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 ID: 64406-005_27904d47-ed5f-493b-80ca-cdde4fd01073
• NDC: 64406-005
• Product Type: Human Prescription Drug
• Proprietary Name: Tecfidera
• Generic Name: Dimethyl Fumarate
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2013-03-27
• Marketing Category: NDA / NDA
• Application Number: NDA204063
• Labeler Name: Biogen Inc.
• Substance Name: DIMETHYL FUMARATE
• Active Ingredient Strength: 120 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 64406-005-01

1 BOTTLE, PLASTIC in 1 CARTON (64406-005-01) > 14 CAPSULE in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2013-03-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64406-005-01 [64406000501]

Tecfidera CAPSULE

• Marketing Category: NDA
• Application Number: NDA204063
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-03-27

Drug Details

Active Ingredients

Ingredient	Strength
DIMETHYL FUMARATE	120 mg/1

OpenFDA Data

• SPL SET ID: 665d7e74-036c-5f68-5b67-ab84b9b49151
• Manufacturer:
  • Biogen Inc.
• UNII:
  • FO2303MNI2
• 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"

NDC	Brand Name	Generic Name
64406-005	Tecfidera	Tecfidera
64406-007	Tecfidera	Tecfidera
64406-006	Tecfidera	Tecfidera
0093-9218	dimethyl fumarate	dimethyl fumarate
0093-9219	dimethyl fumarate	dimethyl fumarate
0378-0396	Dimethyl fumarate	Dimethyl fumarate
0378-0399	Dimethyl fumarate	Dimethyl fumarate
16729-416	DIMETHYL FUMARATE	DIMETHYL FUMARATE
16729-417	DIMETHYL FUMARATE	DIMETHYL FUMARATE
16729-418	DIMETHYL FUMARATE	DIMETHYL FUMARATE
24979-127	dimethyl fumarate	dimethyl fumarate
24979-128	dimethyl fumarate	dimethyl fumarate
24979-129	dimethyl fumarate	dimethyl fumarate
31722-657	Dimethyl Fumarate	Dimethyl Fumarate
31722-658	Dimethyl Fumarate	Dimethyl Fumarate
31722-680	Dimethyl Fumarate	Dimethyl Fumarate
43547-024	DIMETHYL FUMARATE	dimethyl fumarate
43547-025	DIMETHYL FUMARATE	dimethyl fumarate
43598-429	Dimethyl Fumarate	Dimethyl fumarate
43598-430	Dimethyl Fumarate	Dimethyl fumarate
50090-5288	Dimethyl Fumarate	Dimethyl Fumarate
51407-441	dimethyl fumarate	dimethyl fumarate