zolpidem tartrate

Generic: zolpidem tartrate

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

zolpidem tartrate 10 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-682
Product ID 63187-682_1d5b9b11-cb94-486d-9780-aca61a75c076
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076410
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2007-04-23

Pharmacologic Class

Classes
central nervous system depression [pe] gaba a agonists [moa] pyridines [cs] gamma-aminobutyric acid-ergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187682
Hyphenated Format 63187-682

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 ANDA076410 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (63187-682-15)
  • 30 TABLET, FILM COATED in 1 BOTTLE (63187-682-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (63187-682-60)
source: ndc

Packages (3)

63187-682-15 15 TABLET, FILM COATED in 1 BOTTLE (63187-682-15) 63187-682-30 30 TABLET, FILM COATED in 1 BOTTLE (63187-682-30) 63187-682-60 60 TABLET, FILM COATED in 1 BOTTLE (63187-682-60)

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": "1d5b9b11-cb94-486d-9780-aca61a75c076", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854873"], "spl_set_id": ["e534b3ac-1110-465f-8692-6ea585996fb6"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (63187-682-15)", "package_ndc": "63187-682-15", "marketing_start_date": "20160401"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63187-682-30)", "package_ndc": "63187-682-30", "marketing_start_date": "20160401"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63187-682-60)", "package_ndc": "63187-682-60", "marketing_start_date": "20160401"}], "brand_name": "Zolpidem Tartrate", "product_id": "63187-682_1d5b9b11-cb94-486d-9780-aca61a75c076", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Agonists [MoA]", "Pyridines [CS]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "63187-682", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zolpidem Tartrate", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "10 mg/1"}], "application_number": "ANDA076410", "marketing_category": "ANDA", "marketing_start_date": "20070423", "listing_expiration_date": "20261231"}