zolpidem tartrate

Generic: zolpidem tartrate

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

zolpidem tartrate 5 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6082
Product ID 0904-6082_0f5acdac-482c-4150-b8e4-8488d4eee975
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077903
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2007-09-05

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 09046082
Hyphenated Format 0904-6082

Supplemental Identifiers

RxCUI
854873 854876
UPC
0309046083610
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 ANDA077903 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-6082-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6082-61 100 BLISTER PACK in 1 CARTON (0904-6082-61) / 1 TABLET in 1 BLISTER PACK

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": "0f5acdac-482c-4150-b8e4-8488d4eee975", "openfda": {"upc": ["0309046083610"], "unii": ["WY6W63843K"], "rxcui": ["854873", "854876"], "spl_set_id": ["d34336b1-7041-4078-beda-94bc9d9f771e"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6082-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-6082-61", "marketing_start_date": "20070905"}], "brand_name": "ZOLPIDEM TARTRATE", "product_id": "0904-6082_0f5acdac-482c-4150-b8e4-8488d4eee975", "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": "0904-6082", "dea_schedule": "CIV", "generic_name": "zolpidem tartrate", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZOLPIDEM TARTRATE", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "5 mg/1"}], "application_number": "ANDA077903", "marketing_category": "ANDA", "marketing_start_date": "20070905", "listing_expiration_date": "20261231"}