FDA.reportPublic FDA data

TECFIDERA

Product NDC
64406-005
11-digit product format
644060005
Labeler code
64406
Product ID
64406-005_521e4305-9450-42a4-881b-05946acaa8fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dimethyl fumarate
Dosage form
CAPSULE
Route
ORAL
Labeler
Biogen Inc.
Application
NDA204063
Marketing category
NDA
Marketing start
2013-03-27
Substance
DIMETHYL FUMARATE
Active strength
120 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TECFIDERA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHYL FUMARATE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFO2303MNI2
Rxcui1373483, 1373489, 1373491, 1373493, 1373497, 1373498

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
782c9b32-f61c-48d7-9845-328403da8b33Product name520250303
81073386-7d67-4d1d-80dd-72b360506a77Product name120200414

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64406-005-01TECFIDERA1 in 1 CARTONCAPSULE155
64406-005-01TECFIDERA14 in 1 BOTTLE, PLASTICCAPSULE1455

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64406-005-01EA - Each64406-005f66b69e7-ec0c-4a86-bd4f-465bc9d06c6012013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
dimethyl fumarateACTIVE INGREDIENTFO2303MNI2TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]32
monomethyl fumarateACTIVE MOIETY45IUB1PX8RTECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]32
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UTECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]32
Croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]32
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OTECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]32
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDTECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]32
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTTECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]32
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]32
GelatinINACTIVE INGREDIENT2G86QN327LTECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]32
Magnesium stearateINACTIVE INGREDIENT70097M6I30TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]32
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type AINACTIVE INGREDIENTNX76LV5T8JTECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]32
Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)INACTIVE INGREDIENT74G4R6TH13TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]32
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HTECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]32
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]32
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JTECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]32
TalcINACTIVE INGREDIENT7SEV7J4R1UTECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]32
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPTECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]32
Triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMTECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64406-005TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]54Current NDC, Legacy NDC, 2 package rows20240319_665d7e74-036c-5f68-5b67-ab84b9b49151.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373498{14 (dimethyl fumarate 120 MG Delayed Release Oral Capsule [Tecfidera]) / 46 (dimethyl fumarate 240 MG Delayed Release Oral Capsule [Tecfidera]) } Pack [Tecfidera 30-Day Starter Pack]BPCK665d7e74-036c-5f68-5b67-ab84b9b4915155
1373497{14 (dimethyl fumarate 120 MG Delayed Release Oral Capsule) / 46 (dimethyl fumarate 240 MG Delayed Release Oral Capsule) } PackGPCK665d7e74-036c-5f68-5b67-ab84b9b4915155
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsulePSN665d7e74-036c-5f68-5b67-ab84b9b4915155
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsulePSN665d7e74-036c-5f68-5b67-ab84b9b4915155
1373497dimethyl fumarate starter dose 120 MG (14), 240 MG (46) Delayed Release Oral Capsule 60 Count PackPSN665d7e74-036c-5f68-5b67-ab84b9b4915155
1373489Tecfidera 120 MG Delayed Release Oral CapsulePSN665d7e74-036c-5f68-5b67-ab84b9b4915155
1373493Tecfidera 240 MG Delayed Release Oral CapsulePSN665d7e74-036c-5f68-5b67-ab84b9b4915155
1373498Tecfidera 30-Day Starter PackPSN665d7e74-036c-5f68-5b67-ab84b9b4915155
1373489dimethyl fumarate 120 MG Delayed Release Oral Capsule [Tecfidera]SBD665d7e74-036c-5f68-5b67-ab84b9b4915155
1373493dimethyl fumarate 240 MG Delayed Release Oral Capsule [Tecfidera]SBD665d7e74-036c-5f68-5b67-ab84b9b4915155
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsuleSCD665d7e74-036c-5f68-5b67-ab84b9b4915155
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsuleSCD665d7e74-036c-5f68-5b67-ab84b9b4915155
1373493Tecfidera (dimethyl fumarate 240 MG) Delayed Release Oral CapsuleSY665d7e74-036c-5f68-5b67-ab84b9b4915155
1373489Tecfidera 120 MG Delayed Release Oral CapsuleSY665d7e74-036c-5f68-5b67-ab84b9b4915155
1373493Tecfidera 240 MG Delayed Release Oral CapsuleSY665d7e74-036c-5f68-5b67-ab84b9b4915155

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64406-005-01644060005011 BOTTLE, PLASTIC in 1 CARTON (64406-005-01) / 14 CAPSULE in 1 BOTTLE, PLASTIC2013-03-270000-00-00NoNoCurrent