FDA.reportPublic FDA data

dimethyl fumarate

Product NDC
24979-127
11-digit product format
249790127
Labeler code
24979
Product ID
24979-127_8b1210a2-c1ad-44b7-8afe-a5c55bfb5be8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dimethyl fumarate
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA210382
Marketing category
ANDA
Marketing start
2020-12-01
Substance
DIMETHYL FUMARATE
Active strength
120 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
dimethyl fumarate
Listing expiration
2027-12-31

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
81073386-7d67-4d1d-80dd-72b360506a77Product name120200414

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24979-127-02dimethyl fumarate500 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE50010
24979-127-21dimethyl fumarate14 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE1410

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24979-127-21EA - Each24979-1276aca4675-0bd2-4ad4-84fd-abac594d02bd12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24979-127DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE [UPSHER-SMITH LABORATORIES, LLC]8Current NDC, Legacy NDC, 2 package rows20241206_48f56f42-2247-41a9-a1e9-07c3af50e549.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsulePSN48f56f42-2247-41a9-a1e9-07c3af50e54910
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsulePSN48f56f42-2247-41a9-a1e9-07c3af50e54910
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsuleSCD48f56f42-2247-41a9-a1e9-07c3af50e54910
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsuleSCD48f56f42-2247-41a9-a1e9-07c3af50e54910
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsulePSNb8e5184d-5d1d-0a89-e053-2995a90a2d6d9
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsulePSNb8e5184d-5d1d-0a89-e053-2995a90a2d6d9
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsuleSCDb8e5184d-5d1d-0a89-e053-2995a90a2d6d9
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsuleSCDb8e5184d-5d1d-0a89-e053-2995a90a2d6d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24979-127-0224979012702500 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (24979-127-02) 2020-12-010000-00-00NoNoCurrent
24979-127-212497901272114 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (24979-127-21) 2020-12-010000-00-00NoNoCurrent