eszopiclone

Generic: eszopiclone

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eszopiclone
Generic Name eszopiclone
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

eszopiclone 2 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-076
Product ID 82804-076_e32746a8-6440-4b0a-a445-4467cf0329d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091166
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2014-04-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804076
Hyphenated Format 82804-076

Supplemental Identifiers

RxCUI
485442
UPC
0382804076307
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 (82804-076-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (82804-076-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (82804-076-90)
source: ndc

Packages (3)

82804-076-30 30 TABLET, FILM COATED in 1 BOTTLE (82804-076-30) 82804-076-60 60 TABLET, FILM COATED in 1 BOTTLE (82804-076-60) 82804-076-90 90 TABLET, FILM COATED in 1 BOTTLE (82804-076-90)

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": "e32746a8-6440-4b0a-a445-4467cf0329d5", "openfda": {"upc": ["0382804076307"], "unii": ["UZX80K71OE"], "rxcui": ["485442"], "spl_set_id": ["e32746a8-6440-4b0a-a445-4467cf0329d5"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (82804-076-30)", "package_ndc": "82804-076-30", "marketing_start_date": "20240221"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (82804-076-60)", "package_ndc": "82804-076-60", "marketing_start_date": "20240221"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (82804-076-90)", "package_ndc": "82804-076-90", "marketing_start_date": "20240221"}], "brand_name": "Eszopiclone", "product_id": "82804-076_e32746a8-6440-4b0a-a445-4467cf0329d5", "dosage_form": "TABLET, FILM COATED", "product_ndc": "82804-076", "dea_schedule": "CIV", "generic_name": "Eszopiclone", "labeler_name": "Proficient Rx LP", "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": "20261231"}