zolpidem tartrate

Generic: zolpidem tartrate

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler bryant ranch prepack
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

zolpidem tartrate 12.5 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-4597
Product ID 63629-4597_56db3e80-5b7e-4611-92c7-88ed80f4e657
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090107
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2011-10-31

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 636294597
Hyphenated Format 63629-4597

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 ANDA090107 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-1)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-2)
  • 28 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-3)
  • 8 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-4)
  • 18 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-5)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-6)
source: ndc

Packages (6)

63629-4597-1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-1) 63629-4597-2 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-2) 63629-4597-3 28 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-3) 63629-4597-4 8 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-4) 63629-4597-5 18 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-5) 63629-4597-6 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-6)

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": "56db3e80-5b7e-4611-92c7-88ed80f4e657", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854880"], "spl_set_id": ["ce301d8b-0a8c-4404-8697-57222ae17a44"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-1)", "package_ndc": "63629-4597-1", "marketing_start_date": "20120829"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-2)", "package_ndc": "63629-4597-2", "marketing_start_date": "20151116"}, {"sample": false, "description": "28 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-3)", "package_ndc": "63629-4597-3", "marketing_start_date": "20240905"}, {"sample": false, "description": "8 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-4)", "package_ndc": "63629-4597-4", "marketing_start_date": "20240905"}, {"sample": false, "description": "18 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-5)", "package_ndc": "63629-4597-5", "marketing_start_date": "20240905"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-4597-6)", "package_ndc": "63629-4597-6", "marketing_start_date": "20240905"}], "brand_name": "Zolpidem tartrate", "product_id": "63629-4597_56db3e80-5b7e-4611-92c7-88ed80f4e657", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Receptor Positive Modulators [MoA]", "gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]"], "product_ndc": "63629-4597", "dea_schedule": "CIV", "generic_name": "Zolpidem tartrate", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zolpidem tartrate", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "12.5 mg/1"}], "application_number": "ANDA090107", "marketing_category": "ANDA", "marketing_start_date": "20111031", "listing_expiration_date": "20261231"}