FDA.reportPublic FDA data

Dimethyl Fumarate

Product NDC
69238-1318
11-digit product format
692381318
Labeler code
69238
Product ID
69238-1318_76c5e6b0-c799-45cf-adb6-2d3845639b62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dimethyl Fumarate
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA210402
Marketing category
ANDA
Marketing start
2020-09-28
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
69238-1318-4Dimethyl Fumarate14 in 1 BOTTLECAPSULE, DELAYED RELEASE1414
69238-1318-4Dimethyl Fumarate1 in 1 CARTONCAPSULE, DELAYED RELEASE114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1318DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE DIMETHYL FUMARATE KIT [AMNEAL PHARMACEUTICALS NY LLC]13Current NDC, Legacy NDC, 2 package rows20240629_4c7626c6-2b1b-4865-818c-0c79c18c049d.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) } PackGPCK4c7626c6-2b1b-4865-818c-0c79c18c049d14
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsulePSN4c7626c6-2b1b-4865-818c-0c79c18c049d14
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsulePSN4c7626c6-2b1b-4865-818c-0c79c18c049d14
1373497dimethyl fumarate starter dose 120 MG (14), 240 MG (46) Delayed Release Oral Capsule 60 Count PackPSN4c7626c6-2b1b-4865-818c-0c79c18c049d14
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsuleSCD4c7626c6-2b1b-4865-818c-0c79c18c049d14
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsuleSCD4c7626c6-2b1b-4865-818c-0c79c18c049d14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1318-4692381318041 BOTTLE in 1 CARTON (69238-1318-4) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2020-09-280000-00-00NoNoCurrent