FDA Orange Book
Generic for Ambien CR
Ambien CR 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 CR is zolpidem. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Ambien CR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 12.5MG | Marketed (Rx) | AB | 4 | AB |
| tablet, extended release, oral | 6.25MG | Marketed (Rx) | AB | 4 | AB |
NDA 021774, 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
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 090107 | AB (A-rated, therapeutically equivalent) | July 1, 2011 | 12.5MG, 6.25MG |
| LUPIN LTD | 078970 | AB (A-rated, therapeutically equivalent) | September 11, 2013 | 12.5MG, 6.25MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 204170 | AB (A-rated, therapeutically equivalent) | January 24, 2017 | 12.5MG, 6.25MG |
| BRECKENRIDGE PHARMACEUTICAL INC | 213592 | AB (A-rated, therapeutically equivalent) | June 4, 2020 | 12.5MG, 6.25MG |
Ambien CR NDC codes
Questions
Is there a generic for Ambien CR?
Yes. The generic name for Ambien CR is zolpidem. 4 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 CR?
The active ingredient in Ambien CR 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.