Dimethyl Fumarate (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70710-1416-3

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

Zydus

label
(click image for full-size original)

NDC 70710-1204-7

Dimethyl Fumarate Delayed-release Capsules, 120 mg

14 Capsules

Rx only

Zydus

label
(click image for full-size original)

NDC 70710-1205-6

Dimethyl Fumarate Delayed-release Capsules, 240 mg

60 Capsules

Rx only

Zydus

label
(click image for full-size original)
DIMETHYL FUMARATE dimethyl fumarate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1416
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70710-1416-3 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 14
Part 2 1 BOTTLE 46
Part 1 of 2
DIMETHYL FUMARATE dimethyl fumarate capsule, delayed release
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHYL FUMARATE (MONOMETHYL FUMARATE) DIMETHYL FUMARATE 120 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GELATIN
GLYCERYL MONO AND DICAPRYLOCAPRATE
MAGNESIUM STEARATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
POLYSORBATE 80
POTASSIUM HYDROXIDE
POVIDONE K30
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color GREEN (OPAQUE LIGHT GREEN CAP) , WHITE (OPAQUE WHITE BODY) Score no score
Shape CAPSULE (CAPSULE) Size 22mm
Flavor Imprint Code 1204
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210538 09/28/2020
Part 2 of 2
DIMETHYL FUMARATE dimethyl fumarate capsule, delayed release
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHYL FUMARATE (MONOMETHYL FUMARATE) DIMETHYL FUMARATE 240 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GELATIN
GLYCERYL MONO AND DICAPRYLOCAPRATE
MAGNESIUM STEARATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
POLYSORBATE 80
POTASSIUM HYDROXIDE
POVIDONE K30
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color GREEN (OPAQUE LIGHT GREEN CAP) , GREEN (OPAQUE LIGHT GREEN BODY) Score no score
Shape CAPSULE (CAPSULE) Size 22mm
Flavor Imprint Code 1205
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210538 09/28/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210538 09/28/2020
DIMETHYL FUMARATE dimethyl fumarate capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1204
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHYL FUMARATE (MONOMETHYL FUMARATE) DIMETHYL FUMARATE 120 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GELATIN
MAGNESIUM STEARATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
POLYSORBATE 80
POTASSIUM HYDROXIDE
POVIDONE K30
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color GREEN (OPAQUE LIGHT GREEN CAP) , WHITE (OPAQUE WHITE BODY) Score no score
Shape CAPSULE (CAPSULE) Size 22mm
Flavor Imprint Code 1204
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70710-1204-7 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210538 09/28/2020
DIMETHYL FUMARATE dimethyl fumarate capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1205
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHYL FUMARATE (MONOMETHYL FUMARATE) DIMETHYL FUMARATE 240 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GELATIN
MAGNESIUM STEARATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
POLYSORBATE 80
POTASSIUM HYDROXIDE
POVIDONE K30
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color GREEN (OPAQUE LIGHT GREEN CAP) , GREEN (OPAQUE LIGHT GREEN BODY) Score no score
Shape CAPSULE (CAPSULE) Size 22mm
Flavor Imprint Code 1205
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70710-1205-8 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:70710-1205-6 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210538 09/28/2020
Labeler — Zydus Pharmaceuticals USA Inc. (156861945)
Registrant — Zydus Pharmaceuticals USA Inc. (156861945)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 863362789 ANALYSIS (70710-1204), ANALYSIS (70710-1205), ANALYSIS (70710-1416), MANUFACTURE (70710-1204), MANUFACTURE (70710-1205), MANUFACTURE (70710-1416)

Revised: 11/2022 Zydus Pharmaceuticals USA Inc.

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