tolcapone

Generic: tolcapone

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tolcapone
Generic Name tolcapone
Labeler ingenus pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tolcapone 100 mg/1

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-193
Product ID 50742-193_b0eeccbf-775d-4ff7-805c-cc176f965198
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208937
Listing Expiration 2026-12-31
Marketing Start 2018-08-21

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 50742193
Hyphenated Format 50742-193

Supplemental Identifiers

RxCUI
200220
UNII
CIF6334OLY
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 tolcapone (source: ndc)
Generic Name tolcapone (source: ndc)
Application Number ANDA208937 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (50742-193-90)
source: ndc

Packages (1)

50742-193-90 90 TABLET in 1 BOTTLE (50742-193-90)

Ingredients (1)

tolcapone (100 mg/1)

Linked Drug Pages (1)

TOLCAPONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b0eeccbf-775d-4ff7-805c-cc176f965198", "openfda": {"nui": ["N0000175756", "N0000175757"], "unii": ["CIF6334OLY"], "rxcui": ["200220"], "spl_set_id": ["d94891be-2fef-4e39-8e35-ab7afe93e78e"], "pharm_class_epc": ["Catechol-O-Methyltransferase Inhibitor [EPC]"], "pharm_class_moa": ["Catechol O-Methyltransferase Inhibitors [MoA]"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (50742-193-90)", "package_ndc": "50742-193-90", "marketing_start_date": "20180821"}], "brand_name": "TOLCAPONE", "product_id": "50742-193_b0eeccbf-775d-4ff7-805c-cc176f965198", "dosage_form": "TABLET", "pharm_class": ["Catechol O-Methyltransferase Inhibitors [MoA]", "Catechol-O-Methyltransferase Inhibitor [EPC]"], "product_ndc": "50742-193", "generic_name": "tolcapone", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TOLCAPONE", "active_ingredients": [{"name": "TOLCAPONE", "strength": "100 mg/1"}], "application_number": "ANDA208937", "marketing_category": "ANDA", "marketing_start_date": "20180821", "listing_expiration_date": "20261231"}