FDA.reportPublic FDA data

DIMETHYL FUMARATE

Product NDC
68462-307
11-digit product format
684620307
Labeler code
68462
Product ID
68462-307_74611591-657b-40e8-8ae1-1e5533a05d97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dimethyl-fumarate
Dosage form
CAPSULE
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA210309
Marketing category
ANDA
Marketing start
2020-10-06
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, 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
68462-307-05DIMETHYL FUMARATE500 in 1 BOTTLECAPSULE5007
68462-307-41DIMETHYL FUMARATE14 in 1 BOTTLECAPSULE147

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-307DIMETHYL FUMARATE (DIMETHYL FUMARATE KIT) KIT DIMETHYL FUMARATE (DIMETHYL-FUMARATE) CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7Current NDC, Legacy NDC, 2 package rows20240427_c3f65da9-f5f4-4161-aded-c23b16fd49ed.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) } PackGPCKc3f65da9-f5f4-4161-aded-c23b16fd49ed7
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsulePSNc3f65da9-f5f4-4161-aded-c23b16fd49ed7
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsulePSNc3f65da9-f5f4-4161-aded-c23b16fd49ed7
1373497dimethyl fumarate starter dose 120 MG (14), 240 MG (46) Delayed Release Oral Capsule 60 Count PackPSNc3f65da9-f5f4-4161-aded-c23b16fd49ed7
1373483dimethyl fumarate 120 MG Delayed Release Oral CapsuleSCDc3f65da9-f5f4-4161-aded-c23b16fd49ed7
1373491dimethyl fumarate 240 MG Delayed Release Oral CapsuleSCDc3f65da9-f5f4-4161-aded-c23b16fd49ed7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-307-0568462030705500 CAPSULE in 1 BOTTLE (68462-307-05) 500 capsule2020-10-060000-00-00NoNoCurrent
68462-307-416846203074114 CAPSULE in 1 BOTTLE (68462-307-41) 14 capsule2020-10-060000-00-00NoNoCurrent