eszopiclone

Generic: eszopiclone

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

eszopiclone 1 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-299
Product ID 33342-299_66cfec66-191e-4af9-a623-8464417fab6d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202929
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2015-01-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342299
Hyphenated Format 33342-299

Supplemental Identifiers

RxCUI
485440 485442 485465
UPC
0333342300119 0333342299079 0333342301116
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 ANDA202929 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (33342-299-07)
  • 100 TABLET, FILM COATED in 1 BOTTLE (33342-299-11)
  • 10 BLISTER PACK in 1 CARTON (33342-299-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 1000 TABLET, FILM COATED in 1 BOTTLE (33342-299-44)
source: ndc

Packages (4)

33342-299-07 30 TABLET, FILM COATED in 1 BOTTLE (33342-299-07) 33342-299-11 100 TABLET, FILM COATED in 1 BOTTLE (33342-299-11) 33342-299-12 10 BLISTER PACK in 1 CARTON (33342-299-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK 33342-299-44 1000 TABLET, FILM COATED in 1 BOTTLE (33342-299-44)

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": "66cfec66-191e-4af9-a623-8464417fab6d", "openfda": {"upc": ["0333342300119", "0333342299079", "0333342301116"], "unii": ["UZX80K71OE"], "rxcui": ["485440", "485442", "485465"], "spl_set_id": ["12593790-e72f-45b1-8895-987cdd075134"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (33342-299-07)", "package_ndc": "33342-299-07", "marketing_start_date": "20150131"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (33342-299-11)", "package_ndc": "33342-299-11", "marketing_start_date": "20150131"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-299-12)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "33342-299-12", "marketing_start_date": "20150131"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (33342-299-44)", "package_ndc": "33342-299-44", "marketing_start_date": "20150131"}], "brand_name": "Eszopiclone", "product_id": "33342-299_66cfec66-191e-4af9-a623-8464417fab6d", "dosage_form": "TABLET, FILM COATED", "product_ndc": "33342-299", "dea_schedule": "CIV", "generic_name": "Eszopiclone", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eszopiclone", "active_ingredients": [{"name": "ESZOPICLONE", "strength": "1 mg/1"}], "application_number": "ANDA202929", "marketing_category": "ANDA", "marketing_start_date": "20150131", "listing_expiration_date": "20261231"}