ambien

Generic: zolpidem tartrate

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

Drug Facts

Product Profile

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

zolpidem tartrate 10 mg/1

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-5421
Product ID 0713-5421_2d934208-e709-2948-e063-6294a90aa9b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019908
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 07135421
Hyphenated Format 0713-5421

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 (0713-5421-01)
source: ndc

Packages (1)

0713-5421-01 100 TABLET, FILM COATED in 1 BOTTLE (0713-5421-01)

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": "2d934208-e709-2948-e063-6294a90aa9b6", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854873", "854875", "854876", "854878"], "spl_set_id": ["747949c5-2c91-4909-8a07-71b6826f8e97"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0713-5421-01)", "package_ndc": "0713-5421-01", "marketing_start_date": "20250207"}], "brand_name": "Ambien", "product_id": "0713-5421_2d934208-e709-2948-e063-6294a90aa9b6", "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": "0713-5421", "dea_schedule": "CIV", "generic_name": "zolpidem tartrate", "labeler_name": "Cosette Pharmaceuticals, Inc.", "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_start_date": "20250207", "listing_expiration_date": "20261231"}