entacapone

Generic: entacapone

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name entacapone
Generic Name entacapone
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET
Routes
ORAL
Active Ingredients

entacapone 200 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8298
Product ID 0615-8298_8a8a753b-0535-46cc-9f01-357510f4e9f0
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 06158298
Hyphenated Format 0615-8298

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 ANDA207210 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (0615-8298-39)
source: ndc

Packages (1)

0615-8298-39 30 TABLET in 1 BLISTER PACK (0615-8298-39)

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": "8a8a753b-0535-46cc-9f01-357510f4e9f0", "openfda": {"nui": ["N0000175756", "N0000175757"], "unii": ["4975G9NM6T"], "rxcui": ["317094"], "spl_set_id": ["bff19d15-c57b-4a40-bba4-1e0a85fd09c5"], "pharm_class_epc": ["Catechol-O-Methyltransferase Inhibitor [EPC]"], "pharm_class_moa": ["Catechol O-Methyltransferase Inhibitors [MoA]"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (0615-8298-39)", "package_ndc": "0615-8298-39", "marketing_start_date": "20190701"}], "brand_name": "Entacapone", "product_id": "0615-8298_8a8a753b-0535-46cc-9f01-357510f4e9f0", "dosage_form": "TABLET", "pharm_class": ["Catechol O-Methyltransferase Inhibitors [MoA]", "Catechol-O-Methyltransferase Inhibitor [EPC]"], "product_ndc": "0615-8298", "generic_name": "Entacapone", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "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"}