FDA Orange Book

Generic for Celebrex

Celebrex contains celecoxib. 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 Celebrex is celecoxib. 18 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Celebrex products in the Orange Book

Celebrex products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
capsule, oral	100MG	Marketed (Rx)	AB	17	AB
capsule, oral	200MG	Marketed (Rx)	AB	18	AB
capsule, oral	400MG	Marketed (Rx)	AB	15	AB
capsule, oral	50MG	Marketed (Rx)	AB	17	AB

NDA 020998, held by UPJOHN US 2 LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic celecoxib

Approved generic versions of Celebrex
Company	ANDA	TE code	Approved	Strengths
TEVA PHARMACEUTICALS USA INC	076898	AB (A-rated, therapeutically equivalent)	May 30, 2014	100MG, 200MG, 400MG, 50MG
WATSON LABORATORIES INC	200562	AB (A-rated, therapeutically equivalent)	February 11, 2015	100MG, 200MG, 400MG, 50MG
APOTEX INC	204197	AB (A-rated, therapeutically equivalent)	June 2, 2015	100MG, 200MG, 50MG
LUPIN LTD	202240	AB (A-rated, therapeutically equivalent)	June 9, 2015	100MG, 200MG, 400MG, 50MG
ALEMBIC PHARMACEUTICALS LTD	204519	AB (A-rated, therapeutically equivalent)	August 21, 2015	100MG, 200MG, 400MG, 50MG
CIPLA LTD	207446	AB (A-rated, therapeutically equivalent)	September 23, 2015	100MG, 200MG, 400MG, 50MG
TORRENT PHARMACEUTICALS LTD	207677	AB (A-rated, therapeutically equivalent)	December 23, 2015	100MG, 200MG, 400MG, 50MG
AUROBINDO PHARMA LTD	206827	AB (A-rated, therapeutically equivalent)	February 1, 2016	100MG, 200MG, 400MG, 50MG
MACLEODS PHARMACEUTICALS LTD	204590	AB (A-rated, therapeutically equivalent)	March 16, 2016	100MG, 200MG, 400MG, 50MG
CSPC OUYI PHARMACEUTICAL CO LTD	210071	AB (A-rated, therapeutically equivalent)	January 23, 2018	100MG, 200MG, 50MG
MICRO LABS LTD	204776	AB (A-rated, therapeutically equivalent)	April 30, 2018	100MG, 200MG, 400MG, 50MG
QINGDAO BAHEAL PHARMACEUTICAL CO LTD	208856	AB (A-rated, therapeutically equivalent)	August 7, 2019	100MG, 200MG, 400MG, 50MG
CADILA PHARMACEUTICALS LTD	208701	AB (A-rated, therapeutically equivalent)	November 14, 2019	100MG, 200MG, 400MG, 50MG
PHARMAZONE	210628	AB (A-rated, therapeutically equivalent)	November 27, 2019	100MG, 200MG, 400MG, 50MG
TIANJIN TIANYAO PHARMACEUTICALS CO LTD	207872	AB (A-rated, therapeutically equivalent)	February 25, 2020	100MG, 200MG, 400MG, 50MG
PHARMOBEDIENT CONSULTING LLC	211412	AB (A-rated, therapeutically equivalent)	March 6, 2020	100MG, 200MG, 400MG, 50MG
NANJING SIMCERE DONGYUAN PHARMACEUTICAL CO LTD	213598	AB (A-rated, therapeutically equivalent)	May 13, 2020	200MG
SCIEGEN PHARMACEUTICALS INC	205129	AB (A-rated, therapeutically equivalent)	December 3, 2020	100MG, 200MG, 400MG, 50MG

Celebrex NDC codes

Questions

Is there a generic for Celebrex?

Yes. The generic name for Celebrex is celecoxib. 18 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 Celebrex?

The active ingredient in Celebrex is celecoxib, 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.