eszopiclone

Generic: eszopiclone

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

Drug Facts

Product Profile

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

eszopiclone 2 mg/1

Manufacturer
Preferred Pharmaceuticals Inc. USA

Identifiers & Regulatory

Product NDC 68788-8077
Product ID 68788-8077_8774eead-9146-4e07-acf7-4b6ab3bc1c22
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091166
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2021-09-03

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888077
Hyphenated Format 68788-8077

Supplemental Identifiers

RxCUI
485442
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
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8077-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8077-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8077-9)
source: ndc

Packages (3)

68788-8077-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8077-3) 68788-8077-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8077-6) 68788-8077-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8077-9)

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": "8774eead-9146-4e07-acf7-4b6ab3bc1c22", "openfda": {"unii": ["UZX80K71OE"], "rxcui": ["485442"], "spl_set_id": ["f924836c-bf05-4d7e-b448-bb189a46045b"], "manufacturer_name": ["Preferred Pharmaceuticals Inc. USA"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8077-3)", "package_ndc": "68788-8077-3", "marketing_start_date": "20210903"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8077-6)", "package_ndc": "68788-8077-6", "marketing_start_date": "20210903"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8077-9)", "package_ndc": "68788-8077-9", "marketing_start_date": "20210903"}], "brand_name": "Eszopiclone", "product_id": "68788-8077_8774eead-9146-4e07-acf7-4b6ab3bc1c22", "dosage_form": "TABLET, FILM COATED", "product_ndc": "68788-8077", "dea_schedule": "CIV", "generic_name": "Eszopiclone", "labeler_name": "Preferred Pharmaceuticals Inc. USA", "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": "20210903", "listing_expiration_date": "20261231"}