zolpidem tartrate

Generic: zolpidem tartrate

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

zolpidem tartrate 5 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-390
Product ID 72789-390_2cefff0f-97f2-c4cb-e063-6394a90a0eba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078413
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2007-05-04

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 72789390
Hyphenated Format 72789-390

Supplemental Identifiers

RxCUI
854876
UPC
0372789390307
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 ANDA078413 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-390-21)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-390-30)
source: ndc

Packages (2)

72789-390-21 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-390-21) 72789-390-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-390-30)

Ingredients (1)

zolpidem tartrate (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": "2cefff0f-97f2-c4cb-e063-6394a90a0eba", "openfda": {"upc": ["0372789390307"], "unii": ["WY6W63843K"], "rxcui": ["854876"], "spl_set_id": ["38c838a4-9943-445a-8e80-e823d56eeaa5"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-390-21)", "package_ndc": "72789-390-21", "marketing_start_date": "20240403"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-390-30)", "package_ndc": "72789-390-30", "marketing_start_date": "20240403"}], "brand_name": "Zolpidem Tartrate", "product_id": "72789-390_2cefff0f-97f2-c4cb-e063-6394a90a0eba", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Receptor Positive Modulators [MoA]", "gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]"], "product_ndc": "72789-390", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zolpidem Tartrate", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "5 mg/1"}], "application_number": "ANDA078413", "marketing_category": "ANDA", "marketing_start_date": "20070504", "listing_expiration_date": "20261231"}