Generic for Bactrim: Sulfamethoxazole and Trimethoprim

Yes. The generic name for Bactrim 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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Bactrim products in the Orange Book

Bactrim products and approved generics
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	Marketed (Rx)	AB	6	AB

NDA 018374, 017560, 017377, held by SUN PHARMACEUTICAL INDUSTRIES 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

Approved generic versions of Bactrim
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

Bactrim NDC codes

Questions

Is there a generic for Bactrim?

Yes. The generic name for Bactrim 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 Bactrim?

The active ingredient in Bactrim 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.

Generic for Bactrim