eszopiclone

Generic: eszopiclone

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

eszopiclone 2 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-353
Product ID 76420-353_4ca4de13-a880-98bf-e063-6294a90aa9f2
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 76420353
Hyphenated Format 76420-353

Supplemental Identifiers

UNII
UZX80K71OE

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
  • 1000 TABLET, FILM COATED in 1 BOTTLE (76420-353-00)
  • 100 TABLET, FILM COATED in 1 BOTTLE (76420-353-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (76420-353-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (76420-353-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76420-353-90)
source: ndc

Packages (5)

76420-353-00 1000 TABLET, FILM COATED in 1 BOTTLE (76420-353-00) 76420-353-01 100 TABLET, FILM COATED in 1 BOTTLE (76420-353-01) 76420-353-30 30 TABLET, FILM COATED in 1 BOTTLE (76420-353-30) 76420-353-60 60 TABLET, FILM COATED in 1 BOTTLE (76420-353-60) 76420-353-90 90 TABLET, FILM COATED in 1 BOTTLE (76420-353-90)

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": "4ca4de13-a880-98bf-e063-6294a90aa9f2", "openfda": {"unii": ["UZX80K71OE"], "spl_set_id": ["838559f7-4b69-4831-bf50-ab37c6c24c2b"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (76420-353-00)", "package_ndc": "76420-353-00", "marketing_start_date": "20250522"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (76420-353-01)", "package_ndc": "76420-353-01", "marketing_start_date": "20250522"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76420-353-30)", "package_ndc": "76420-353-30", "marketing_start_date": "20250522"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (76420-353-60)", "package_ndc": "76420-353-60", "marketing_start_date": "20250522"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76420-353-90)", "package_ndc": "76420-353-90", "marketing_start_date": "20250522"}], "brand_name": "Eszopiclone", "product_id": "76420-353_4ca4de13-a880-98bf-e063-6294a90aa9f2", "dosage_form": "TABLET, FILM COATED", "product_ndc": "76420-353", "dea_schedule": "CIV", "generic_name": "Eszopiclone", "labeler_name": "Asclemed USA, Inc.", "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"}