eszopiclone

Generic: eszopiclone

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eszopiclone
Generic Name eszopiclone
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

eszopiclone 1 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-586
Product ID 47335-586_95e952a3-5a7d-4b4c-9ac8-b5256a4371c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091103
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2014-04-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335586
Hyphenated Format 47335-586

Supplemental Identifiers

RxCUI
485440 485442 485465
UPC
0347335586831
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 ANDA091103 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (47335-586-08)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (47335-586-18)
  • 30 TABLET, FILM COATED in 1 BOTTLE (47335-586-83)
  • 100 TABLET, FILM COATED in 1 BOTTLE (47335-586-88)
source: ndc

Packages (4)

47335-586-08 100 TABLET, FILM COATED in 1 BOTTLE (47335-586-08) 47335-586-18 1000 TABLET, FILM COATED in 1 BOTTLE (47335-586-18) 47335-586-83 30 TABLET, FILM COATED in 1 BOTTLE (47335-586-83) 47335-586-88 100 TABLET, FILM COATED in 1 BOTTLE (47335-586-88)

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": "95e952a3-5a7d-4b4c-9ac8-b5256a4371c3", "openfda": {"upc": ["0347335586831"], "unii": ["UZX80K71OE"], "rxcui": ["485440", "485442", "485465"], "spl_set_id": ["8bb1965e-7845-4c5b-b021-38e251303d68"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (47335-586-08)", "package_ndc": "47335-586-08", "marketing_start_date": "20140415"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (47335-586-18)", "package_ndc": "47335-586-18", "marketing_start_date": "20140415"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (47335-586-83)", "package_ndc": "47335-586-83", "marketing_start_date": "20140415"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (47335-586-88)", "package_ndc": "47335-586-88", "marketing_start_date": "20140415"}], "brand_name": "ESZOPICLONE", "product_id": "47335-586_95e952a3-5a7d-4b4c-9ac8-b5256a4371c3", "dosage_form": "TABLET, FILM COATED", "product_ndc": "47335-586", "dea_schedule": "CIV", "generic_name": "ESZOPICLONE", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ESZOPICLONE", "active_ingredients": [{"name": "ESZOPICLONE", "strength": "1 mg/1"}], "application_number": "ANDA091103", "marketing_category": "ANDA", "marketing_start_date": "20140415", "listing_expiration_date": "20261231"}