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 72789-067
Product ID 72789-067_403149fb-ab38-8d11-e063-6294a90a14a9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208451
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2016-09-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789067
Hyphenated Format 72789-067

Supplemental Identifiers

RxCUI
485465
UPC
0372789067308
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 ANDA208451 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-067-30)
source: ndc

Packages (1)

72789-067-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-067-30)

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": "403149fb-ab38-8d11-e063-6294a90a14a9", "openfda": {"upc": ["0372789067308"], "unii": ["UZX80K71OE"], "rxcui": ["485465"], "spl_set_id": ["bb972d36-4b2c-45ae-8504-3a16d352dd8b"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-067-30)", "package_ndc": "72789-067-30", "marketing_start_date": "20200326"}], "brand_name": "ESZOPICLONE", "product_id": "72789-067_403149fb-ab38-8d11-e063-6294a90a14a9", "dosage_form": "TABLET, FILM COATED", "product_ndc": "72789-067", "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": "ANDA208451", "marketing_category": "ANDA", "marketing_start_date": "20160915", "listing_expiration_date": "20261231"}