eszopiclone

Generic: eszopiclone

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eszopiclone
Generic Name eszopiclone
Labeler advanced rx of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

eszopiclone 1 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0407
Product ID 80425-0407_1baa56ec-7eaf-dda0-e063-6394a90af453
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091166
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2024-06-24

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250407
Hyphenated Format 80425-0407

Supplemental Identifiers

RxCUI
485440
UNII
UZX80K71OE

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 eszopiclone (source: ndc)
Generic Name eszopiclone (source: ndc)
Application Number ANDA091166 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (80425-0407-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (80425-0407-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (80425-0407-3)
source: ndc

Packages (3)

80425-0407-1 30 TABLET, FILM COATED in 1 BOTTLE (80425-0407-1) 80425-0407-2 60 TABLET, FILM COATED in 1 BOTTLE (80425-0407-2) 80425-0407-3 90 TABLET, FILM COATED in 1 BOTTLE (80425-0407-3)

Ingredients (1)

eszopiclone (1 mg/1)

Linked Drug Pages (1)

Eszopiclone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1baa56ec-7eaf-dda0-e063-6394a90af453", "openfda": {"unii": ["UZX80K71OE"], "rxcui": ["485440"], "spl_set_id": ["1baa56e5-34d5-c8a1-e063-6394a90ae6c7"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0407-1)", "package_ndc": "80425-0407-1", "marketing_start_date": "20240624"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0407-2)", "package_ndc": "80425-0407-2", "marketing_start_date": "20240624"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (80425-0407-3)", "package_ndc": "80425-0407-3", "marketing_start_date": "20240624"}], "brand_name": "Eszopiclone", "product_id": "80425-0407_1baa56ec-7eaf-dda0-e063-6394a90af453", "dosage_form": "TABLET, FILM COATED", "product_ndc": "80425-0407", "dea_schedule": "CIV", "generic_name": "Eszopiclone", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eszopiclone", "active_ingredients": [{"name": "ESZOPICLONE", "strength": "1 mg/1"}], "application_number": "ANDA091166", "marketing_category": "ANDA", "marketing_start_date": "20240624", "listing_expiration_date": "20261231"}