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, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

zolpidem tartrate 6.25 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-913
Product ID 71610-913_8a13a4cc-3230-4119-9b8c-02fde0298d45
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204170
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2017-05-15

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 71610913
Hyphenated Format 71610-913

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 ANDA204170 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-913-30)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-913-53)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-913-60)
source: ndc

Packages (3)

71610-913-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-913-30) 71610-913-53 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-913-53) 71610-913-60 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-913-60)

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": "8a13a4cc-3230-4119-9b8c-02fde0298d45", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854894"], "spl_set_id": ["a1faca42-6e46-4586-97ac-050b724e7d2a"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-913-30)", "package_ndc": "71610-913-30", "marketing_start_date": "20250605"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-913-53)", "package_ndc": "71610-913-53", "marketing_start_date": "20250605"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-913-60)", "package_ndc": "71610-913-60", "marketing_start_date": "20250605"}], "brand_name": "Zolpidem Tartrate", "product_id": "71610-913_8a13a4cc-3230-4119-9b8c-02fde0298d45", "dosage_form": "TABLET, FILM COATED, 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": "71610-913", "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": "ANDA204170", "marketing_category": "ANDA", "marketing_start_date": "20170515", "listing_expiration_date": "20261231"}