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 10 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-323
Product ID 72789-323_2c50fde4-3d33-4137-e063-6394a90a73d6
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 72789323
Hyphenated Format 72789-323

Supplemental Identifiers

RxCUI
854873
UPC
0372789323305
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
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-01)
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-10)
  • 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-14)
  • 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-15)
  • 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-21)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-60)
source: ndc

Packages (7)

72789-323-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-01) 72789-323-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-10) 72789-323-14 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-14) 72789-323-15 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-15) 72789-323-21 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-21) 72789-323-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-30) 72789-323-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-60)

Ingredients (1)

zolpidem tartrate (10 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": "2c50fde4-3d33-4137-e063-6394a90a73d6", "openfda": {"upc": ["0372789323305"], "unii": ["WY6W63843K"], "rxcui": ["854873"], "spl_set_id": ["fda413e7-b1ae-312a-e053-6394a90ab2c6"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-01)", "package_ndc": "72789-323-01", "marketing_start_date": "20070504"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-10)", "package_ndc": "72789-323-10", "marketing_start_date": "20231030"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-14)", "package_ndc": "72789-323-14", "marketing_start_date": "20240110"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-15)", "package_ndc": "72789-323-15", "marketing_start_date": "20230925"}, {"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-21)", "package_ndc": "72789-323-21", "marketing_start_date": "20231109"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-30)", "package_ndc": "72789-323-30", "marketing_start_date": "20070504"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-60)", "package_ndc": "72789-323-60", "marketing_start_date": "20070504"}], "brand_name": "Zolpidem Tartrate", "product_id": "72789-323_2c50fde4-3d33-4137-e063-6394a90a73d6", "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": "72789-323", "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": "10 mg/1"}], "application_number": "ANDA078413", "marketing_category": "ANDA", "marketing_start_date": "20070504", "listing_expiration_date": "20261231"}