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 71610-847
Product ID 71610-847_23437493-e8b9-2892-e063-6394a90af267
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 71610847
Hyphenated Format 71610-847

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
  • 10 TABLET in 1 BOTTLE (71610-847-10)
  • 14 TABLET in 1 BOTTLE (71610-847-14)
  • 15 TABLET in 1 BOTTLE (71610-847-15)
  • 20 TABLET in 1 BOTTLE (71610-847-20)
  • 21 TABLET in 1 BOTTLE (71610-847-21)
  • 28 TABLET in 1 BOTTLE (71610-847-28)
  • 30 TABLET in 1 BOTTLE (71610-847-30)
  • 45 TABLET in 1 BOTTLE (71610-847-45)
  • 60 TABLET in 1 BOTTLE (71610-847-53)
  • 90 TABLET in 1 BOTTLE (71610-847-60)
source: ndc

Packages (10)

71610-847-10 10 TABLET in 1 BOTTLE (71610-847-10) 71610-847-14 14 TABLET in 1 BOTTLE (71610-847-14) 71610-847-15 15 TABLET in 1 BOTTLE (71610-847-15) 71610-847-20 20 TABLET in 1 BOTTLE (71610-847-20) 71610-847-21 21 TABLET in 1 BOTTLE (71610-847-21) 71610-847-28 28 TABLET in 1 BOTTLE (71610-847-28) 71610-847-30 30 TABLET in 1 BOTTLE (71610-847-30) 71610-847-45 45 TABLET in 1 BOTTLE (71610-847-45) 71610-847-53 60 TABLET in 1 BOTTLE (71610-847-53) 71610-847-60 90 TABLET in 1 BOTTLE (71610-847-60)

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": "23437493-e8b9-2892-e063-6394a90af267", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854876"], "spl_set_id": ["1e13ad50-f846-813a-e063-6294a90a5878"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (71610-847-10)", "package_ndc": "71610-847-10", "marketing_start_date": "20240821"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE (71610-847-14)", "package_ndc": "71610-847-14", "marketing_start_date": "20240927"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (71610-847-15)", "package_ndc": "71610-847-15", "marketing_start_date": "20240724"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (71610-847-20)", "package_ndc": "71610-847-20", "marketing_start_date": "20240724"}, {"sample": false, "description": "21 TABLET in 1 BOTTLE (71610-847-21)", "package_ndc": "71610-847-21", "marketing_start_date": "20240724"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE (71610-847-28)", "package_ndc": "71610-847-28", "marketing_start_date": "20240724"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-847-30)", "package_ndc": "71610-847-30", "marketing_start_date": "20240724"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-847-45)", "package_ndc": "71610-847-45", "marketing_start_date": "20240724"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-847-53)", "package_ndc": "71610-847-53", "marketing_start_date": "20240724"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-847-60)", "package_ndc": "71610-847-60", "marketing_start_date": "20240724"}], "brand_name": "Zolpidem", "product_id": "71610-847_23437493-e8b9-2892-e063-6394a90af267", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Receptor Positive Modulators [MoA]", "gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]"], "product_ndc": "71610-847", "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": "20070423", "listing_expiration_date": "20261231"}