DIMETHYL FUMARATE
These highlights do not include all the information needed to use DIMETHYL FUMARATE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DIMETHYL FUMARATE DELAYED-RELEASE CAPSULES. DIMETHYL FUMARATE delayed-release capsules, for oral useInitial U.S. Approval: 2013
Approved
Approval ID
c3f65da9-f5f4-4161-aded-c23b16fd49ed
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2024
Manufacturers
FDA
Glenmark Pharmaceuticals Inc., USA
DUNS: 130597813
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dimethyl-fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-308
Application NumberANDA210309
Product Classification
M
Marketing Category
C73584
G
Generic Name
dimethyl-fumarate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2024
FDA Product Classification
INGREDIENTS (20)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
DIMETHYL FUMARATEActive
Quantity: 240 mg in 1 1
Code: FO2303MNI2
Classification: ACTIB
dimethyl-fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-307
Application NumberANDA210309
Product Classification
M
Marketing Category
C73584
G
Generic Name
dimethyl-fumarate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2024
FDA Product Classification
INGREDIENTS (20)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIMETHYL FUMARATEActive
Quantity: 120 mg in 1 1
Code: FO2303MNI2
Classification: ACTIB
dimethyl fumarate kit
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-570
Application NumberANDA210309
Product Classification
M
Marketing Category
C73584
G
Generic Name
dimethyl fumarate kit
Product Specifications
Effective DateJanuary 12, 2024
FDA Product Classification