eszopiclone

Generic: eszopiclone

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

eszopiclone 3 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-795
Product ID 43063-795_415b59ae-84e5-550f-e063-6294a90af226
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091124
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 43063795
Hyphenated Format 43063-795

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 ANDA091124 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-795-30)
source: ndc

Packages (1)

43063-795-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-795-30)

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": "415b59ae-84e5-550f-e063-6294a90af226", "openfda": {"unii": ["UZX80K71OE"], "rxcui": ["485465"], "spl_set_id": ["4832cfbf-a540-46af-bb7d-3ba8e6bc783e"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-795-30)", "package_ndc": "43063-795-30", "marketing_start_date": "20171009"}], "brand_name": "Eszopiclone", "product_id": "43063-795_415b59ae-84e5-550f-e063-6294a90af226", "dosage_form": "TABLET, FILM COATED", "product_ndc": "43063-795", "dea_schedule": "CIV", "generic_name": "Eszopiclone", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eszopiclone", "active_ingredients": [{"name": "ESZOPICLONE", "strength": "3 mg/1"}], "application_number": "ANDA091124", "marketing_category": "ANDA", "marketing_start_date": "20140415", "listing_expiration_date": "20261231"}