zolpidem tartrate

Generic: zolpidem tartrate

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler advanced rx of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

zolpidem tartrate 10 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0061
Product ID 80425-0061_2a98ff70-0363-7169-e063-6394a90adc74
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078413
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2007-05-04

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 804250061
Hyphenated Format 80425-0061

Supplemental Identifiers

RxCUI
854873
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
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (80425-0061-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (80425-0061-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (80425-0061-3)
source: ndc

Packages (3)

80425-0061-1 30 TABLET, FILM COATED in 1 BOTTLE (80425-0061-1) 80425-0061-2 60 TABLET, FILM COATED in 1 BOTTLE (80425-0061-2) 80425-0061-3 90 TABLET, FILM COATED in 1 BOTTLE (80425-0061-3)

Ingredients (1)

zolpidem tartrate (10 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": "2a98ff70-0363-7169-e063-6394a90adc74", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854873"], "spl_set_id": ["af87df4e-2c97-e23e-e053-2a95a90ab354"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0061-1)", "package_ndc": "80425-0061-1", "marketing_start_date": "20070504"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0061-2)", "package_ndc": "80425-0061-2", "marketing_start_date": "20070504"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (80425-0061-3)", "package_ndc": "80425-0061-3", "marketing_start_date": "20070504"}], "brand_name": "Zolpidem Tartrate", "product_id": "80425-0061_2a98ff70-0363-7169-e063-6394a90adc74", "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": "80425-0061", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zolpidem Tartrate", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "10 mg/1"}], "application_number": "ANDA078413", "marketing_category": "ANDA", "marketing_start_date": "20070504", "listing_expiration_date": "20261231"}