zolpidem tartrate

Generic: zolpidem tartrate

Labeler: lake erie medical dba quality care products llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolpidem tartrate
Generic Name zolpidem tartrate
Labeler lake erie medical dba quality care products llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

zolpidem tartrate 10 mg/1

Manufacturer
Lake Erie Medical DBA Quality Care Products LLC

Identifiers & Regulatory

Product NDC 55700-357
Product ID 55700-357_441aafa7-9b54-4c40-8339-afb197dab6e0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077903
DEA Schedule civ
Marketing Start 2007-09-05
Marketing End 2027-10-31

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 55700357
Hyphenated Format 55700-357

Supplemental Identifiers

RxCUI
854873
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 ANDA077903 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (55700-357-30)
source: ndc

Packages (1)

55700-357-30 30 TABLET in 1 BOTTLE (55700-357-30)

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": "441aafa7-9b54-4c40-8339-afb197dab6e0", "openfda": {"unii": ["WY6W63843K"], "rxcui": ["854873"], "spl_set_id": ["db735db9-1c82-4d32-bf91-97b05a75e876"], "manufacturer_name": ["Lake Erie Medical DBA Quality Care Products LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (55700-357-30)", "package_ndc": "55700-357-30", "marketing_end_date": "20271031", "marketing_start_date": "20160113"}], "brand_name": "ZOLPIDEM TARTRATE", "product_id": "55700-357_441aafa7-9b54-4c40-8339-afb197dab6e0", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Depression [PE]", "GABA A Receptor Positive Modulators [MoA]", "gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]"], "product_ndc": "55700-357", "dea_schedule": "CIV", "generic_name": "zolpidem tartrate", "labeler_name": "Lake Erie Medical DBA Quality Care Products LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZOLPIDEM TARTRATE", "active_ingredients": [{"name": "ZOLPIDEM TARTRATE", "strength": "10 mg/1"}], "application_number": "ANDA077903", "marketing_category": "ANDA", "marketing_end_date": "20271031", "marketing_start_date": "20070905"}