entacapone

Generic: entacapone

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name entacapone
Generic Name entacapone
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

entacapone 200 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-007
Product ID 47335-007_5330dfe5-b7e1-4813-bf9f-b3e932e61796
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020796
Listing Expiration 2026-12-31
Marketing Start 2013-04-01

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 47335007
Hyphenated Format 47335-007

Supplemental Identifiers

RxCUI
317094
UNII
4975G9NM6T
NUI
N0000175756 N0000175757

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 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 (47335-007-88)
source: ndc

Packages (1)

47335-007-88 100 TABLET, FILM COATED in 1 BOTTLE (47335-007-88)

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": "5330dfe5-b7e1-4813-bf9f-b3e932e61796", "openfda": {"nui": ["N0000175756", "N0000175757"], "unii": ["4975G9NM6T"], "rxcui": ["317094"], "spl_set_id": ["205522fb-bb0e-414e-a413-a08bef727653"], "pharm_class_epc": ["Catechol-O-Methyltransferase Inhibitor [EPC]"], "pharm_class_moa": ["Catechol O-Methyltransferase Inhibitors [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (47335-007-88)", "package_ndc": "47335-007-88", "marketing_start_date": "20130401"}], "brand_name": "Entacapone", "product_id": "47335-007_5330dfe5-b7e1-4813-bf9f-b3e932e61796", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Catechol O-Methyltransferase Inhibitors [MoA]", "Catechol-O-Methyltransferase Inhibitor [EPC]"], "product_ndc": "47335-007", "generic_name": "Entacapone", "labeler_name": "Sun Pharmaceutical Industries, 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": "20130401", "listing_expiration_date": "20261231"}