ambien cr

Generic: zolpidem tartrate

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

Drug Facts

Product Profile

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

zolpidem tartrate 12.5 mg/1

Manufacturer
Sanofi-Aventis U.S. LLC

Identifiers & Regulatory

Product NDC 0024-5521
Product ID 0024-5521_3781baee-63d5-40a7-bc44-fc72d1adca32
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021774
DEA Schedule civ
Marketing Start 2005-09-19
Marketing End 2026-07-31

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 00245521
Hyphenated Format 0024-5521

Supplemental Identifiers

RxCUI
854880 854882 854894 854896
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 cr (source: ndc)
Generic Name zolpidem tartrate (source: ndc)
Application Number NDA021774 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (0024-5521-31)
source: ndc

Packages (1)

0024-5521-31 100 TABLET, COATED in 1 BOTTLE (0024-5521-31)

Ingredients (1)

zolpidem tartrate (12.5 mg/1)

Linked Drug Pages (1)

Ambien CR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3781baee-63d5-40a7-bc44-fc72d1adca32", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854880", "854882", "854894", "854896"], "spl_set_id": ["404c858c-89ac-4c9d-8a96-8702a28e6e76"], "manufacturer_name": ["Sanofi-Aventis U.S. LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (0024-5521-31)", "package_ndc": "0024-5521-31", "marketing_end_date": "20260731", "marketing_start_date": "20050919"}], "brand_name": "Ambien CR", "product_id": "0024-5521_3781baee-63d5-40a7-bc44-fc72d1adca32", "dosage_form": "TABLET, COATED", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Receptor Positive Modulators [MoA]", "gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]"], "product_ndc": "0024-5521", "dea_schedule": "CIV", "generic_name": "zolpidem tartrate", "labeler_name": "Sanofi-Aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ambien", "brand_name_suffix": "CR", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "12.5 mg/1"}], "application_number": "NDA021774", "marketing_category": "NDA", "marketing_end_date": "20260731", "marketing_start_date": "20050919"}