NDC 68682-938

Tolcapone

Tolcapone

Tolcapone is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Oceanside Pharmaceuticals. The primary component is Tolcapone.

Product ID68682-938_9ec63a14-0b6a-47eb-9258-19b6e3cb5b25
NDC68682-938
Product TypeHuman Prescription Drug
Proprietary NameTolcapone
Generic NameTolcapone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2004-07-27
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA020697
Labeler NameOceanside Pharmaceuticals
Substance NameTOLCAPONE
Active Ingredient Strength100 mg/1
Pharm ClassesCatechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68682-938-90

90 TABLET, FILM COATED in 1 BOTTLE (68682-938-90)
Marketing Start Date2004-07-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68682-938-90 [68682093890]

Tolcapone TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA020697
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2004-07-27

Drug Details

Active Ingredients

IngredientStrength
TOLCAPONE100 mg/1

OpenFDA Data

SPL SET ID:dd367eec-359a-4065-b5c3-7c0107c823fe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200220
  • UPC Code
  • 0368682938906
  • Pharmacological Class

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