FDA Orange Book

Generic for Ibu

Ibu contains ibuprofen. 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 Ibu is ibuprofen. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Ibu products in the Orange Book

Ibu products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
suspension, oral	100MG/5ML	Discontinued	None	5	AB
tablet, oral	400MG	Discontinued	None	12	AB

NDA 019784, 018197, held by ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic ibuprofen

Approved generic versions of Ibu
Company	ANDA	TE code	Approved	Strengths
CONTRACT PHARMACAL CORP	071268	AB (A-rated, therapeutically equivalent)	October 15, 1986	400MG
AMNEAL PHARMACEUTICALS NY LLC	071334	AB (A-rated, therapeutically equivalent)	November 25, 1986	400MG
ACTAVIS MID ATLANTIC LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC	074978	AB (A-rated, therapeutically equivalent)	March 25, 1998	100MG/5ML
DR REDDYS LABORATORIES INC	076112	AB (A-rated, therapeutically equivalent)	October 31, 2001	400MG
DR REDDYS LABORATORIES INC	075682	AB (A-rated, therapeutically equivalent)	November 14, 2001	400MG
PADAGIS US LLC	076925	AB (A-rated, therapeutically equivalent)	September 23, 2004	100MG/5ML
AMNEAL PHARMACEUTICALS NY LLC	078558	AB (A-rated, therapeutically equivalent)	June 18, 2007	400MG
STRIDES PHARMA GLOBAL PTE LTD	078329	AB (A-rated, therapeutically equivalent)	February 5, 2009	400MG
PHARMAZONE	090796	AB (A-rated, therapeutically equivalent)	December 21, 2010	400MG
GRANULES INDIA LTD	091625	AB (A-rated, therapeutically equivalent)	September 15, 2015	400MG
SHANDONG XINHUA PHARMACEUTICAL CO LTD	202413	AB (A-rated, therapeutically equivalent)	November 23, 2016	400MG
SUN PHARMA CANADA INC	209204	AB (A-rated, therapeutically equivalent)	June 23, 2017	100MG/5ML
AUROBINDO PHARMA LTD	209178	AB (A-rated, therapeutically equivalent)	February 16, 2018	100MG/5ML
AUROBINDO PHARMA LTD	213794	AB (A-rated, therapeutically equivalent)	May 8, 2020	400MG
ALKEM LABORATORIES LTD	214699	AB (A-rated, therapeutically equivalent)	September 13, 2021	400MG
YICHANG HUMANWELL PHARMACEUTICAL CO LTD	215318	AB (A-rated, therapeutically equivalent)	March 30, 2022	400MG
STRIDES PHARMA GLOBAL PTE LTD	215311	AB (A-rated, therapeutically equivalent)	May 27, 2022	100MG/5ML

Questions

Is there a generic for Ibu?

Yes. The generic name for Ibu is ibuprofen. 13 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 Ibu?

The active ingredient in Ibu is ibuprofen, 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.