zolpidem

Generic: zolpidem tartrate

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem
Generic Name zolpidem tartrate
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

zolpidem tartrate 5 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-670
Product ID 71610-670_3613ad67-3a05-4718-8c94-ef4c72a58f12
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077214
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2020-09-24

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 71610670
Hyphenated Format 71610-670

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 (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
  • 30 TABLET in 1 BOTTLE (71610-670-30)
  • 60 TABLET in 1 BOTTLE (71610-670-53)
  • 90 TABLET in 1 BOTTLE (71610-670-60)
  • 120 TABLET in 1 BOTTLE (71610-670-70)
source: ndc

Packages (4)

71610-670-30 30 TABLET in 1 BOTTLE (71610-670-30) 71610-670-53 60 TABLET in 1 BOTTLE (71610-670-53) 71610-670-60 90 TABLET in 1 BOTTLE (71610-670-60) 71610-670-70 120 TABLET in 1 BOTTLE (71610-670-70)

Ingredients (1)

zolpidem tartrate (5 mg/1)

Linked Drug Pages (1)

Zolpidem ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3613ad67-3a05-4718-8c94-ef4c72a58f12", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854876"], "spl_set_id": ["8581cfad-525b-4b16-b116-a5138d9fda52"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-670-30)", "package_ndc": "71610-670-30", "marketing_start_date": "20221018"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-670-53)", "package_ndc": "71610-670-53", "marketing_start_date": "20221018"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-670-60)", "package_ndc": "71610-670-60", "marketing_start_date": "20221018"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71610-670-70)", "package_ndc": "71610-670-70", "marketing_start_date": "20221018"}], "brand_name": "Zolpidem", "product_id": "71610-670_3613ad67-3a05-4718-8c94-ef4c72a58f12", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Agonists [MoA]", "Pyridines [CS]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "71610-670", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zolpidem", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "5 mg/1"}], "application_number": "ANDA077214", "marketing_category": "ANDA", "marketing_start_date": "20200924", "listing_expiration_date": "20261231"}