eszopiclone

Generic: eszopiclone

Labeler: glenmark pharmaceuticals inc. usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eszopiclone
Generic Name eszopiclone
Labeler glenmark pharmaceuticals inc. usa
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

eszopiclone 2 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc. USA

Identifiers & Regulatory

Product NDC 68462-383
Product ID 68462-383_59fb9200-74d0-472d-a4c7-96c9a4ded89c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091166
DEA Schedule civ
Listing Expiration 2027-12-31
Marketing Start 2014-04-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462383
Hyphenated Format 68462-383

Supplemental Identifiers

RxCUI
485440 485442 485465
UPC
0368462384015 0368462383018 0368462382011
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 ANDA091166 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68462-383-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (68462-383-10)
source: ndc

Packages (2)

68462-383-01 100 TABLET, FILM COATED in 1 BOTTLE (68462-383-01) 68462-383-10 1000 TABLET, FILM COATED in 1 BOTTLE (68462-383-10)

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": "59fb9200-74d0-472d-a4c7-96c9a4ded89c", "openfda": {"upc": ["0368462384015", "0368462383018", "0368462382011"], "unii": ["UZX80K71OE"], "rxcui": ["485440", "485442", "485465"], "spl_set_id": ["584dc66c-063a-4552-a056-74b811e2bc80"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc. USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68462-383-01)", "package_ndc": "68462-383-01", "marketing_start_date": "20140415"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (68462-383-10)", "package_ndc": "68462-383-10", "marketing_start_date": "20140415"}], "brand_name": "Eszopiclone", "product_id": "68462-383_59fb9200-74d0-472d-a4c7-96c9a4ded89c", "dosage_form": "TABLET, FILM COATED", "product_ndc": "68462-383", "dea_schedule": "CIV", "generic_name": "Eszopiclone", "labeler_name": "Glenmark Pharmaceuticals Inc. USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eszopiclone", "active_ingredients": [{"name": "ESZOPICLONE", "strength": "2 mg/1"}], "application_number": "ANDA091166", "marketing_category": "ANDA", "marketing_start_date": "20140415", "listing_expiration_date": "20271231"}