zolpidem

Generic: zolpidem tartrate

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

Drug Facts

Product Profile

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

zolpidem tartrate 5 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-9613
Product ID 63629-9613_e5e05dd8-d19e-4562-9ea1-f02b02ea6407
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077214
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2020-09-24

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 636299613
Hyphenated Format 63629-9613

Supplemental Identifiers

RxCUI
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 (source: ndc)
Generic Name zolpidem tartrate (source: ndc)
Application Number ANDA077214 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (63629-9613-1)
source: ndc

Packages (1)

63629-9613-1 1000 TABLET in 1 BOTTLE (63629-9613-1)

Ingredients (1)

zolpidem tartrate (5 mg/1)

Linked Drug Pages (1)

Zolpidem ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e5e05dd8-d19e-4562-9ea1-f02b02ea6407", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854876"], "spl_set_id": ["70d7cfc3-7e54-4cd8-8911-7cf115d5c820"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (63629-9613-1)", "package_ndc": "63629-9613-1", "marketing_start_date": "20230203"}], "brand_name": "Zolpidem", "product_id": "63629-9613_e5e05dd8-d19e-4562-9ea1-f02b02ea6407", "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": "63629-9613", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zolpidem", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "5 mg/1"}], "application_number": "ANDA077214", "marketing_category": "ANDA", "marketing_start_date": "20200924", "listing_expiration_date": "20261231"}