NDC 49884-254

Tolcapone

Tolcapone

Tolcapone is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is Tolcapone.

Product ID49884-254_75578ac3-ecaa-4a4e-b7ef-94246a6f3199
NDC49884-254
Product TypeHuman Prescription Drug
Proprietary NameTolcapone
Generic NameTolcapone
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2015-01-06
Marketing CategoryANDA / ANDA
Application NumberANDA204584
Labeler NamePar Pharmaceutical, Inc.
Substance NameTOLCAPONE
Active Ingredient Strength100 mg/1
Pharm ClassesCatechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 49884-254-09

90 TABLET, COATED in 1 BOTTLE (49884-254-09)
Marketing Start Date2015-01-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49884-254-09 [49884025409]

Tolcapone TABLET, COATED
Marketing CategoryANDA
Application NumberANDA204584
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-06

Drug Details

Active Ingredients

IngredientStrength
TOLCAPONE100 mg/1

OpenFDA Data

SPL SET ID:cad137fb-d18a-4286-94cf-7e79cdeea3f6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200220
  • UPC Code
  • 0349884254094
  • Pharmacological Class

    • Catechol O-Methyltransferase Inhibitors [MoA]
    • Catechol-O-Methyltransferase Inhibitor [EPC]

    NDC Crossover Matching brand name "Tolcapone" or generic name "Tolcapone"

    NDCBrand NameGeneric Name
    49884-254TolcaponeTolcapone
    50742-193TOLCAPONEtolcapone
    68682-938TolcaponeTolcapone
    0187-0938TasmarTolcapone

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