NDC 64406-005

Tecfidera

Dimethyl Fumarate

Tecfidera is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Biogen Inc.. The primary component is Dimethyl Fumarate.

Product ID64406-005_27904d47-ed5f-493b-80ca-cdde4fd01073
NDC64406-005
Product TypeHuman Prescription Drug
Proprietary NameTecfidera
Generic NameDimethyl Fumarate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2013-03-27
Marketing CategoryNDA / NDA
Application NumberNDA204063
Labeler NameBiogen Inc.
Substance NameDIMETHYL FUMARATE
Active Ingredient Strength120 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 64406-005-01

1 BOTTLE, PLASTIC in 1 CARTON (64406-005-01) > 14 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Start Date2013-03-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64406-005-01 [64406000501]

Tecfidera CAPSULE
Marketing CategoryNDA
Application NumberNDA204063
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-03-27

Drug Details

Active Ingredients

IngredientStrength
DIMETHYL FUMARATE120 mg/1

OpenFDA Data

SPL SET ID:665d7e74-036c-5f68-5b67-ab84b9b49151
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1373497
  • 1373493
  • 1373491
  • 1373498
  • 1373489
  • 1373483
  • UPC Code
  • 0364406005107
  • 0364406005084
  • 0364406005015
  • NDC Crossover Matching brand name "Tecfidera" or generic name "Dimethyl Fumarate"

    NDCBrand NameGeneric Name
    64406-005TecfideraTecfidera
    64406-007TecfideraTecfidera
    64406-006TecfideraTecfidera
    0093-9218dimethyl fumaratedimethyl fumarate
    0093-9219dimethyl fumaratedimethyl fumarate
    0378-0396Dimethyl fumarateDimethyl fumarate
    0378-0399Dimethyl fumarateDimethyl fumarate
    16729-416DIMETHYL FUMARATEDIMETHYL FUMARATE
    16729-417DIMETHYL FUMARATEDIMETHYL FUMARATE
    16729-418DIMETHYL FUMARATEDIMETHYL FUMARATE
    24979-127dimethyl fumaratedimethyl fumarate
    24979-128dimethyl fumaratedimethyl fumarate
    24979-129dimethyl fumaratedimethyl fumarate
    31722-657Dimethyl FumarateDimethyl Fumarate
    31722-658Dimethyl FumarateDimethyl Fumarate
    31722-680Dimethyl FumarateDimethyl Fumarate
    43547-024DIMETHYL FUMARATEdimethyl fumarate
    43547-025DIMETHYL FUMARATEdimethyl fumarate
    43598-429Dimethyl FumarateDimethyl fumarate
    43598-430Dimethyl FumarateDimethyl fumarate
    50090-5288Dimethyl FumarateDimethyl Fumarate
    51407-441dimethyl fumaratedimethyl fumarate

    Trademark Results [Tecfidera]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TECFIDERA
    TECFIDERA
    85922322 4465265 Live/Registered
    Biogen Idec MA Inc.
    2013-05-03
    TECFIDERA
    TECFIDERA
    85922291 4542053 Live/Registered
    Biogen Idec MA Inc.
    2013-05-03
    TECFIDERA
    TECFIDERA
    85671265 4365941 Live/Registered
    BIOGEN MA INC.
    2012-07-09

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