zolpidem tartrate

Generic: zolpidem tartrate

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler asclemed usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

zolpidem tartrate 5 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-416
Product ID 76420-416_3aa8cb56-eaef-625f-e063-6394a90a52ea
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 76420416
Hyphenated Format 76420-416

Supplemental Identifiers

RxCUI
854873 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
  • 1000 TABLET, FILM COATED in 1 BOTTLE (76420-416-00)
  • 100 TABLET, FILM COATED in 1 BOTTLE (76420-416-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (76420-416-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (76420-416-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (76420-416-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76420-416-90)
source: ndc

Packages (6)

76420-416-00 1000 TABLET, FILM COATED in 1 BOTTLE (76420-416-00) 76420-416-01 100 TABLET, FILM COATED in 1 BOTTLE (76420-416-01) 76420-416-05 500 TABLET, FILM COATED in 1 BOTTLE (76420-416-05) 76420-416-30 30 TABLET, FILM COATED in 1 BOTTLE (76420-416-30) 76420-416-60 60 TABLET, FILM COATED in 1 BOTTLE (76420-416-60) 76420-416-90 90 TABLET, FILM COATED in 1 BOTTLE (76420-416-90)

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": "3aa8cb56-eaef-625f-e063-6394a90a52ea", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854873", "854876"], "spl_set_id": ["9922ce14-b418-4235-9c59-d674a8e70210"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (76420-416-00)", "package_ndc": "76420-416-00", "marketing_start_date": "20250724"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (76420-416-01)", "package_ndc": "76420-416-01", "marketing_start_date": "20250724"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (76420-416-05)", "package_ndc": "76420-416-05", "marketing_start_date": "20250724"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76420-416-30)", "package_ndc": "76420-416-30", "marketing_start_date": "20250724"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (76420-416-60)", "package_ndc": "76420-416-60", "marketing_start_date": "20250724"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76420-416-90)", "package_ndc": "76420-416-90", "marketing_start_date": "20250724"}], "brand_name": "Zolpidem Tartrate", "product_id": "76420-416_3aa8cb56-eaef-625f-e063-6394a90a52ea", "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": "76420-416", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "Asclemed USA, Inc.", "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": "20070504", "listing_expiration_date": "20261231"}