zolpidem tartrate

Generic: zolpidem tartrate

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

zolpidem tartrate 5 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-838
Product ID 60687-838_2035bfab-4917-0e91-e063-6294a90a7b22
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078413
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2024-09-01

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 60687838
Hyphenated Format 60687-838

Supplemental Identifiers

RxCUI
854876
UNII
WY6W63843K

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 zolpidem tartrate (source: ndc)
Generic Name zolpidem tartrate (source: ndc)
Application Number ANDA078413 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (60687-838-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-838-11)
source: ndc

Packages (1)

60687-838-01 100 BLISTER PACK in 1 CARTON (60687-838-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-838-11)

Ingredients (1)

zolpidem tartrate (5 mg/1)

Linked Drug Pages (1)

Zolpidem Tartrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2035bfab-4917-0e91-e063-6294a90a7b22", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854876"], "spl_set_id": ["eb850154-4b4b-4d9a-8476-aea1a93fe8d7"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (60687-838-01)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-838-11)", "package_ndc": "60687-838-01", "marketing_start_date": "20240901"}], "brand_name": "Zolpidem Tartrate", "product_id": "60687-838_2035bfab-4917-0e91-e063-6294a90a7b22", "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": "60687-838", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zolpidem Tartrate", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "5 mg/1"}], "application_number": "ANDA078413", "marketing_category": "ANDA", "marketing_start_date": "20240901", "listing_expiration_date": "20261231"}