eszopiclone

Generic: eszopiclone

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

Drug Facts

Product Profile

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

eszopiclone 3 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-7169
Product ID 68788-7169_99eafec4-1437-4b07-ac52-9bd24db7aa9f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202929
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2018-06-11

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687887169
Hyphenated Format 68788-7169

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
  • 10 TABLET, FILM COATED in 1 BOTTLE (68788-7169-1)
  • 20 TABLET, FILM COATED in 1 BOTTLE (68788-7169-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-7169-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-7169-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-7169-9)
source: ndc

Packages (5)

68788-7169-1 10 TABLET, FILM COATED in 1 BOTTLE (68788-7169-1) 68788-7169-2 20 TABLET, FILM COATED in 1 BOTTLE (68788-7169-2) 68788-7169-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-7169-3) 68788-7169-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-7169-6) 68788-7169-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-7169-9)

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": "99eafec4-1437-4b07-ac52-9bd24db7aa9f", "openfda": {"unii": ["UZX80K71OE"], "rxcui": ["485465"], "spl_set_id": ["2b5b4fbb-9b86-46c6-9508-37d3d9806dec"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (68788-7169-1)", "package_ndc": "68788-7169-1", "marketing_start_date": "20180611"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (68788-7169-2)", "package_ndc": "68788-7169-2", "marketing_start_date": "20180611"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-7169-3)", "package_ndc": "68788-7169-3", "marketing_start_date": "20180611"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-7169-6)", "package_ndc": "68788-7169-6", "marketing_start_date": "20180611"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-7169-9)", "package_ndc": "68788-7169-9", "marketing_start_date": "20180611"}], "brand_name": "Eszopiclone", "product_id": "68788-7169_99eafec4-1437-4b07-ac52-9bd24db7aa9f", "dosage_form": "TABLET, FILM COATED", "product_ndc": "68788-7169", "dea_schedule": "CIV", "generic_name": "Eszopiclone", "labeler_name": "Preferred Pharmaceuticals 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": "20180611", "listing_expiration_date": "20261231"}