eszopiclone

Generic: eszopiclone

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eszopiclone
Generic Name eszopiclone
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

eszopiclone 3 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-409
Product ID 71610-409_fa699b0f-cb02-4a27-b97a-80221ebeabed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091169
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2014-04-14

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610409
Hyphenated Format 71610-409

Supplemental Identifiers

RxCUI
485465
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 ANDA091169 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-409-30)
source: ndc

Packages (1)

71610-409-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-409-30)

Ingredients (1)

eszopiclone (3 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": "fa699b0f-cb02-4a27-b97a-80221ebeabed", "openfda": {"unii": ["UZX80K71OE"], "rxcui": ["485465"], "spl_set_id": ["9bbf260f-3090-46b5-b3ef-81174697f166"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-409-30)", "package_ndc": "71610-409-30", "marketing_start_date": "20200326"}], "brand_name": "Eszopiclone", "product_id": "71610-409_fa699b0f-cb02-4a27-b97a-80221ebeabed", "dosage_form": "TABLET, FILM COATED", "product_ndc": "71610-409", "dea_schedule": "CIV", "generic_name": "Eszopiclone", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eszopiclone", "active_ingredients": [{"name": "ESZOPICLONE", "strength": "3 mg/1"}], "application_number": "ANDA091169", "marketing_category": "ANDA", "marketing_start_date": "20140414", "listing_expiration_date": "20261231"}