FDA Orange Book

Generic for Ambien

Ambien contains zolpidem. 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 Ambien is zolpidem. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Ambien products in the Orange Book

Ambien products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	10MG	Marketed (Rx)	AB	5	AB
tablet, oral	5MG	Marketed (Rx)	AB	5	AB

NDA 019908, held by COSETTE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic zolpidem

Approved generic versions of Ambien
Company	ANDA	TE code	Approved	Strengths
PHARMAZONE	077214	AB (A-rated, therapeutically equivalent)	April 23, 2007	10MG, 5MG
SANDOZ INC	077322	AB (A-rated, therapeutically equivalent)	April 23, 2007	10MG, 5MG
AUROBINDO PHARMA LTD	078413	AB (A-rated, therapeutically equivalent)	May 4, 2007	10MG, 5MG
TORRENT PHARMACEUTICALS LTD	077903	AB (A-rated, therapeutically equivalent)	August 17, 2007	10MG, 5MG
CHARTWELL MOLECULAR HOLDINGS LLC	077388	AB (A-rated, therapeutically equivalent)	July 30, 2012	10MG, 5MG

Ambien NDC codes

Questions

Is there a generic for Ambien?

Yes. The generic name for Ambien is zolpidem. 5 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 Ambien?

The active ingredient in Ambien is zolpidem, 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.