zolpidem tartrate

Generic: zolpidem tartrate

Labeler: sanofi-aventis u.s. llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler sanofi-aventis u.s. llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

zolpidem tartrate 12.5 mg/1

Manufacturer
Sanofi-Aventis U.S. LLC

Identifiers & Regulatory

Product NDC 0955-1703
Product ID 0955-1703_0e50b7b1-a680-4009-a8d5-d132b5071499
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021774
DEA Schedule civ
Marketing Start 2010-12-06
Marketing End 2026-05-31

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 09551703
Hyphenated Format 0955-1703

Supplemental Identifiers

RxCUI
854880 854894
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 NDA021774 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0955-1703-10)
source: ndc

Packages (1)

0955-1703-10 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0955-1703-10)

Ingredients (1)

zolpidem tartrate (12.5 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": "0e50b7b1-a680-4009-a8d5-d132b5071499", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854880", "854894"], "spl_set_id": ["68d4314d-1973-481e-806a-da9f5b4baeb0"], "manufacturer_name": ["Sanofi-Aventis U.S. LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0955-1703-10)", "package_ndc": "0955-1703-10", "marketing_end_date": "20260531", "marketing_start_date": "20101206"}], "brand_name": "Zolpidem Tartrate", "product_id": "0955-1703_0e50b7b1-a680-4009-a8d5-d132b5071499", "dosage_form": "TABLET, FILM COATED, 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": "0955-1703", "dea_schedule": "CIV", "generic_name": "zolpidem tartrate", "labeler_name": "Sanofi-Aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zolpidem Tartrate", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "12.5 mg/1"}], "application_number": "NDA021774", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_end_date": "20260531", "marketing_start_date": "20101206"}