zolpidem tartrate

Generic: zolpidem tartrate

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC 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 71610-770
Product ID 71610-770_4602534f-29d4-4797-95d1-479735045513
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021774
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2010-10-14

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 71610770
Hyphenated Format 71610-770

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 NDA021774 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-770-15)
  • 28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-770-28)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-770-30)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-770-53)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-770-60)
source: ndc

Packages (5)

71610-770-15 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-770-15) 71610-770-28 28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-770-28) 71610-770-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-770-30) 71610-770-53 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-770-53) 71610-770-60 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-770-60)

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": "4602534f-29d4-4797-95d1-479735045513", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854894"], "spl_set_id": ["39d91478-ea0e-407e-b5cb-0eeb592e0aa4"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-770-15)", "package_ndc": "71610-770-15", "marketing_start_date": "20240119"}, {"sample": false, "description": "28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-770-28)", "package_ndc": "71610-770-28", "marketing_start_date": "20240119"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-770-30)", "package_ndc": "71610-770-30", "marketing_start_date": "20240119"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-770-53)", "package_ndc": "71610-770-53", "marketing_start_date": "20240119"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-770-60)", "package_ndc": "71610-770-60", "marketing_start_date": "20240119"}], "brand_name": "Zolpidem Tartrate", "product_id": "71610-770_4602534f-29d4-4797-95d1-479735045513", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Agonists [MoA]", "Pyridines [CS]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "71610-770", "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": "NDA021774", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20101014", "listing_expiration_date": "20261231"}