FDA.reportPublic FDA data

dimethyl fumarate

Product NDC
70771-1531
11-digit product format
707711531
Labeler code
70771
Product ID
70771-1531_d8dceb92-b903-4b29-b3e6-4651fbc598fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dimethyl fumarate
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA210538
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
81073386-7d67-4d1d-80dd-72b360506a77Product name120200414

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1531-6dimethyl fumarate60 in 1 BOTTLECAPSULE, DELAYED RELEASE605
70771-1531-8dimethyl fumarate46 in 1 BOTTLECAPSULE, DELAYED RELEASE465

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1531DIMETHYL FUMARATE (DIMETHYL FUMARATE) KIT DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 2 package rows20250403_7203a262-de0f-42dd-b4fb-8856758b82e9.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) } PackGPCK7203a262-de0f-42dd-b4fb-8856758b82e95
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsulePSN7203a262-de0f-42dd-b4fb-8856758b82e95
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsulePSN7203a262-de0f-42dd-b4fb-8856758b82e95
1373497dimethyl fumarate starter dose 120 MG (14), 240 MG (46) Delayed Release Oral Capsule 60 Count PackPSN7203a262-de0f-42dd-b4fb-8856758b82e95
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsuleSCD7203a262-de0f-42dd-b4fb-8856758b82e95
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsuleSCD7203a262-de0f-42dd-b4fb-8856758b82e95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70771-1531-67077115310660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70771-1531-6) 2020-09-280000-00-00YesNoCurrent
70771-1531-87077115310846 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70771-1531-8) 2020-09-280000-00-00YesNoCurrent