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 71610-192
Product ID 71610-192_b721f5f7-f18b-4d24-a12d-afaf21d21ea3
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 71610192
Hyphenated Format 71610-192

Supplemental Identifiers

RxCUI
854873
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
  • 10 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (71610-192-15)
  • 20 TABLET, FILM COATED in 1 BOTTLE (71610-192-20)
  • 25 TABLET, FILM COATED in 1 BOTTLE (71610-192-25)
  • 28 TABLET, FILM COATED in 1 BOTTLE (71610-192-28)
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-192-30)
  • 22 TABLET, FILM COATED in 1 BOTTLE (71610-192-59)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-192-60)
source: ndc

Packages (7)

71610-192-15 15 TABLET, FILM COATED in 1 BOTTLE (71610-192-15) 71610-192-20 20 TABLET, FILM COATED in 1 BOTTLE (71610-192-20) 71610-192-25 25 TABLET, FILM COATED in 1 BOTTLE (71610-192-25) 71610-192-28 28 TABLET, FILM COATED in 1 BOTTLE (71610-192-28) 71610-192-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-192-30) 71610-192-59 22 TABLET, FILM COATED in 1 BOTTLE (71610-192-59) 71610-192-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-192-60)

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": "b721f5f7-f18b-4d24-a12d-afaf21d21ea3", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854873"], "spl_set_id": ["acfcfe91-83a0-44ab-95c0-dd98b73ac69a"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71610-192-15)", "package_ndc": "71610-192-15", "marketing_start_date": "20181108"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (71610-192-20)", "package_ndc": "71610-192-20", "marketing_start_date": "20181108"}, {"sample": false, "description": "25 TABLET, FILM COATED in 1 BOTTLE (71610-192-25)", "package_ndc": "71610-192-25", "marketing_start_date": "20181108"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE (71610-192-28)", "package_ndc": "71610-192-28", "marketing_start_date": "20181108"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-192-30)", "package_ndc": "71610-192-30", "marketing_start_date": "20181108"}, {"sample": false, "description": "22 TABLET, FILM COATED in 1 BOTTLE (71610-192-59)", "package_ndc": "71610-192-59", "marketing_start_date": "20181108"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-192-60)", "package_ndc": "71610-192-60", "marketing_start_date": "20181108"}], "brand_name": "Zolpidem Tartrate", "product_id": "71610-192_b721f5f7-f18b-4d24-a12d-afaf21d21ea3", "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": "71610-192", "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": "ANDA078413", "marketing_category": "ANDA", "marketing_start_date": "20070504", "listing_expiration_date": "20261231"}