eszopiclone

Generic: eszopiclone

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eszopiclone
Generic Name eszopiclone
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

eszopiclone 2 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-968
Product ID 65862-968_a39aa520-c8ad-4f39-ad71-04a839474b5b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208451
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2016-09-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862968
Hyphenated Format 65862-968

Supplemental Identifiers

RxCUI
485440 485442 485465
UNII
UZX80K71OE

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 eszopiclone (source: ndc)
Generic Name eszopiclone (source: ndc)
Application Number ANDA208451 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-968-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-968-30)
source: ndc

Packages (2)

65862-968-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-968-01) 65862-968-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-968-30)

Ingredients (1)

eszopiclone (2 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": "a39aa520-c8ad-4f39-ad71-04a839474b5b", "openfda": {"unii": ["UZX80K71OE"], "rxcui": ["485440", "485442", "485465"], "spl_set_id": ["f18cc76f-82aa-4ad7-b8ce-5737733ee104"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-968-01)", "package_ndc": "65862-968-01", "marketing_start_date": "20160915"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-968-30)", "package_ndc": "65862-968-30", "marketing_start_date": "20160915"}], "brand_name": "ESZOPICLONE", "product_id": "65862-968_a39aa520-c8ad-4f39-ad71-04a839474b5b", "dosage_form": "TABLET, FILM COATED", "product_ndc": "65862-968", "dea_schedule": "CIV", "generic_name": "ESZOPICLONE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ESZOPICLONE", "active_ingredients": [{"name": "ESZOPICLONE", "strength": "2 mg/1"}], "application_number": "ANDA208451", "marketing_category": "ANDA", "marketing_start_date": "20160915", "listing_expiration_date": "20261231"}