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 71610-156
Product ID 71610-156_054ab49e-270f-497f-a5ed-a46264e5e282
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 71610156
Hyphenated Format 71610-156

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 ANDA078413 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-156-30)
source: ndc

Packages (1)

71610-156-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-156-30)

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": "054ab49e-270f-497f-a5ed-a46264e5e282", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854876"], "spl_set_id": ["7be7f243-e6f8-406f-aed7-be7cedd5630a"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-156-30)", "package_ndc": "71610-156-30", "marketing_start_date": "20180920"}], "brand_name": "Zolpidem Tartrate", "product_id": "71610-156_054ab49e-270f-497f-a5ed-a46264e5e282", "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": "71610-156", "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"}