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 10 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-848
Product ID 71610-848_35bc5d7a-4115-4fd4-e063-6394a90a4f20
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 71610848
Hyphenated Format 71610-848

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 (source: ndc)
Generic Name zolpidem tartrate (source: ndc)
Application Number ANDA077214 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE (71610-848-10)
  • 14 TABLET in 1 BOTTLE (71610-848-14)
  • 15 TABLET in 1 BOTTLE (71610-848-15)
  • 20 TABLET in 1 BOTTLE (71610-848-20)
  • 21 TABLET in 1 BOTTLE (71610-848-21)
  • 25 TABLET in 1 BOTTLE (71610-848-25)
  • 28 TABLET in 1 BOTTLE (71610-848-28)
  • 30 TABLET in 1 BOTTLE (71610-848-30)
  • 45 TABLET in 1 BOTTLE (71610-848-45)
  • 60 TABLET in 1 BOTTLE (71610-848-53)
  • 90 TABLET in 1 BOTTLE (71610-848-60)
source: ndc

Packages (11)

71610-848-10 10 TABLET in 1 BOTTLE (71610-848-10) 71610-848-14 14 TABLET in 1 BOTTLE (71610-848-14) 71610-848-15 15 TABLET in 1 BOTTLE (71610-848-15) 71610-848-20 20 TABLET in 1 BOTTLE (71610-848-20) 71610-848-21 21 TABLET in 1 BOTTLE (71610-848-21) 71610-848-25 25 TABLET in 1 BOTTLE (71610-848-25) 71610-848-28 28 TABLET in 1 BOTTLE (71610-848-28) 71610-848-30 30 TABLET in 1 BOTTLE (71610-848-30) 71610-848-45 45 TABLET in 1 BOTTLE (71610-848-45) 71610-848-53 60 TABLET in 1 BOTTLE (71610-848-53) 71610-848-60 90 TABLET in 1 BOTTLE (71610-848-60)

Ingredients (1)

zolpidem tartrate (10 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": "35bc5d7a-4115-4fd4-e063-6394a90a4f20", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854873"], "spl_set_id": ["1e15d6e3-8d06-0936-e063-6394a90ab8db"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (71610-848-10)", "package_ndc": "71610-848-10", "marketing_start_date": "20240729"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE (71610-848-14)", "package_ndc": "71610-848-14", "marketing_start_date": "20250227"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (71610-848-15)", "package_ndc": "71610-848-15", "marketing_start_date": "20240725"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (71610-848-20)", "package_ndc": "71610-848-20", "marketing_start_date": "20240725"}, {"sample": false, "description": "21 TABLET in 1 BOTTLE (71610-848-21)", "package_ndc": "71610-848-21", "marketing_start_date": "20240725"}, {"sample": false, "description": "25 TABLET in 1 BOTTLE (71610-848-25)", "package_ndc": "71610-848-25", "marketing_start_date": "20250520"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE (71610-848-28)", "package_ndc": "71610-848-28", "marketing_start_date": "20240809"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-848-30)", "package_ndc": "71610-848-30", "marketing_start_date": "20240725"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-848-45)", "package_ndc": "71610-848-45", "marketing_start_date": "20240725"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-848-53)", "package_ndc": "71610-848-53", "marketing_start_date": "20240725"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-848-60)", "package_ndc": "71610-848-60", "marketing_start_date": "20240815"}], "brand_name": "Zolpidem", "product_id": "71610-848_35bc5d7a-4115-4fd4-e063-6394a90a4f20", "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": "71610-848", "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": "10 mg/1"}], "application_number": "ANDA077214", "marketing_category": "ANDA", "marketing_start_date": "20070423", "listing_expiration_date": "20261231"}