zolpidem tartrate

Generic: zolpidem tartrate

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

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

zolpidem tartrate 12.5 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-862
Product ID 63187-862_16ffd293-15a1-4014-9b06-6772decd7651
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021774
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2010-12-06

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 63187862
Hyphenated Format 63187-862

Supplemental Identifiers

RxCUI
854880
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 NDA021774 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-15)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-30)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-60)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-90)
source: ndc

Packages (4)

63187-862-15 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-15) 63187-862-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-30) 63187-862-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-60) 63187-862-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-90)

Ingredients (1)

zolpidem tartrate (12.5 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": "16ffd293-15a1-4014-9b06-6772decd7651", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854880"], "spl_set_id": ["facfc337-3447-4052-a9aa-8aa55282a3e3"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-15)", "package_ndc": "63187-862-15", "marketing_start_date": "20170601"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-30)", "package_ndc": "63187-862-30", "marketing_start_date": "20170601"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-60)", "package_ndc": "63187-862-60", "marketing_start_date": "20170601"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-862-90)", "package_ndc": "63187-862-90", "marketing_start_date": "20170601"}], "brand_name": "Zolpidem Tartrate", "product_id": "63187-862_16ffd293-15a1-4014-9b06-6772decd7651", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Agonists [MoA]", "Pyridines [CS]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "63187-862", "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": "12.5 mg/1"}], "application_number": "NDA021774", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20101206", "listing_expiration_date": "20261231"}