FDA Orange Book

Generic for Chantix

Chantix contains varenicline. 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 Chantix is varenicline. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Chantix products in the Orange Book

Chantix products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	EQ 0.5MG BASE	Marketed (Rx)	AB	20	AB
tablet, oral	EQ 1MG BASE	Marketed (Rx)	AB	20	AB

NDA 021928, held by PF PRISM CV. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic varenicline

Approved generic versions of Chantix
Company	ANDA	TE code	Approved	Strengths
PH HEALTH LTD	201785	AB (A-rated, therapeutically equivalent)	August 11, 2021	EQ 0.5MG BASE, EQ 1MG BASE
APOTEX INC	201962	AB (A-rated, therapeutically equivalent)	January 25, 2023	EQ 0.5MG BASE, EQ 1MG BASE
ZYDUS WORLDWIDE DMCC	216723	AB (A-rated, therapeutically equivalent)	June 12, 2023	EQ 0.5MG BASE, EQ 1MG BASE
PHARMAZONE	217151	AB (A-rated, therapeutically equivalent)	July 25, 2023	EQ 0.5MG BASE, EQ 1MG BASE
MANKIND PHARMA LTD	214255	AB (A-rated, therapeutically equivalent)	August 1, 2023	EQ 0.5MG BASE, EQ 1MG BASE
ALKEM LABORATORIES LTD	214557	AB (A-rated, therapeutically equivalent)	August 23, 2023	EQ 0.5MG BASE, EQ 1MG BASE
HETERO LABS LTD UNIT III	214571	AB (A-rated, therapeutically equivalent)	October 23, 2023	EQ 0.5MG BASE, EQ 1MG BASE
LUPIN LTD	211862	AB (A-rated, therapeutically equivalent)	December 4, 2023	EQ 0.5MG BASE, EQ 1MG BASE
NE RX PHARMA LLC	217283	AB (A-rated, therapeutically equivalent)	March 6, 2024	EQ 0.5MG BASE, EQ 1MG BASE
AJANTA PHARMA LTD	213019	AB (A-rated, therapeutically equivalent)	March 19, 2024	EQ 0.5MG BASE, EQ 1MG BASE
PHARMAZONE	217115	AB (A-rated, therapeutically equivalent)	July 23, 2024	EQ 0.5MG BASE, EQ 1MG BASE
DR REDDYS LABORATORIES LTD	215931	AB (A-rated, therapeutically equivalent)	October 1, 2024	EQ 0.5MG BASE, EQ 1MG BASE
REGCON HOLDINGS LLC	219106	AB (A-rated, therapeutically equivalent)	October 29, 2024	EQ 0.5MG BASE, EQ 1MG BASE
MACLEODS PHARMACEUTICALS LTD	215048	AB (A-rated, therapeutically equivalent)	December 9, 2024	EQ 0.5MG BASE, EQ 1MG BASE
ADAPTIS PHARMA PRIVATE LTD	216615	AB (A-rated, therapeutically equivalent)	April 8, 2025	EQ 0.5MG BASE, EQ 1MG BASE
AUROBINDO PHARMA LTD	214595	AB (A-rated, therapeutically equivalent)	May 2, 2025	EQ 0.5MG BASE, EQ 1MG BASE
VIWIT PHARMACEUTICAL CO LTD	212879	AB (A-rated, therapeutically equivalent)	May 6, 2025	EQ 0.5MG BASE, EQ 1MG BASE
MICRO LABS LTD	218302	AB (A-rated, therapeutically equivalent)	October 29, 2025	EQ 0.5MG BASE, EQ 1MG BASE
UMEDICA LABORATORIES PRIVATE LTD	218985	AB (A-rated, therapeutically equivalent)	January 9, 2026	EQ 0.5MG BASE, EQ 1MG BASE
SOMERSET THERAPEUTICS LLC	219382	AB (A-rated, therapeutically equivalent)	July 6, 2026	EQ 0.5MG BASE, EQ 1MG BASE

Chantix NDC codes

Questions

Is there a generic for Chantix?

Yes. The generic name for Chantix is varenicline. 19 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 Chantix?

The active ingredient in Chantix is varenicline, 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.