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 10 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-273
Product ID 71610-273_07f9f5a9-e902-40f5-96c9-f7a232037a4c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076410
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2019-02-21

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 71610273
Hyphenated Format 71610-273

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 ANDA076410 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE (71610-273-10)
  • 14 TABLET, FILM COATED in 1 BOTTLE (71610-273-14)
  • 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-273-15)
  • 20 TABLET, FILM COATED in 1 BOTTLE (71610-273-20)
  • 21 TABLET, FILM COATED in 1 BOTTLE (71610-273-21)
  • 25 TABLET, FILM COATED in 1 BOTTLE (71610-273-25)
  • 28 TABLET, FILM COATED in 1 BOTTLE (71610-273-28)
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-273-30)
  • 45 TABLET, FILM COATED in 1 BOTTLE (71610-273-45)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71610-273-53)
  • 22 TABLET, FILM COATED in 1 BOTTLE (71610-273-59)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-273-60)
  • 11 TABLET, FILM COATED in 1 BOTTLE (71610-273-62)
source: ndc

Packages (13)

71610-273-10 10 TABLET, FILM COATED in 1 BOTTLE (71610-273-10) 71610-273-14 14 TABLET, FILM COATED in 1 BOTTLE (71610-273-14) 71610-273-15 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-273-15) 71610-273-20 20 TABLET, FILM COATED in 1 BOTTLE (71610-273-20) 71610-273-21 21 TABLET, FILM COATED in 1 BOTTLE (71610-273-21) 71610-273-25 25 TABLET, FILM COATED in 1 BOTTLE (71610-273-25) 71610-273-28 28 TABLET, FILM COATED in 1 BOTTLE (71610-273-28) 71610-273-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-273-30) 71610-273-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-273-45) 71610-273-53 60 TABLET, FILM COATED in 1 BOTTLE (71610-273-53) 71610-273-59 22 TABLET, FILM COATED in 1 BOTTLE (71610-273-59) 71610-273-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-273-60) 71610-273-62 11 TABLET, FILM COATED in 1 BOTTLE (71610-273-62)

Ingredients (1)

zolpidem tartrate (10 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": "07f9f5a9-e902-40f5-96c9-f7a232037a4c", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854873", "854876"], "spl_set_id": ["980d5942-9cc9-483b-98da-2369699060a5"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (71610-273-10)", "package_ndc": "71610-273-10", "marketing_start_date": "20190506"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (71610-273-14)", "package_ndc": "71610-273-14", "marketing_start_date": "20190506"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-273-15)", "package_ndc": "71610-273-15", "marketing_start_date": "20190506"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (71610-273-20)", "package_ndc": "71610-273-20", "marketing_start_date": "20190506"}, {"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE (71610-273-21)", "package_ndc": "71610-273-21", "marketing_start_date": "20190506"}, {"sample": false, "description": "25 TABLET, FILM COATED in 1 BOTTLE (71610-273-25)", "package_ndc": "71610-273-25", "marketing_start_date": "20190506"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE (71610-273-28)", "package_ndc": "71610-273-28", "marketing_start_date": "20190506"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-273-30)", "package_ndc": "71610-273-30", "marketing_start_date": "20190506"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71610-273-45)", "package_ndc": "71610-273-45", "marketing_start_date": "20190506"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71610-273-53)", "package_ndc": "71610-273-53", "marketing_start_date": "20190506"}, {"sample": false, "description": "22 TABLET, FILM COATED in 1 BOTTLE (71610-273-59)", "package_ndc": "71610-273-59", "marketing_start_date": "20190506"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-273-60)", "package_ndc": "71610-273-60", "marketing_start_date": "20190506"}, {"sample": false, "description": "11 TABLET, FILM COATED in 1 BOTTLE (71610-273-62)", "package_ndc": "71610-273-62", "marketing_start_date": "20190506"}], "brand_name": "Zolpidem Tartrate", "product_id": "71610-273_07f9f5a9-e902-40f5-96c9-f7a232037a4c", "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": "71610-273", "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": "10 mg/1"}], "application_number": "ANDA076410", "marketing_category": "ANDA", "marketing_start_date": "20190221", "listing_expiration_date": "20261231"}