Generic for Valium: Diazepam

Yes. The generic name for Valium is diazepam. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Valium products the Orange Book lists.

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Valium products in the Orange Book

Valium products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
injectable, injection	5MG/ML	Discontinued	None	0	None
tablet, oral	10MG	Marketed (Rx)	AB	5	AB
tablet, oral	2MG	Marketed (Rx)	AB	5	AB
tablet, oral	5MG	Marketed (Rx)	AB	5	AB

NDA 016087, 013263, held by HOFFMANN LA ROCHE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic diazepam

Approved generic versions of Valium
Company	ANDA	TE code	Approved	Strengths
MYLAN PHARMACEUTICALS INC	070325	AB (A-rated, therapeutically equivalent)	September 4, 1985	10MG, 2MG, 5MG
NUVO PHARMACEUTICAL INC	070464	AB (A-rated, therapeutically equivalent)	February 25, 1986	10MG, 2MG, 5MG
IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA	071322	AB (A-rated, therapeutically equivalent)	December 10, 1986	10MG
IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA	071307	AB (A-rated, therapeutically equivalent)	December 10, 1986	2MG
IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA	071321	AB (A-rated, therapeutically equivalent)	December 10, 1986	5MG
DR REDDYS LABORATORIES SA	071136	AB (A-rated, therapeutically equivalent)	February 3, 1987	10MG
DR REDDYS LABORATORIES SA	071134	AB (A-rated, therapeutically equivalent)	February 3, 1987	2MG
DR REDDYS LABORATORIES SA	071135	AB (A-rated, therapeutically equivalent)	February 3, 1987	5MG
AUROBINDO PHARMA LTD	217843	AB (A-rated, therapeutically equivalent)	December 14, 2023	10MG, 2MG, 5MG

Valium NDC codes

Questions

Is there a generic for Valium?

Yes. The generic name for Valium is diazepam. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Valium products the Orange Book lists.

What is the generic name for Valium?

The active ingredient in Valium is diazepam, 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.

Generic for Valium