ambien cr

Generic: zolpidem tartrate

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ambien cr
Generic Name zolpidem tartrate
Labeler cosette pharmaceuticals, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

zolpidem tartrate 6.25 mg/1

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-5501
Product ID 0713-5501_2d9350bd-56ea-7273-e063-6394a90a0e61
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021774
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2025-02-07

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 07135501
Hyphenated Format 0713-5501

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
  • 6.25 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (0713-5501-01)
source: ndc

Packages (1)

0713-5501-01 100 TABLET, COATED in 1 BOTTLE (0713-5501-01)

Ingredients (1)

zolpidem tartrate (6.25 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": "2d9350bd-56ea-7273-e063-6394a90a0e61", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854880", "854882", "854894", "854896"], "spl_set_id": ["2d934da3-bd77-4470-e063-6294a90a64f5"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (0713-5501-01)", "package_ndc": "0713-5501-01", "marketing_start_date": "20250207"}], "brand_name": "Ambien CR", "product_id": "0713-5501_2d9350bd-56ea-7273-e063-6394a90a0e61", "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": "0713-5501", "dea_schedule": "CIV", "generic_name": "zolpidem tartrate", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ambien", "brand_name_suffix": "CR", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "6.25 mg/1"}], "application_number": "NDA021774", "marketing_category": "NDA", "marketing_start_date": "20250207", "listing_expiration_date": "20261231"}