FDA.reportPublic FDA data

Dimethyl fumarate

Product NDC
67877-556
11-digit product format
678770556
Labeler code
67877
Product ID
67877-556_75f80267-a5b2-4117-8003-05da3e461217
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dimethyl fumarate
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA210440
Marketing category
ANDA
Marketing start
2020-09-26
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
81073386-7d67-4d1d-80dd-72b360506a77Product name120200414

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-556-10Dimethyl fumarate1000 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE100016
67877-556-33Dimethyl fumarate10 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1016
67877-556-46Dimethyl fumarate46 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE4616
67877-556-60Dimethyl fumarate60 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE6016
67877-556-90Dimethyl fumarate90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE9016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-556DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE DIMETHYL FUMARATE KIT [ASCEND LABORATORIES, LLC]15Current NDC, Legacy NDC, 5 package rows20240730_e12d8fee-bd18-4f84-8333-c890f1d132b7.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) } PackGPCKe12d8fee-bd18-4f84-8333-c890f1d132b716
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsulePSNe12d8fee-bd18-4f84-8333-c890f1d132b716
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsulePSNe12d8fee-bd18-4f84-8333-c890f1d132b716
1373497dimethyl fumarate starter dose 120 MG (14), 240 MG (46) Delayed Release Oral Capsule 60 Count PackPSNe12d8fee-bd18-4f84-8333-c890f1d132b716
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsuleSCDe12d8fee-bd18-4f84-8333-c890f1d132b716
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsuleSCDe12d8fee-bd18-4f84-8333-c890f1d132b716

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-556-10678770556101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67877-556-10) 2020-09-260000-00-00NoNoCurrent
67877-556-336787705563310 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67877-556-33) 2020-09-260000-00-00NoNoCurrent
67877-556-466787705564646 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67877-556-46) 2020-09-260000-00-00NoNoCurrent
67877-556-606787705566060 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67877-556-60) 2020-09-260000-00-00NoNoCurrent
67877-556-906787705569090 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67877-556-90) 2020-09-260000-00-00NoNoCurrent