Ambien (zolpidem tartrate) NDC 0024-5421

NDC codes

FDA NDC Directory

Product NDC (as listed)0024-5421Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00024-5421Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0024-5421-31	00024542131	100 TABLET, FILM COATED in 1 BOTTLE (0024-5421-31)Marketed from Apr 1, 1993

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Ambien
Generic name (nonproprietary): zolpidem tartrate
Active ingredients: Zolpidem tartrate — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Sanofi-Aventis U.S. LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 019908
Marketing start: Apr 1, 1993
Marketing end: Sep 30, 2026
DEA schedule: CIV
Other FDA classes: Central Nervous System Depression (Physiologic effect)GABA A Receptor Positive Modulators (Mechanism)
Identifiers: Product ID 0024-5421_3d6feaca-4f30-4ca9-a9c8-d9038744fa2fSPL ID 3d6feaca-4f30-4ca9-a9c8-d9038744fa2fSPL set ID c36cadf4-65a4-4466-b409-c82020b42452RxCUI 854873, 854875, 854876, 854878UNII WY6W63843K
Pharmacologic class: gamma-Aminobutyric Acid A Receptor Positive Modulator

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400024542131 followed by a unit qualifier and the quantity

Package 00024-5421-31. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Apr 15, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

AMBIEN (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. AMBIEN has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14) ] . The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. AMBIEN, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 019908

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 019908
Product	Strength	Form · route	Labeler	Product NDC
Ambienzolpidem tartrate	Zolpidem tartrate 10 mg/1	Tablet, Film coatedOral	Cosette Pharmaceuticals, Inc.	0713-5421
Ambienzolpidem tartrate	Zolpidem tartrate 5 mg/1	Tablet, Film coatedOral	Sanofi-Aventis U.S. LLC	0024-5401
Ambienzolpidem tartrate	Zolpidem tartrate 5 mg/1	Tablet, Film coatedOral	Cosette Pharmaceuticals, Inc.	0713-5401