Dimethyl Fumarate (Page 6 of 6)

DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE DIMETHYL FUMARATE KIT

Label ImageLabel Image
DIMETHYL FUMARATE dimethyl fumarate capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-5288(NDC:31722-658)
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
CALCIUM SILICATE
CROSCARMELLOSE SODIUM
GELATIN, UNSPECIFIED
MAGNESIUM STEARATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
POLYSORBATE 80
SODIUM BICARBONATE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
MICROCRYSTALLINE CELLULOSE
AMMONIA
POLOXAMER 407
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
Product Characteristics
Color WHITE (white opaque) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code H;D15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-5288-0 1 CAPSULE, DELAYED RELEASE in 1 KIT None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210500 09/24/2020
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-5288)

Revised: 10/2020 A-S Medication Solutions

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