zolpidem tartrate

Generic: zolpidem tartrate

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

zolpidem tartrate 12.5 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8376
Product ID 68788-8376_fa1a688d-f773-4772-bf54-c1aed9ed8db1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204170
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-03-01

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 687888376
Hyphenated Format 68788-8376

Supplemental Identifiers

RxCUI
854880
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
  • 12.5 mg/1
source: ndc
Packaging
  • 28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-2)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-3)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-6)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-9)
source: ndc

Packages (4)

68788-8376-2 28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-2) 68788-8376-3 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-3) 68788-8376-6 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-6) 68788-8376-9 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-9)

Ingredients (1)

zolpidem tartrate (12.5 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": "fa1a688d-f773-4772-bf54-c1aed9ed8db1", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854880"], "spl_set_id": ["625fad5b-8817-4773-a2fc-20b662140e6e"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-2)", "package_ndc": "68788-8376-2", "marketing_start_date": "20230301"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-3)", "package_ndc": "68788-8376-3", "marketing_start_date": "20230301"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-6)", "package_ndc": "68788-8376-6", "marketing_start_date": "20230301"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8376-9)", "package_ndc": "68788-8376-9", "marketing_start_date": "20230301"}], "brand_name": "Zolpidem Tartrate", "product_id": "68788-8376_fa1a688d-f773-4772-bf54-c1aed9ed8db1", "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": "68788-8376", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zolpidem Tartrate", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "12.5 mg/1"}], "application_number": "ANDA204170", "marketing_category": "ANDA", "marketing_start_date": "20230301", "listing_expiration_date": "20261231"}