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, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

zolpidem tartrate 6.25 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-839
Product ID 71610-839_1a8a808c-982f-49a8-e063-6294a90aa348
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078970
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2014-04-11

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 71610839
Hyphenated Format 71610-839

Supplemental Identifiers

RxCUI
854894
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 ANDA078970 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-839-30)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-839-53)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-839-60)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-839-80)
source: ndc

Packages (4)

71610-839-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-839-30) 71610-839-53 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-839-53) 71610-839-60 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-839-60) 71610-839-80 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-839-80)

Ingredients (1)

zolpidem tartrate (6.25 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": "1a8a808c-982f-49a8-e063-6294a90aa348", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854894"], "spl_set_id": ["1a8a8072-39bf-44c5-e063-6294a90a77c3"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-839-30)", "package_ndc": "71610-839-30", "marketing_start_date": "20240604"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-839-53)", "package_ndc": "71610-839-53", "marketing_start_date": "20240604"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-839-60)", "package_ndc": "71610-839-60", "marketing_start_date": "20240604"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-839-80)", "package_ndc": "71610-839-80", "marketing_start_date": "20240604"}], "brand_name": "ZOLPIDEM TARTRATE", "product_id": "71610-839_1a8a808c-982f-49a8-e063-6294a90aa348", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Receptor Positive Modulators [MoA]", "gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]"], "product_ndc": "71610-839", "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": "6.25 mg/1"}], "application_number": "ANDA078970", "marketing_category": "ANDA", "marketing_start_date": "20140411", "listing_expiration_date": "20261231"}