FDA Orange Book

Generic for Flagyl

Flagyl contains metronidazole. 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 Flagyl is metronidazole. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

Run it in Rivvi

Map Flagyl and your other top fills to their generics

Every strength in RxNorm, with brands that have no generic flagged.

Build the map

Free to start. Opens Rivvi, the AI workspace for healthcare teams.

Flagyl products in the Orange Book

Flagyl products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
capsule, oral	375MG	Marketed (Rx)	AB	2	AB
tablet, oral	250MG	Discontinued	None	11	AB
tablet, oral	500MG	Discontinued	None	11	AB

NDA 020334, 012623, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic metronidazole

Approved generic versions of Flagyl
Company	ANDA	TE code	Approved	Strengths
TEVA PHARMACEUTICALS USA INC	070027	AB (A-rated, therapeutically equivalent)	November 6, 1984	250MG
PLIVA INC	070033	AB (A-rated, therapeutically equivalent)	December 6, 1984	500MG
WATSON LABORATORIES INC	070035	AB (A-rated, therapeutically equivalent)	December 20, 1984	250MG
WATSON LABORATORIES INC	070044	AB (A-rated, therapeutically equivalent)	February 8, 1985	500MG
INNOGENIX LLC	070772	AB (A-rated, therapeutically equivalent)	July 16, 1986	250MG, 500MG
CHARTWELL RX SCIENCES LLC	076522	AB (A-rated, therapeutically equivalent)	January 29, 2004	375MG
ALEMBIC PHARMACEUTICALS LTD	079067	AB (A-rated, therapeutically equivalent)	March 13, 2009	250MG, 500MG
ALEMBIC PHARMACEUTICALS LTD	079065	AB (A-rated, therapeutically equivalent)	June 23, 2009	375MG
UNICHEM LABORATORIES LTD	203458	AB (A-rated, therapeutically equivalent)	January 22, 2014	250MG, 500MG
AUROBINDO PHARMA LTD	203974	AB (A-rated, therapeutically equivalent)	May 29, 2015	250MG, 500MG
SOMERSET THERAPEUTICS LLC	205245	AB (A-rated, therapeutically equivalent)	September 23, 2015	250MG, 500MG
NOVITIUM PHARMA LLC	208162	AB (A-rated, therapeutically equivalent)	May 25, 2016	250MG, 500MG
CADILA HEALTHCARE LTD	206560	AB (A-rated, therapeutically equivalent)	November 16, 2016	250MG, 500MG
ALEMBIC PHARMACEUTICALS LTD	208681	AB (A-rated, therapeutically equivalent)	June 20, 2017	250MG, 500MG
CADILA PHARMACEUTICALS LTD	209794	AB (A-rated, therapeutically equivalent)	December 12, 2017	250MG, 500MG

Flagyl NDC codes

0025-1942

Questions

Is there a generic for Flagyl?

Yes. The generic name for Flagyl is metronidazole. 12 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 Flagyl?

The active ingredient in Flagyl is metronidazole, 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.