zolpidem tartrate (0781-5318)

Drug Facts

Product Profile

Brand Name zolpidem tartrate

Generic Name zolpidem tartrate

Labeler sandoz inc

Dosage Form TABLET, COATED

Routes

ORAL

Active Ingredients

zolpidem tartrate 10 mg/1

Manufacturer

Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-5318

Product ID 0781-5318_d01ebe6c-e538-4039-8af6-cadae62f6989

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA077322

DEA Schedule civ

Listing Expiration 2026-12-31

Marketing Start 2007-04-23

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 07815318

Hyphenated Format 0781-5318

Supplemental Identifiers

RxCUI

854873 854876

UPC

0307815318017 0307815318109 0307815317010 0307815317102

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 ANDA077322 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1

source: ndc

Packaging

100 TABLET, COATED in 1 BOTTLE (0781-5318-01)
500 TABLET, COATED in 1 BOTTLE (0781-5318-05)
1000 TABLET, COATED in 1 BOTTLE (0781-5318-10)
30 TABLET, COATED in 1 BOTTLE (0781-5318-31)

source: ndc

Packages (4)

0781-5318-01 100 TABLET, COATED in 1 BOTTLE (0781-5318-01) 0781-5318-05 500 TABLET, COATED in 1 BOTTLE (0781-5318-05) 0781-5318-10 1000 TABLET, COATED in 1 BOTTLE (0781-5318-10) 0781-5318-31 30 TABLET, COATED in 1 BOTTLE (0781-5318-31)

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": "d01ebe6c-e538-4039-8af6-cadae62f6989", "openfda": {"upc": ["0307815318017", "0307815318109", "0307815317010", "0307815317102"], "unii": ["WY6W63843K"], "rxcui": ["854873", "854876"], "spl_set_id": ["0553e26c-f2aa-43aa-adf9-6eb951a501d3"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (0781-5318-01)", "package_ndc": "0781-5318-01", "marketing_start_date": "20070423"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (0781-5318-05)", "package_ndc": "0781-5318-05", "marketing_start_date": "20070423"}, {"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (0781-5318-10)", "package_ndc": "0781-5318-10", "marketing_start_date": "20070423"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (0781-5318-31)", "package_ndc": "0781-5318-31", "marketing_start_date": "20070423"}], "brand_name": "Zolpidem Tartrate", "product_id": "0781-5318_d01ebe6c-e538-4039-8af6-cadae62f6989", "dosage_form": "TABLET, COATED", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Receptor Positive Modulators [MoA]", "gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]"], "product_ndc": "0781-5318", "dea_schedule": "CIV", "generic_name": "Zolpidem Tartrate", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zolpidem Tartrate", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "10 mg/1"}], "application_number": "ANDA077322", "marketing_category": "ANDA", "marketing_start_date": "20070423", "listing_expiration_date": "20261231"}