB |
NDA 018452, 017598, 017376, held by MONARCH PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic sulfamethoxazole and trimethoprim
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES INC | 071017 | AB (A-rated, therapeutically equivalent) | August 25, 1986 | 400MG;80MG |
| TEVA PHARMACEUTICALS USA | 073303 | AP (A-rated, therapeutically equivalent) | October 31, 1991 | 80MG/ML;16MG/ML |
| AMNEAL PHARMACEUTICALS NY LLC | 076899 | AB (A-rated, therapeutically equivalent) | January 27, 2005 | 400MG;80MG |
| VISTA PHARMACEUTICALS INC | 076817 | AB (A-rated, therapeutically equivalent) | October 7, 2005 | 400MG;80MG |
| PRASCO LLC DBA PRASCO LABORATORIES | 077612 | AB (A-rated, therapeutically equivalent) | November 13, 2006 | 200MG/5ML;40MG/5ML |
| CHARTWELL MOLECULAR HOLDINGS LLC | 077785 | AB (A-rated, therapeutically equivalent) | January 24, 2007 | 200MG/5ML;40MG/5ML |
| CHARTWELL MOLECULES LLC | 078060 | AB (A-rated, therapeutically equivalent) | January 25, 2007 | 400MG;80MG |
| AUROBINDO PHARMA LTD | 090624 | AB (A-rated, therapeutically equivalent) | February 16, 2010 | 400MG;80MG |
| AUROBINDO PHARMA LTD | 091348 | AB (A-rated, therapeutically equivalent) | June 8, 2010 | 200MG/5ML;40MG/5ML |
| GLENMARK PHARMACEUTICALS LTD | 090828 | AB (A-rated, therapeutically equivalent) | December 22, 2010 | 400MG;80MG |
| SOMERSET THERAPEUTICS LLC | 212231 | AP (A-rated, therapeutically equivalent) | June 26, 2019 | 80MG/ML;16MG/ML |
| NOVITIUM PHARMA LLC | 214330 | AB (A-rated, therapeutically equivalent) | February 8, 2022 | 200MG/5ML;40MG/5ML |
Questions
Is there a generic for Septra?
Yes. The generic name for Septra is sulfamethoxazole and trimethoprim. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
What is the generic name for Septra?
The active ingredient in Septra is sulfamethoxazole and trimethoprim, 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.