FDA.reportPublic FDA data

Dimethyl Fumarate

Product NDC
33342-349
11-digit product format
333420349
Labeler code
33342
Product ID
33342-349_ef3e9cf5-b172-4e67-b621-dc94e9e9d93f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dimethyl Fumarate
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA210377
Marketing category
ANDA
Marketing start
2024-06-26
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
Dimethyl Fumarate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHYL FUMARATE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFO2303MNI2
Rxcui1373483, 1373491, 1373497

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
33342-349-09Dimethyl Fumarate60 in 1 BOTTLECAPSULE, DELAYED RELEASE602
33342-349-91Dimethyl Fumarate14 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE14120 mg2
33342-349-94Dimethyl Fumarate14 in 1 BOTTLECAPSULE, DELAYED RELEASE14120 mg2
33342-349-94Dimethyl Fumarate14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
33342-349-97Dimethyl Fumarate14 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE142
33342-349-97Dimethyl Fumarate1 in 1 CARTONCAPSULE, DELAYED RELEASE12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-349-94EA - Each33342-349615d1b2e-47e1-4109-ba89-a502a5fdf49c12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-349DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE DIMETHYL FUMARATE KIT [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, 4 package rows20240716_f8ada3e3-55c0-43e3-95b9-c6d11ffc42dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373497{14 (dimethyl fumarate 120 MG Delayed Release Oral Capsule) / 46 (dimethyl fumarate 240 MG Delayed Release Oral Capsule) } PackGPCKf8ada3e3-55c0-43e3-95b9-c6d11ffc42dd2
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsulePSNf8ada3e3-55c0-43e3-95b9-c6d11ffc42dd2
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsulePSNf8ada3e3-55c0-43e3-95b9-c6d11ffc42dd2
1373497dimethyl fumarate starter dose 120 MG (14), 240 MG (46) Delayed Release Oral Capsule 60 Count PackPSNf8ada3e3-55c0-43e3-95b9-c6d11ffc42dd2
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsuleSCDf8ada3e3-55c0-43e3-95b9-c6d11ffc42dd2
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsuleSCDf8ada3e3-55c0-43e3-95b9-c6d11ffc42dd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-349-093334203490960 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-349-09) 2024-06-26NoNoCurrent
33342-349-913334203499114 in 1 BLISTER PACKHistorical
33342-349-943334203499414 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-349-94) 2025-06-27NoNoCurrent
33342-349-97333420349971 BLISTER PACK in 1 CARTON (33342-349-97) / 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2024-06-26NoNoCurrent