entacapone

Generic: entacapone

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name entacapone
Generic Name entacapone
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

entacapone 200 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-654
Product ID 65862-654_54466878-6cce-44e7-8188-27b6091a5d15
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203437
Listing Expiration 2026-12-31
Marketing Start 2015-06-19

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 65862654
Hyphenated Format 65862-654

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 ANDA203437 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-654-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-654-99)
source: ndc

Packages (2)

65862-654-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-654-01) 65862-654-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-654-99)

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": "54466878-6cce-44e7-8188-27b6091a5d15", "openfda": {"nui": ["N0000175756", "N0000175757"], "unii": ["4975G9NM6T"], "rxcui": ["317094"], "spl_set_id": ["d9cc1327-5474-4136-970a-ec40c41975b2"], "pharm_class_epc": ["Catechol-O-Methyltransferase Inhibitor [EPC]"], "pharm_class_moa": ["Catechol O-Methyltransferase Inhibitors [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-654-01)", "package_ndc": "65862-654-01", "marketing_start_date": "20150619"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-654-99)", "package_ndc": "65862-654-99", "marketing_start_date": "20150619"}], "brand_name": "Entacapone", "product_id": "65862-654_54466878-6cce-44e7-8188-27b6091a5d15", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Catechol O-Methyltransferase Inhibitors [MoA]", "Catechol-O-Methyltransferase Inhibitor [EPC]"], "product_ndc": "65862-654", "generic_name": "Entacapone", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Entacapone", "active_ingredients": [{"name": "ENTACAPONE", "strength": "200 mg/1"}], "application_number": "ANDA203437", "marketing_category": "ANDA", "marketing_start_date": "20150619", "listing_expiration_date": "20261231"}