FDA Orange Book

Generic for Exforge

Exforge contains amlodipine and valsartan. 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 Exforge is amlodipine and valsartan. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Exforge products in the Orange Book

Exforge products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	EQ 10MG BASE;160MG	Marketed (Rx)	AB	7	AB
tablet, oral	EQ 10MG BASE;320MG	Marketed (Rx)	AB	7	AB
tablet, oral	EQ 5MG BASE;160MG	Marketed (Rx)	AB	7	AB
tablet, oral	EQ 5MG BASE;320MG	Marketed (Rx)	AB	7	AB

NDA 021990, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic amlodipine and valsartan

Approved generic versions of Exforge
Company	ANDA	TE code	Approved	Strengths
STRIDES PHARMA INTERNATIONAL AG	090011	AB (A-rated, therapeutically equivalent)	March 28, 2013	EQ 10MG BASE;160MG, EQ 10MG BASE;320MG, EQ 5MG BASE;160MG, EQ 5MG BASE;320MG
MYLAN PHARMACEUTICALS INC	090483	AB (A-rated, therapeutically equivalent)	March 30, 2015	EQ 10MG BASE;160MG, EQ 10MG BASE;320MG, EQ 5MG BASE;160MG, EQ 5MG BASE;320MG
NOVEL LABORATORIES INC	202829	AB (A-rated, therapeutically equivalent)	March 30, 2015	EQ 10MG BASE;160MG, EQ 10MG BASE;320MG, EQ 5MG BASE;160MG, EQ 5MG BASE;320MG
ALEMBIC PHARMACEUTICALS LTD	202713	AB (A-rated, therapeutically equivalent)	April 3, 2015	EQ 10MG BASE;160MG, EQ 10MG BASE;320MG, EQ 5MG BASE;160MG, EQ 5MG BASE;320MG
AUROBINDO PHARMA LTD	206512	AB (A-rated, therapeutically equivalent)	April 22, 2016	EQ 10MG BASE;160MG, EQ 10MG BASE;320MG, EQ 5MG BASE;160MG, EQ 5MG BASE;320MG
HETERO LABS LTD	205137	AB (A-rated, therapeutically equivalent)	September 16, 2016	EQ 10MG BASE;160MG, EQ 10MG BASE;320MG, EQ 5MG BASE;160MG, EQ 5MG BASE;320MG
MACLEODS PHARMACEUTICALS LTD	207292	AB (A-rated, therapeutically equivalent)	October 11, 2024	EQ 10MG BASE;160MG, EQ 10MG BASE;320MG, EQ 5MG BASE;160MG, EQ 5MG BASE;320MG

Exforge NDC codes

Questions

Is there a generic for Exforge?

Yes. The generic name for Exforge is amlodipine and valsartan. 7 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 Exforge?

The active ingredient in Exforge is amlodipine and valsartan, 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.