FDA Orange Book

Generic for Sulfatrim

Sulfatrim 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 Sulfatrim is sulfamethoxazole and trimethoprim. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Sulfatrim products in the Orange Book

Sulfatrim products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
suspension, oral	200MG/5ML;40MG/5ML	Discontinued	None	4	AB

NDA 018615, held by PHARMACEUTICAL ASSOCIATES 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 Sulfatrim
Company	ANDA	TE code	Approved	Strengths
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
AUROBINDO PHARMA LTD	091348	AB (A-rated, therapeutically equivalent)	June 8, 2010	200MG/5ML;40MG/5ML
NOVITIUM PHARMA LLC	214330	AB (A-rated, therapeutically equivalent)	February 8, 2022	200MG/5ML;40MG/5ML

Sulfatrim NDC codes

Questions

Is there a generic for Sulfatrim?

Yes. The generic name for Sulfatrim is sulfamethoxazole and trimethoprim. 4 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 Sulfatrim?

The active ingredient in Sulfatrim 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.