DIMETHYL FUMARATE - dimethyl fumarate 
DIMETHYL FUMARATE- dimethyl fumarate capsule, delayed release 
Zydus Lifesciences Limited

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DIMETHYL FUMARATE DELAYED-RELEASE CAPSULES

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
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 - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
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 - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
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 - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (863362789)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1530, 70771-1531, 70771-1532) , MANUFACTURE(70771-1530, 70771-1531, 70771-1532)

Revised: 10/2022
Document Id: 71df19ca-2bf4-489c-a411-ee237d511b8b
Set id: 7203a262-de0f-42dd-b4fb-8856758b82e9
Version: 2
Effective Time: 20221013
 
Zydus Lifesciences Limited