entacapone

Generic: entacapone

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name entacapone
Generic Name entacapone
Labeler macleods pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

entacapone 200 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-260
Product ID 33342-260_afea8920-bab9-4c57-b1c7-56def3456fa7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207210
Listing Expiration 2026-12-31
Marketing Start 2017-06-06

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 33342260
Hyphenated Format 33342-260

Supplemental Identifiers

RxCUI
317094
UPC
0333342260154 0333342260116
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 ANDA207210 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (33342-260-11)
  • 500 TABLET in 1 BOTTLE (33342-260-15)
source: ndc

Packages (2)

33342-260-11 100 TABLET in 1 BOTTLE (33342-260-11) 33342-260-15 500 TABLET in 1 BOTTLE (33342-260-15)

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": "afea8920-bab9-4c57-b1c7-56def3456fa7", "openfda": {"nui": ["N0000175756", "N0000175757"], "upc": ["0333342260154", "0333342260116"], "unii": ["4975G9NM6T"], "rxcui": ["317094"], "spl_set_id": ["56327e32-3b06-4144-91a0-bb1908842e33"], "pharm_class_epc": ["Catechol-O-Methyltransferase Inhibitor [EPC]"], "pharm_class_moa": ["Catechol O-Methyltransferase Inhibitors [MoA]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (33342-260-11)", "package_ndc": "33342-260-11", "marketing_start_date": "20170606"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (33342-260-15)", "package_ndc": "33342-260-15", "marketing_start_date": "20170606"}], "brand_name": "Entacapone", "product_id": "33342-260_afea8920-bab9-4c57-b1c7-56def3456fa7", "dosage_form": "TABLET", "pharm_class": ["Catechol O-Methyltransferase Inhibitors [MoA]", "Catechol-O-Methyltransferase Inhibitor [EPC]"], "product_ndc": "33342-260", "generic_name": "Entacapone", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Entacapone", "active_ingredients": [{"name": "ENTACAPONE", "strength": "200 mg/1"}], "application_number": "ANDA207210", "marketing_category": "ANDA", "marketing_start_date": "20170606", "listing_expiration_date": "20261231"}