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, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

zolpidem tartrate 12.5 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1468
Product ID 71335-1468_8fc3132f-7766-4459-8ad9-bfc7e998f9bd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204170
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2017-05-15

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 713351468
Hyphenated Format 71335-1468

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 ANDA204170 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-1)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-2)
  • 28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-3)
  • 8 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-4)
  • 18 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-5)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-6)
source: ndc

Packages (6)

71335-1468-1 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-1) 71335-1468-2 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-2) 71335-1468-3 28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-3) 71335-1468-4 8 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-4) 71335-1468-5 18 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-5) 71335-1468-6 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-6)

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": "8fc3132f-7766-4459-8ad9-bfc7e998f9bd", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854880"], "spl_set_id": ["90201886-86a5-4c59-a4f1-98270d620731"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-1)", "package_ndc": "71335-1468-1", "marketing_start_date": "20200109"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-2)", "package_ndc": "71335-1468-2", "marketing_start_date": "20220512"}, {"sample": false, "description": "28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-3)", "package_ndc": "71335-1468-3", "marketing_start_date": "20220512"}, {"sample": false, "description": "8 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-4)", "package_ndc": "71335-1468-4", "marketing_start_date": "20220512"}, {"sample": false, "description": "18 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-5)", "package_ndc": "71335-1468-5", "marketing_start_date": "20220512"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1468-6)", "package_ndc": "71335-1468-6", "marketing_start_date": "20201012"}], "brand_name": "Zolpidem Tartrate", "product_id": "71335-1468_8fc3132f-7766-4459-8ad9-bfc7e998f9bd", "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": "71335-1468", "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": "ANDA204170", "marketing_category": "ANDA", "marketing_start_date": "20170515", "listing_expiration_date": "20261231"}