FDA.reportPublic FDA data

Dimethyl Fumarate

Product NDC
69539-043
11-digit product format
695390043
Labeler code
69539
Product ID
69539-043_1e7672d0-2532-401b-81a2-dd76968d2745
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dimethyl fumarate
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
MSN LABORATORIES PRIVATE LIMITED
Application
ANDA210460
Marketing category
ANDA
Marketing start
2020-09-28
Substance
DIMETHYL FUMARATE
Active strength
240 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 FUMARATE240 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
81073386-7d67-4d1d-80dd-72b360506a77Product name120200414

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69539-043-05Dimethyl Fumarate1 in 1 CARTONCAPSULE, DELAYED RELEASE16
69539-043-05Dimethyl Fumarate500 in 1 BOTTLECAPSULE, DELAYED RELEASE5006
69539-043-60Dimethyl Fumarate1 in 1 CARTONCAPSULE, DELAYED RELEASE16
69539-043-60Dimethyl Fumarate60 in 1 BOTTLECAPSULE, DELAYED RELEASE606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69539-043DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE DIMETHYL FUMARATE KIT [MSN LABORATORIES PRIVATE LIMITED]6Current NDC, Legacy NDC, 4 package rows20210714_074d2820-6cb4-437a-8f6f-a21cb0a8ee02.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) } PackGPCK074d2820-6cb4-437a-8f6f-a21cb0a8ee026
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsulePSN074d2820-6cb4-437a-8f6f-a21cb0a8ee026
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsulePSN074d2820-6cb4-437a-8f6f-a21cb0a8ee026
1373497dimethyl fumarate starter dose 120 MG (14), 240 MG (46) Delayed Release Oral Capsule 60 Count PackPSN074d2820-6cb4-437a-8f6f-a21cb0a8ee026
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsuleSCD074d2820-6cb4-437a-8f6f-a21cb0a8ee026
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsuleSCD074d2820-6cb4-437a-8f6f-a21cb0a8ee026

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69539-043-05695390043051 BOTTLE in 1 CARTON (69539-043-05) / 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2020-09-280000-00-00NoNoCurrent
69539-043-60695390043601 BOTTLE in 1 CARTON (69539-043-60) / 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2020-09-280000-00-00NoNoCurrent