eszopiclone

Generic: eszopiclone

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

Drug Facts

Product Profile

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

eszopiclone 1 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-5270
Product ID 0378-5270_850bc29d-2353-4e1f-bfe4-0811eb79000f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091151
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2013-03-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03785270
Hyphenated Format 0378-5270

Supplemental Identifiers

RxCUI
485440 485442 485465
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 eszopiclone (source: ndc)
Generic Name eszopiclone (source: ndc)
Application Number ANDA091151 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5270-01)
source: ndc

Packages (1)

0378-5270-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5270-01)

Ingredients (1)

eszopiclone (1 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": "850bc29d-2353-4e1f-bfe4-0811eb79000f", "openfda": {"unii": ["UZX80K71OE"], "rxcui": ["485440", "485442", "485465"], "spl_set_id": ["5469cc59-78f9-447a-9c33-12553bb4073d"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5270-01)", "package_ndc": "0378-5270-01", "marketing_start_date": "20130326"}], "brand_name": "Eszopiclone", "product_id": "0378-5270_850bc29d-2353-4e1f-bfe4-0811eb79000f", "dosage_form": "TABLET, FILM COATED", "product_ndc": "0378-5270", "dea_schedule": "CIV", "generic_name": "eszopiclone", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eszopiclone", "active_ingredients": [{"name": "ESZOPICLONE", "strength": "1 mg/1"}], "application_number": "ANDA091151", "marketing_category": "ANDA", "marketing_start_date": "20130326", "listing_expiration_date": "20261231"}