zolpidem

Generic: zolpidem tartrate

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

Drug Facts

Product Profile

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

zolpidem tartrate 5 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0430
Product ID 80425-0430_1fa85237-6f77-fa21-e063-6294a90a1d75
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077214
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2024-08-13

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 804250430
Hyphenated Format 80425-0430

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 (source: ndc)
Generic Name zolpidem tartrate (source: ndc)
Application Number ANDA077214 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (80425-0430-1)
  • 60 TABLET in 1 BOTTLE (80425-0430-2)
  • 90 TABLET in 1 BOTTLE (80425-0430-3)
source: ndc

Packages (3)

80425-0430-1 30 TABLET in 1 BOTTLE (80425-0430-1) 80425-0430-2 60 TABLET in 1 BOTTLE (80425-0430-2) 80425-0430-3 90 TABLET in 1 BOTTLE (80425-0430-3)

Ingredients (1)

zolpidem tartrate (5 mg/1)

Linked Drug Pages (1)

Zolpidem ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1fa85237-6f77-fa21-e063-6294a90a1d75", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854876"], "spl_set_id": ["1fa86b79-8809-35f4-e063-6394a90a4377"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (80425-0430-1)", "package_ndc": "80425-0430-1", "marketing_start_date": "20240813"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (80425-0430-2)", "package_ndc": "80425-0430-2", "marketing_start_date": "20240813"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (80425-0430-3)", "package_ndc": "80425-0430-3", "marketing_start_date": "20240813"}], "brand_name": "Zolpidem", "product_id": "80425-0430_1fa85237-6f77-fa21-e063-6294a90a1d75", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Receptor Positive Modulators [MoA]", "gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]"], "product_ndc": "80425-0430", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zolpidem", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "5 mg/1"}], "application_number": "ANDA077214", "marketing_category": "ANDA", "marketing_start_date": "20240813", "listing_expiration_date": "20261231"}