ambien

Generic: zolpidem tartrate

Labeler: sanofi-aventis u.s. llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ambien
Generic Name zolpidem tartrate
Labeler sanofi-aventis u.s. llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

zolpidem tartrate 10 mg/1

Manufacturer
Sanofi-Aventis U.S. LLC

Identifiers & Regulatory

Product NDC 0024-5421
Product ID 0024-5421_3d6feaca-4f30-4ca9-a9c8-d9038744fa2f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019908
DEA Schedule civ
Marketing Start 1993-04-01
Marketing End 2026-09-30

Pharmacologic Class

Classes
central nervous system depression [pe] gaba a receptor positive modulators [moa] gamma-aminobutyric acid a receptor positive modulator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00245421
Hyphenated Format 0024-5421

Supplemental Identifiers

RxCUI
854873 854875 854876 854878
UNII
WY6W63843K

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ambien (source: ndc)
Generic Name zolpidem tartrate (source: ndc)
Application Number NDA019908 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (0024-5421-31)
source: ndc

Packages (1)

0024-5421-31 100 TABLET, FILM COATED in 1 BOTTLE (0024-5421-31)

Ingredients (1)

zolpidem tartrate (10 mg/1)

Linked Drug Pages (1)

Ambien ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3d6feaca-4f30-4ca9-a9c8-d9038744fa2f", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854873", "854875", "854876", "854878"], "spl_set_id": ["c36cadf4-65a4-4466-b409-c82020b42452"], "manufacturer_name": ["Sanofi-Aventis U.S. LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0024-5421-31)", "package_ndc": "0024-5421-31", "marketing_end_date": "20260930", "marketing_start_date": "19930401"}], "brand_name": "Ambien", "product_id": "0024-5421_3d6feaca-4f30-4ca9-a9c8-d9038744fa2f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Receptor Positive Modulators [MoA]", "gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]"], "product_ndc": "0024-5421", "dea_schedule": "CIV", "generic_name": "zolpidem tartrate", "labeler_name": "Sanofi-Aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ambien", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "10 mg/1"}], "application_number": "NDA019908", "marketing_category": "NDA", "marketing_end_date": "20260930", "marketing_start_date": "19930401"}