tolcapone

Generic: tolcapone

Labeler: oceanside pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name tolcapone
Generic Name tolcapone
Labeler oceanside pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tolcapone 100 mg/1

Manufacturer
Oceanside Pharmaceuticals

Identifiers & Regulatory

Product NDC 68682-938
Product ID 68682-938_9ec63a14-0b6a-47eb-9258-19b6e3cb5b25
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020697
Listing Expiration 2026-12-31
Marketing Start 2004-07-27

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 68682938
Hyphenated Format 68682-938

Supplemental Identifiers

RxCUI
200220
UPC
0368682938906
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 NDA020697 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (68682-938-90)
source: ndc

Packages (1)

68682-938-90 90 TABLET, FILM COATED in 1 BOTTLE (68682-938-90)

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": "9ec63a14-0b6a-47eb-9258-19b6e3cb5b25", "openfda": {"nui": ["N0000175756", "N0000175757"], "upc": ["0368682938906"], "unii": ["CIF6334OLY"], "rxcui": ["200220"], "spl_set_id": ["dd367eec-359a-4065-b5c3-7c0107c823fe"], "pharm_class_epc": ["Catechol-O-Methyltransferase Inhibitor [EPC]"], "pharm_class_moa": ["Catechol O-Methyltransferase Inhibitors [MoA]"], "manufacturer_name": ["Oceanside Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68682-938-90)", "package_ndc": "68682-938-90", "marketing_start_date": "20040727"}], "brand_name": "Tolcapone", "product_id": "68682-938_9ec63a14-0b6a-47eb-9258-19b6e3cb5b25", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Catechol O-Methyltransferase Inhibitors [MoA]", "Catechol-O-Methyltransferase Inhibitor [EPC]"], "product_ndc": "68682-938", "generic_name": "Tolcapone", "labeler_name": "Oceanside Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tolcapone", "active_ingredients": [{"name": "TOLCAPONE", "strength": "100 mg/1"}], "application_number": "NDA020697", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20040727", "listing_expiration_date": "20261231"}