lunesta

Generic: eszopiclone

Labeler: waylis therapeutics llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lunesta
Generic Name eszopiclone
Labeler waylis therapeutics llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

eszopiclone 2 mg/1

Manufacturer
Waylis Therapeutics LLC

Identifiers & Regulatory

Product NDC 80725-011
Product ID 80725-011_4a1b20fc-a41d-41dd-a557-fa9333bb5c3b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021476
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-08-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80725011
Hyphenated Format 80725-011

Supplemental Identifiers

RxCUI
485440 485442 485465 540407 540409 540411
UPC
0380725010301 0380725012305 0380725011308
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 lunesta (source: ndc)
Generic Name eszopiclone (source: ndc)
Application Number NDA021476 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE (80725-011-30)
source: ndc

Packages (1)

80725-011-30 30 TABLET, COATED in 1 BOTTLE (80725-011-30)

Ingredients (1)

eszopiclone (2 mg/1)

Linked Drug Pages (1)

Lunesta ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4a1b20fc-a41d-41dd-a557-fa9333bb5c3b", "openfda": {"upc": ["0380725010301", "0380725012305", "0380725011308"], "unii": ["UZX80K71OE"], "rxcui": ["485440", "485442", "485465", "540407", "540409", "540411"], "spl_set_id": ["3821f4b7-a3c8-4920-ba80-18aa96532c09"], "manufacturer_name": ["Waylis Therapeutics LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (80725-011-30)", "package_ndc": "80725-011-30", "marketing_start_date": "20230815"}], "brand_name": "Lunesta", "product_id": "80725-011_4a1b20fc-a41d-41dd-a557-fa9333bb5c3b", "dosage_form": "TABLET, COATED", "product_ndc": "80725-011", "dea_schedule": "CIV", "generic_name": "ESZOPICLONE", "labeler_name": "Waylis Therapeutics LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lunesta", "active_ingredients": [{"name": "ESZOPICLONE", "strength": "2 mg/1"}], "application_number": "NDA021476", "marketing_category": "NDA", "marketing_start_date": "20230815", "listing_expiration_date": "20261231"}