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 71610-272
Product ID 71610-272_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 71610272
Hyphenated Format 71610-272

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
  • 5 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE (71610-272-10)
  • 14 TABLET, FILM COATED in 1 BOTTLE (71610-272-14)
  • 15 TABLET, FILM COATED in 1 BOTTLE (71610-272-15)
  • 20 TABLET, FILM COATED in 1 BOTTLE (71610-272-20)
  • 28 TABLET, FILM COATED in 1 BOTTLE (71610-272-28)
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-272-30)
  • 45 TABLET, FILM COATED in 1 BOTTLE (71610-272-45)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71610-272-53)
  • 22 TABLET, FILM COATED in 1 BOTTLE (71610-272-59)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-272-60)
source: ndc

Packages (10)

71610-272-10 10 TABLET, FILM COATED in 1 BOTTLE (71610-272-10) 71610-272-14 14 TABLET, FILM COATED in 1 BOTTLE (71610-272-14) 71610-272-15 15 TABLET, FILM COATED in 1 BOTTLE (71610-272-15) 71610-272-20 20 TABLET, FILM COATED in 1 BOTTLE (71610-272-20) 71610-272-28 28 TABLET, FILM COATED in 1 BOTTLE (71610-272-28) 71610-272-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-272-30) 71610-272-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-272-45) 71610-272-53 60 TABLET, FILM COATED in 1 BOTTLE (71610-272-53) 71610-272-59 22 TABLET, FILM COATED in 1 BOTTLE (71610-272-59) 71610-272-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-272-60)

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": "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 (71610-272-10)", "package_ndc": "71610-272-10", "marketing_start_date": "20190501"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (71610-272-14)", "package_ndc": "71610-272-14", "marketing_start_date": "20190501"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71610-272-15)", "package_ndc": "71610-272-15", "marketing_start_date": "20190501"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (71610-272-20)", "package_ndc": "71610-272-20", "marketing_start_date": "20190501"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE (71610-272-28)", "package_ndc": "71610-272-28", "marketing_start_date": "20190501"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-272-30)", "package_ndc": "71610-272-30", "marketing_start_date": "20190501"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71610-272-45)", "package_ndc": "71610-272-45", "marketing_start_date": "20190501"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71610-272-53)", "package_ndc": "71610-272-53", "marketing_start_date": "20190501"}, {"sample": false, "description": "22 TABLET, FILM COATED in 1 BOTTLE (71610-272-59)", "package_ndc": "71610-272-59", "marketing_start_date": "20190501"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-272-60)", "package_ndc": "71610-272-60", "marketing_start_date": "20190501"}], "brand_name": "Zolpidem Tartrate", "product_id": "71610-272_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": "71610-272", "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": "ANDA076410", "marketing_category": "ANDA", "marketing_start_date": "20190221", "listing_expiration_date": "20261231"}