FDA Orange Book

Generic for Lasix

Lasix contains furosemide. 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 Lasix is furosemide. 20 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.

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Lasix products in the Orange Book

Lasix products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
injectable, injection	10MG/ML	Discontinued	None	14	AP
solution, oral	10MG/ML	Discontinued	None	1	None
tablet, oral	20MG	Discontinued	None	5	AB
tablet, oral	40MG	Discontinued	None	5	AB
tablet, oral	80MG	Discontinued	None	6	AB

NDA 016363, 017688, 016273, held by SANOFI AVENTIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic furosemide

Approved generic versions of Lasix
Company	ANDA	TE code	Approved	Strengths
HIKMA PHARMACEUTICALS USA INC	070086	AB (A-rated, therapeutically equivalent)	January 24, 1986	80MG
ACCORD HEALTHCARE INC	070017	AP (A-rated, therapeutically equivalent)	December 15, 1986	10MG/ML
HIKMA PHARMACEUTICALS USA INC	070434	None (No TE code listed)	April 22, 1987	10MG/ML
HOSPIRA INC	075241	AP (A-rated, therapeutically equivalent)	May 28, 1999	10MG/ML
PRINSTON PHARMACEUTICAL INC	076796	AB (A-rated, therapeutically equivalent)	March 26, 2004	20MG, 40MG, 80MG
LEADING PHARMA LLC	077293	AB (A-rated, therapeutically equivalent)	November 9, 2005	20MG, 40MG, 80MG
IPCA LABORATORIES LTD	078010	AB (A-rated, therapeutically equivalent)	September 18, 2006	20MG, 40MG, 80MG
APOTEX INC	077941	AP (A-rated, therapeutically equivalent)	March 22, 2007	10MG/ML
BAXTER HEALTHCARE CORP	202747	AP (A-rated, therapeutically equivalent)	January 27, 2014	10MG/ML
AVET LIFESCIENCES LTD	203428	AP (A-rated, therapeutically equivalent)	August 26, 2014	10MG/ML
EUGIA PHARMA SPECIALITIES LTD	212174	AP (A-rated, therapeutically equivalent)	May 3, 2019	10MG/ML
GLAND PHARMA LTD	213902	AP (A-rated, therapeutically equivalent)	July 1, 2020	10MG/ML
AREVA PHARMACEUTICALS INC	208435	AP (A-rated, therapeutically equivalent)	December 18, 2020	10MG/ML
SAGENT PHARMACEUTICALS	214766	AP (A-rated, therapeutically equivalent)	January 27, 2021	10MG/ML
MEITHEAL PHARMACEUTICALS INC	212803	AP (A-rated, therapeutically equivalent)	January 27, 2022	10MG/ML
GRAVITI PHARMACEUTICALS PRIVATE LTD	216629	AB (A-rated, therapeutically equivalent)	October 17, 2022	20MG, 40MG, 80MG
MANKIND PHARMA LTD	216860	AP (A-rated, therapeutically equivalent)	December 16, 2022	10MG/ML
SABA ILAC SANAYIVE TICARET AS	215856	AP (A-rated, therapeutically equivalent)	April 2, 2024	10MG/ML
ASPIRO PHARMA LTD	217557	AP (A-rated, therapeutically equivalent)	December 13, 2024	10MG/ML
AUROBINDO PHARMA LTD	218831	AB (A-rated, therapeutically equivalent)	July 17, 2025	20MG, 40MG, 80MG
MICRO LABS LTD	218188	AP (A-rated, therapeutically equivalent)	January 8, 2026	10MG/ML

Lasix NDC codes

Questions

Is there a generic for Lasix?

Yes. The generic name for Lasix is furosemide. 20 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 Lasix?

The active ingredient in Lasix is furosemide, 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.