zolpidem tartrate

Generic: zolpidem tartrate

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler sandoz inc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

zolpidem tartrate 6.25 mg/1

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-5315
Product ID 0781-5315_0751e4b8-384e-4336-9e51-02d6b07a7777
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090107
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2011-10-31

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 07815315
Hyphenated Format 0781-5315

Supplemental Identifiers

RxCUI
854880 854894
UPC
0307815315016 0307815316013
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 ANDA090107 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5315-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5315-05)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5315-31)
source: ndc

Packages (3)

0781-5315-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5315-01) 0781-5315-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5315-05) 0781-5315-31 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5315-31)

Ingredients (1)

zolpidem tartrate (6.25 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": "0751e4b8-384e-4336-9e51-02d6b07a7777", "openfda": {"upc": ["0307815315016", "0307815316013"], "unii": ["WY6W63843K"], "rxcui": ["854880", "854894"], "spl_set_id": ["b1b0085f-d9fe-430a-9bd5-607f607bf7e1"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5315-01)", "package_ndc": "0781-5315-01", "marketing_start_date": "20111031"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5315-05)", "package_ndc": "0781-5315-05", "marketing_start_date": "20111031"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5315-31)", "package_ndc": "0781-5315-31", "marketing_start_date": "20111031"}], "brand_name": "Zolpidem tartrate", "product_id": "0781-5315_0751e4b8-384e-4336-9e51-02d6b07a7777", "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": "0781-5315", "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": "6.25 mg/1"}], "application_number": "ANDA090107", "marketing_category": "ANDA", "marketing_start_date": "20111031", "listing_expiration_date": "20261231"}