entacapone

Generic: entacapone

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name entacapone
Generic Name entacapone
Labeler sandoz inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

entacapone 200 mg/1

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-5578
Product ID 0781-5578_a5584d62-a95a-4a17-8c37-0f0bc72b9bb5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020796
Listing Expiration 2026-12-31
Marketing Start 2014-06-04

Pharmacologic Class

Established (EPC)
catechol-o-methyltransferase inhibitor [epc]
Mechanism of Action
catechol o-methyltransferase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07815578
Hyphenated Format 0781-5578

Supplemental Identifiers

RxCUI
317094
UNII
4975G9NM6T
NUI
N0000175756 N0000175757

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 entacapone (source: ndc)
Generic Name entacapone (source: ndc)
Application Number NDA020796 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (0781-5578-01)
source: ndc

Packages (1)

0781-5578-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-5578-01)

Ingredients (1)

entacapone (200 mg/1)

Linked Drug Pages (1)

Entacapone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a5584d62-a95a-4a17-8c37-0f0bc72b9bb5", "openfda": {"nui": ["N0000175756", "N0000175757"], "unii": ["4975G9NM6T"], "rxcui": ["317094"], "spl_set_id": ["ad4b6d79-efd3-4c43-b4dc-5afdacf939a4"], "pharm_class_epc": ["Catechol-O-Methyltransferase Inhibitor [EPC]"], "pharm_class_moa": ["Catechol O-Methyltransferase Inhibitors [MoA]"], "manufacturer_name": ["Sandoz Inc"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0781-5578-01)", "package_ndc": "0781-5578-01", "marketing_start_date": "20140604"}], "brand_name": "Entacapone", "product_id": "0781-5578_a5584d62-a95a-4a17-8c37-0f0bc72b9bb5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Catechol O-Methyltransferase Inhibitors [MoA]", "Catechol-O-Methyltransferase Inhibitor [EPC]"], "product_ndc": "0781-5578", "generic_name": "Entacapone", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Entacapone", "active_ingredients": [{"name": "ENTACAPONE", "strength": "200 mg/1"}], "application_number": "NDA020796", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20140604", "listing_expiration_date": "20261231"}