FDA.reportPublic FDA data

Dimethyl fumarate

Product NDC
82249-745
11-digit product format
822490745
Labeler code
82249
Product ID
82249-745_ca6c6bda-05ac-4a39-8356-86bdfa61e863
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dimethyl fumarate
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
CivicaScript LLC
Application
ANDA210440
Marketing category
ANDA
Marketing start
2025-06-11
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

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
82249-745-14Dimethyl fumarate14 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE142

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsulePSNf3002b6a-841e-4247-9155-3acfb30cabcd2
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsulePSNf3002b6a-841e-4247-9155-3acfb30cabcd2
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsuleSCDf3002b6a-841e-4247-9155-3acfb30cabcd2
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsuleSCDf3002b6a-841e-4247-9155-3acfb30cabcd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82249-745-148224907451414 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (82249-745-14) 2025-06-11NoNoCurrent