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
e7ef9b9e-d97a-4a56-b792-a1a255613156
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 9, 2022
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
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 Code70710-1205
Application NumberANDA210538
Product Classification
M
Marketing Category
C73584
G
Generic Name
dimethyl fumarate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2022
FDA Product Classification
INGREDIENTS (25)
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDESInactive
Code: U72Q2I8C85
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
DIMETHYL FUMARATEActive
Quantity: 240 mg in 1 1
Code: FO2303MNI2
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
dimethyl fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1204
Application NumberANDA210538
Product Classification
M
Marketing Category
C73584
G
Generic Name
dimethyl fumarate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2022
FDA Product Classification
INGREDIENTS (25)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDESInactive
Code: U72Q2I8C85
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
DIMETHYL FUMARATEActive
Quantity: 120 mg in 1 1
Code: FO2303MNI2
Classification: ACTIB
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
dimethyl fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1416
Application NumberANDA210538
Product Classification
M
Marketing Category
C73584
G
Generic Name
dimethyl fumarate
Product Specifications
Effective DateNovember 9, 2022
FDA Product Classification