Is Ambien CR still available?

Yes. Ambien CR (NDA 021774) is listed with marketing status Prescription in the FDA Orange Book.

Does Ambien CR have a generic?

Yes. The Orange Book lists 36 approved generic (ANDA) applications sharing Ambien CR's active ingredient (Zolpidem Tartrate). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What does Ambien CR's TE code AB mean?

AB is an "A"-rated therapeutic-equivalence code, meaning the FDA considers Ambien CR substitutable for its reference brand with no expected difference in clinical effect.

What is Ambien CR's FDA application number?

Ambien CR is approved under NDA 021774, held by Cosette.

Orange Book product · Brand (NDA)

Ambien CR

Zolpidem Tartrate

Brand (NDA)NDA 021774TE ABRLD Cosette

Approved

Sep 02, 2005

Application

Brand (NDA)

TE code

Listed patents

Ambien CR (Zolpidem Tartrate) is Cosette's brand-name drug, approved by the FDA under NDA 021774 in 2005. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its therapeutic-equivalence code is AB, so the FDA considers it substitutable for the reference brand. 36 approved generics share this drug's active ingredient.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Sep 02, 2005
21 yr 2 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

ZOLPIDEM TARTRATE

Strength

6.25MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Application

NDA 021774

Product number

002

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Same application

Other strengths in NDA 021774

12.5MGTABLET, EXTENDED RELEASE

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Zolpidem Tartrate family

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Ambien CR — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Zolpidem Tartrate active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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