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, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

zolpidem tartrate 6.25 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8654
Product ID 68788-8654_542b2687-71b1-4b46-bf3c-c3f28bfaa724
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078970
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2024-05-09

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 687888654
Hyphenated Format 68788-8654

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 (68788-8654-3)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8654-6)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8654-9)
source: ndc

Packages (3)

68788-8654-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8654-3) 68788-8654-6 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8654-6) 68788-8654-9 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8654-9)

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": "542b2687-71b1-4b46-bf3c-c3f28bfaa724", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854894"], "spl_set_id": ["76ff87e4-3aa2-439d-8436-d9e6affb33c8"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8654-3)", "package_ndc": "68788-8654-3", "marketing_start_date": "20240509"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8654-6)", "package_ndc": "68788-8654-6", "marketing_start_date": "20240509"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8654-9)", "package_ndc": "68788-8654-9", "marketing_start_date": "20240509"}], "brand_name": "ZOLPIDEM TARTRATE", "product_id": "68788-8654_542b2687-71b1-4b46-bf3c-c3f28bfaa724", "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": "68788-8654", "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": "6.25 mg/1"}], "application_number": "ANDA078970", "marketing_category": "ANDA", "marketing_start_date": "20240509", "listing_expiration_date": "20261231"}