Label: DIMETHYL FUMARATE- dimethyl fumarate kit
DIMETHYL FUMARATE capsule, delayed release

  • NDC Code(s): 70771-1530-7, 70771-1531-6, 70771-1531-8, 70771-1532-3
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 23, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1532-3

    30-Day Starter Pack Carton Label

    Dimethyl Fumarate Delayed-release Capsules

    120 mg Starter Dose: 14 Capsules

    240 mg Regular Dose: 46 Capsules

    Rx only

    label

    NDC 70771-1530-7

    Dimethyl Fumarate Delayed-release Capsules, 120 mg

    14 Capsules

    Rx only

    label

    NDC 70771-1531-6

    Dimethyl Fumarate Delayed-release Capsules, 240 mg

    60 Capsules

    Rx only

    label
  • INGREDIENTS AND APPEARANCE
    DIMETHYL FUMARATE  
    dimethyl fumarate kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1532
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1532-31 in 1 KIT; Type 0: Not a Combination Product09/28/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 14 
    Part 21 BOTTLE 46 
    Part 1 of 2
    DIMETHYL FUMARATE  
    dimethyl fumarate capsule, delayed release
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHYL FUMARATE (UNII: FO2303MNI2) (MONOMETHYL FUMARATE - UNII:45IUB1PX8R) DIMETHYL FUMARATE120 mg
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERYL MONO AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorGREEN (OPAQUE LIGHT GREEN CAP) , WHITE (OPAQUE WHITE BODY) Scoreno score
    ShapeCAPSULE (CAPSULE) Size22mm
    FlavorImprint Code 1204
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21053809/28/2020
    Part 2 of 2
    DIMETHYL FUMARATE  
    dimethyl fumarate capsule, delayed release
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHYL FUMARATE (UNII: FO2303MNI2) (MONOMETHYL FUMARATE - UNII:45IUB1PX8R) DIMETHYL FUMARATE240 mg
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERYL MONO AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorGREEN (OPAQUE LIGHT GREEN CAP) , GREEN (OPAQUE LIGHT GREEN BODY) Scoreno score
    ShapeCAPSULE (CAPSULE) Size22mm
    FlavorImprint Code 1205
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    146 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21053809/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21053809/28/2020
    DIMETHYL FUMARATE 
    dimethyl fumarate capsule, delayed release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1530
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHYL FUMARATE (UNII: FO2303MNI2) (MONOMETHYL FUMARATE - UNII:45IUB1PX8R) DIMETHYL FUMARATE120 mg
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorGREEN (OPAQUE LIGHT GREEN CAP) , WHITE (OPAQUE WHITE BODY) Scoreno score
    ShapeCAPSULE (CAPSULE) Size22mm
    FlavorImprint Code 1204
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1530-714 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21053809/28/2020
    DIMETHYL FUMARATE 
    dimethyl fumarate capsule, delayed release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1531
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHYL FUMARATE (UNII: FO2303MNI2) (MONOMETHYL FUMARATE - UNII:45IUB1PX8R) DIMETHYL FUMARATE240 mg
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorGREEN (OPAQUE LIGHT GREEN CAP) , GREEN (OPAQUE LIGHT GREEN BODY) Scoreno score
    ShapeCAPSULE (CAPSULE) Size22mm
    FlavorImprint Code 1205
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1531-846 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2020
    2NDC:70771-1531-660 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21053809/28/2020
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (863362789)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1530, 70771-1531, 70771-1532) , MANUFACTURE(70771-1530, 70771-1531, 70771-1532)