zolpidem tartrate

Generic: zolpidem tartrate

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

zolpidem tartrate 5 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-151
Product ID 71610-151_4226ed40-0715-4369-87ae-4c2c190fff49
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078413
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2007-05-04

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 71610151
Hyphenated Format 71610-151

Supplemental Identifiers

RxCUI
854873 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 tartrate (source: ndc)
Generic Name zolpidem tartrate (source: ndc)
Application Number ANDA078413 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (71610-151-15)
  • 20 TABLET, FILM COATED in 1 BOTTLE (71610-151-20)
  • 28 TABLET, FILM COATED in 1 BOTTLE (71610-151-28)
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-151-30)
  • 45 TABLET, FILM COATED in 1 BOTTLE (71610-151-45)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71610-151-53)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-151-60)
source: ndc

Packages (7)

71610-151-15 15 TABLET, FILM COATED in 1 BOTTLE (71610-151-15) 71610-151-20 20 TABLET, FILM COATED in 1 BOTTLE (71610-151-20) 71610-151-28 28 TABLET, FILM COATED in 1 BOTTLE (71610-151-28) 71610-151-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-151-30) 71610-151-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-151-45) 71610-151-53 60 TABLET, FILM COATED in 1 BOTTLE (71610-151-53) 71610-151-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-151-60)

Ingredients (1)

zolpidem tartrate (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": "4226ed40-0715-4369-87ae-4c2c190fff49", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854873", "854876"], "spl_set_id": ["7abb6898-223c-487b-856c-068ac04f7a5c"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71610-151-15)", "package_ndc": "71610-151-15", "marketing_start_date": "20180918"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (71610-151-20)", "package_ndc": "71610-151-20", "marketing_start_date": "20180918"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE (71610-151-28)", "package_ndc": "71610-151-28", "marketing_start_date": "20180918"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-151-30)", "package_ndc": "71610-151-30", "marketing_start_date": "20180918"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71610-151-45)", "package_ndc": "71610-151-45", "marketing_start_date": "20180918"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71610-151-53)", "package_ndc": "71610-151-53", "marketing_start_date": "20180918"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-151-60)", "package_ndc": "71610-151-60", "marketing_start_date": "20180918"}], "brand_name": "Zolpidem Tartrate", "product_id": "71610-151_4226ed40-0715-4369-87ae-4c2c190fff49", "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": "71610-151", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zolpidem Tartrate", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "5 mg/1"}], "application_number": "ANDA078413", "marketing_category": "ANDA", "marketing_start_date": "20070504", "listing_expiration_date": "20261231"}