eszopiclone

Generic: eszopiclone

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

eszopiclone 3 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3576
Product ID 70518-3576_3ff0203e-da0b-cc72-e063-6294a90a0dc2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202929
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2022-11-10

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183576
Hyphenated Format 70518-3576

Supplemental Identifiers

RxCUI
485465
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 ANDA202929 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3576-0)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3576-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3576-2)
source: ndc

Packages (3)

70518-3576-0 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3576-0) 70518-3576-1 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3576-1) 70518-3576-2 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3576-2)

Ingredients (1)

eszopiclone (3 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": "3ff0203e-da0b-cc72-e063-6294a90a0dc2", "openfda": {"unii": ["UZX80K71OE"], "rxcui": ["485465"], "spl_set_id": ["61fd4655-060f-4393-a610-019d8b127058"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3576-0)", "package_ndc": "70518-3576-0", "marketing_start_date": "20221110"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3576-1)", "package_ndc": "70518-3576-1", "marketing_start_date": "20250617"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3576-2)", "package_ndc": "70518-3576-2", "marketing_start_date": "20250929"}], "brand_name": "Eszopiclone", "product_id": "70518-3576_3ff0203e-da0b-cc72-e063-6294a90a0dc2", "dosage_form": "TABLET, FILM COATED", "product_ndc": "70518-3576", "dea_schedule": "CIV", "generic_name": "Eszopiclone", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eszopiclone", "active_ingredients": [{"name": "ESZOPICLONE", "strength": "3 mg/1"}], "application_number": "ANDA202929", "marketing_category": "ANDA", "marketing_start_date": "20221110", "listing_expiration_date": "20261231"}