zolpidem tartrate

Generic: zolpidem tartrate

Labeler: the acme laboratories ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler the acme laboratories ltd.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

zolpidem tartrate 5 mg/1

Manufacturer
The ACME Laboratories Ltd.

Identifiers & Regulatory

Product NDC 72722-103
Product ID 72722-103_e49e41d7-0f51-464f-8e31-2fb446e5f1e8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077214
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2020-09-24

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 72722103
Hyphenated Format 72722-103

Supplemental Identifiers

RxCUI
854873 854876
UPC
0372722103070 0372722104077
UNII
WY6W63843K

Packaging Origin

Original Packager
true

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 ANDA077214 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72722-103-01)
  • 100 TABLET, FILM COATED in 1 BOTTLE (72722-103-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (72722-103-07)
source: ndc

Packages (3)

72722-103-01 30 TABLET, FILM COATED in 1 BOTTLE (72722-103-01) 72722-103-05 100 TABLET, FILM COATED in 1 BOTTLE (72722-103-05) 72722-103-07 1000 TABLET, FILM COATED in 1 BOTTLE (72722-103-07)

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": "e49e41d7-0f51-464f-8e31-2fb446e5f1e8", "openfda": {"upc": ["0372722103070", "0372722104077"], "unii": ["WY6W63843K"], "rxcui": ["854873", "854876"], "spl_set_id": ["5679ed64-8424-4e63-a3c9-91d80fff2ca6"], "manufacturer_name": ["The ACME Laboratories Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72722-103-01)", "package_ndc": "72722-103-01", "marketing_start_date": "20241130"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (72722-103-05)", "package_ndc": "72722-103-05", "marketing_start_date": "20241130"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (72722-103-07)", "package_ndc": "72722-103-07", "marketing_start_date": "20241130"}], "brand_name": "ZOLPIDEM TARTRATE", "product_id": "72722-103_e49e41d7-0f51-464f-8e31-2fb446e5f1e8", "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": "72722-103", "dea_schedule": "CIV", "generic_name": "zolpidem tartrate", "labeler_name": "The ACME Laboratories Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZOLPIDEM TARTRATE", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "5 mg/1"}], "application_number": "ANDA077214", "marketing_category": "ANDA", "marketing_start_date": "20200924", "listing_expiration_date": "20261231"}