eszopiclone

Generic: eszopiclone

Labeler: dr. reddy's laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eszopiclone
Generic Name eszopiclone
Labeler dr. reddy's laboratories limited
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

eszopiclone 2 mg/1

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-619
Product ID 55111-619_bf1433f5-bde8-8c67-9ff7-ec5d3ed26581
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091024
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 55111619
Hyphenated Format 55111-619

Supplemental Identifiers

RxCUI
485440 485442 485465
UPC
0355111617013 0355111629306 0355111619017
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 ANDA091024 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (55111-619-01)
  • 500 TABLET, COATED in 1 BOTTLE (55111-619-05)
  • 9 BLISTER PACK in 1 CARTON (55111-619-09) / 10 TABLET, COATED in 1 BLISTER PACK (55111-619-79)
  • 30 TABLET, COATED in 1 BOTTLE (55111-619-30)
  • 90 TABLET, COATED in 1 BOTTLE (55111-619-90)
source: ndc

Packages (5)

55111-619-01 100 TABLET, COATED in 1 BOTTLE (55111-619-01) 55111-619-05 500 TABLET, COATED in 1 BOTTLE (55111-619-05) 55111-619-09 9 BLISTER PACK in 1 CARTON (55111-619-09) / 10 TABLET, COATED in 1 BLISTER PACK (55111-619-79) 55111-619-30 30 TABLET, COATED in 1 BOTTLE (55111-619-30) 55111-619-90 90 TABLET, COATED in 1 BOTTLE (55111-619-90)

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": "bf1433f5-bde8-8c67-9ff7-ec5d3ed26581", "openfda": {"upc": ["0355111617013", "0355111629306", "0355111619017"], "unii": ["UZX80K71OE"], "rxcui": ["485440", "485442", "485465"], "spl_set_id": ["0b363b90-93dc-1fc1-0501-d140dfc762c7"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (55111-619-01)", "package_ndc": "55111-619-01", "marketing_start_date": "20140415"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (55111-619-05)", "package_ndc": "55111-619-05", "marketing_start_date": "20140415"}, {"sample": false, "description": "9 BLISTER PACK in 1 CARTON (55111-619-09)  / 10 TABLET, COATED in 1 BLISTER PACK (55111-619-79)", "package_ndc": "55111-619-09", "marketing_start_date": "20140415"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (55111-619-30)", "package_ndc": "55111-619-30", "marketing_start_date": "20140415"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (55111-619-90)", "package_ndc": "55111-619-90", "marketing_start_date": "20140415"}], "brand_name": "Eszopiclone", "product_id": "55111-619_bf1433f5-bde8-8c67-9ff7-ec5d3ed26581", "dosage_form": "TABLET, COATED", "product_ndc": "55111-619", "dea_schedule": "CIV", "generic_name": "Eszopiclone", "labeler_name": "Dr. Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eszopiclone", "active_ingredients": [{"name": "ESZOPICLONE", "strength": "2 mg/1"}], "application_number": "ANDA091024", "marketing_category": "ANDA", "marketing_start_date": "20140415", "listing_expiration_date": "20261231"}