eszopiclone

Generic: eszopiclone

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

Drug Facts

Product Profile

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

eszopiclone 3 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-5539
Product ID 0093-5539_efcf4106-ac0a-4f8b-bcd0-743e45e66924
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091169
DEA Schedule civ
Marketing Start 2014-04-14
Marketing End 2027-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00935539
Hyphenated Format 0093-5539

Supplemental Identifiers

RxCUI
485440 485442 485465
UPC
0300935538013 0300935539010 0300935537566
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 ANDA091169 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (0093-5539-01)
source: ndc

Packages (1)

0093-5539-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-5539-01)

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": "efcf4106-ac0a-4f8b-bcd0-743e45e66924", "openfda": {"upc": ["0300935538013", "0300935539010", "0300935537566"], "unii": ["UZX80K71OE"], "rxcui": ["485440", "485442", "485465"], "spl_set_id": ["2435e2f1-bc52-488f-80e9-f1758e354aae"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0093-5539-01)", "package_ndc": "0093-5539-01", "marketing_end_date": "20270228", "marketing_start_date": "20140414"}], "brand_name": "Eszopiclone", "product_id": "0093-5539_efcf4106-ac0a-4f8b-bcd0-743e45e66924", "dosage_form": "TABLET, FILM COATED", "product_ndc": "0093-5539", "dea_schedule": "CIV", "generic_name": "Eszopiclone", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eszopiclone", "active_ingredients": [{"name": "ESZOPICLONE", "strength": "3 mg/1"}], "application_number": "ANDA091169", "marketing_category": "ANDA", "marketing_end_date": "20270228", "marketing_start_date": "20140414"}