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 71610-904
Product ID 71610-904_35d0e953-2920-f36b-e063-6294a90a7d52
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077214
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2007-04-23

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 71610904
Hyphenated Format 71610-904

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 tartrate (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
  • 10 TABLET, FILM COATED in 1 BOTTLE (71610-904-10)
  • 14 TABLET, FILM COATED in 1 BOTTLE (71610-904-14)
  • 15 TABLET, FILM COATED in 1 BOTTLE (71610-904-15)
  • 20 TABLET, FILM COATED in 1 BOTTLE (71610-904-20)
  • 28 TABLET, FILM COATED in 1 BOTTLE (71610-904-28)
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-904-30)
  • 45 TABLET, FILM COATED in 1 BOTTLE (71610-904-45)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71610-904-53)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-904-60)
source: ndc

Packages (9)

71610-904-10 10 TABLET, FILM COATED in 1 BOTTLE (71610-904-10) 71610-904-14 14 TABLET, FILM COATED in 1 BOTTLE (71610-904-14) 71610-904-15 15 TABLET, FILM COATED in 1 BOTTLE (71610-904-15) 71610-904-20 20 TABLET, FILM COATED in 1 BOTTLE (71610-904-20) 71610-904-28 28 TABLET, FILM COATED in 1 BOTTLE (71610-904-28) 71610-904-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-904-30) 71610-904-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-904-45) 71610-904-53 60 TABLET, FILM COATED in 1 BOTTLE (71610-904-53) 71610-904-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-904-60)

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": "35d0e953-2920-f36b-e063-6294a90a7d52", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854876"], "spl_set_id": ["349053e4-9885-ec0b-e063-6294a90ad79a"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (71610-904-10)", "package_ndc": "71610-904-10", "marketing_start_date": "20250506"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (71610-904-14)", "package_ndc": "71610-904-14", "marketing_start_date": "20250506"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71610-904-15)", "package_ndc": "71610-904-15", "marketing_start_date": "20250506"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (71610-904-20)", "package_ndc": "71610-904-20", "marketing_start_date": "20250513"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE (71610-904-28)", "package_ndc": "71610-904-28", "marketing_start_date": "20250506"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-904-30)", "package_ndc": "71610-904-30", "marketing_start_date": "20250506"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71610-904-45)", "package_ndc": "71610-904-45", "marketing_start_date": "20250506"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71610-904-53)", "package_ndc": "71610-904-53", "marketing_start_date": "20250506"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-904-60)", "package_ndc": "71610-904-60", "marketing_start_date": "20250506"}], "brand_name": "ZOLPIDEM TARTRATE", "product_id": "71610-904_35d0e953-2920-f36b-e063-6294a90a7d52", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Receptor Positive Modulators [MoA]", "gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]"], "product_ndc": "71610-904", "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": "ANDA077214", "marketing_category": "ANDA", "marketing_start_date": "20070423", "listing_expiration_date": "20261231"}