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 use Initial U.S. Approval: 2013

Approved

Approval ID

c4003a54-f880-4d06-9b5a-f8043791937b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 31, 2023

Manufacturers

FDA

Accord Healthcare Inc.

DUNS: 604222237

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 Code16729-418

Application NumberANDA210499

Product Classification

Marketing Category

C73584

Generic Name

Dimethyl fumarate

Product Specifications

Effective DateAugust 31, 2023

FDA Product Classification

Dimethyl fumarate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code16729-416

Application NumberANDA210499

Product Classification

Marketing Category

C73584

Generic Name

Dimethyl fumarate

Product Specifications

Route of AdministrationORAL

Effective DateAugust 31, 2023

FDA Product Classification

INGREDIENTS (15)

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

DIMETHYL FUMARATEActive

Quantity: 120 mg in 1 1

Code: FO2303MNI2

Classification: ACTIB

SHELLACInactive

Code: 46N107B71O

Classification: IACT

Dimethyl fumarate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code16729-417

Application NumberANDA210499

Product Classification

Marketing Category

C73584

Generic Name

Dimethyl fumarate

Product Specifications

Route of AdministrationORAL

Effective DateAugust 31, 2023

FDA Product Classification

INGREDIENTS (15)

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

DIMETHYL FUMARATEActive

Quantity: 240 mg in 1 1

Code: FO2303MNI2

Classification: ACTIB

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DIMETHYL FUMARATE

Products 3

Dimethyl fumarate

Product Details

FDA Identifiers

Product Classification

Product Specifications

Dimethyl fumarate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Dimethyl fumarate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

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Company

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