zolpidem tartrate

Generic: zolpidem tartrate

Labeler: st. mary's medical park pharmacy
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler st. mary's medical park pharmacy
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

zolpidem tartrate 12.5 mg/1

Manufacturer
ST. MARY'S MEDICAL PARK PHARMACY

Identifiers & Regulatory

Product NDC 60760-819
Product ID 60760-819_21769110-885f-a30e-e063-6394a90a207c
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 60760819
Hyphenated Format 60760-819

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 ANDA078970 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-819-30)
source: ndc

Packages (1)

60760-819-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-819-30)

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": "21769110-885f-a30e-e063-6394a90a207c", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854880"], "spl_set_id": ["21767f56-ce92-2b8c-e063-6394a90a8b76"], "manufacturer_name": ["ST. MARY'S MEDICAL PARK PHARMACY"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-819-30)", "package_ndc": "60760-819-30", "marketing_start_date": "20240828"}], "brand_name": "ZOLPIDEM TARTRATE", "product_id": "60760-819_21769110-885f-a30e-e063-6394a90a207c", "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": "60760-819", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "ST. MARY'S MEDICAL PARK PHARMACY", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZOLPIDEM TARTRATE", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "12.5 mg/1"}], "application_number": "ANDA078970", "marketing_category": "ANDA", "marketing_start_date": "20140411", "listing_expiration_date": "20261231"}