NDC 0378-0396

Dimethyl fumarate

Dimethyl Fumarate

Dimethyl fumarate is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Dimethyl Fumarate.

Product ID0378-0396_1888a317-0865-475a-988d-f15f63b5756e
NDC0378-0396
Product TypeHuman Prescription Drug
Proprietary NameDimethyl fumarate
Generic NameDimethyl Fumarate
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2020-08-18
Marketing CategoryANDA / ANDA
Application NumberANDA210531
Labeler NameMylan Pharmaceuticals Inc.
Substance NameDIMETHYL FUMARATE
Active Ingredient Strength120 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0378-0396-14

14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-0396-14)
Marketing Start Date2020-08-18
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Dimethyl fumarate" or generic name "Dimethyl Fumarate"

NDCBrand NameGeneric Name
0093-9218dimethyl fumaratedimethyl fumarate
0093-9219dimethyl fumaratedimethyl fumarate
0378-0396Dimethyl fumarateDimethyl fumarate
0378-0399Dimethyl fumarateDimethyl fumarate
16729-416DIMETHYL FUMARATEDIMETHYL FUMARATE
16729-417DIMETHYL FUMARATEDIMETHYL FUMARATE
16729-418DIMETHYL FUMARATEDIMETHYL FUMARATE
24979-127dimethyl fumaratedimethyl fumarate
24979-128dimethyl fumaratedimethyl fumarate
24979-129dimethyl fumaratedimethyl fumarate
31722-657Dimethyl FumarateDimethyl Fumarate
31722-658Dimethyl FumarateDimethyl Fumarate
31722-680Dimethyl FumarateDimethyl Fumarate
43547-024DIMETHYL FUMARATEdimethyl fumarate
43547-025DIMETHYL FUMARATEdimethyl fumarate
43598-429Dimethyl FumarateDimethyl fumarate
43598-430Dimethyl FumarateDimethyl fumarate
50090-5288Dimethyl FumarateDimethyl Fumarate
51407-441dimethyl fumaratedimethyl fumarate
67877-555Dimethyl fumarateDimethyl fumarate
68180-777DIMETHYL FUMARATEDIMETHYL FUMARATE
69097-322DIMETHYL FUMARATEDIMETHYL FUMARATE
70710-1205dimethyl fumaratedimethyl fumarate
67877-556Dimethyl fumarateDimethyl fumarate
68462-308DIMETHYL FUMARATEDIMETHYL FUMARATE
70771-1531dimethyl fumaratedimethyl fumarate
69097-323DIMETHYL FUMARATEDIMETHYL FUMARATE
69097-552DIMETHYL FUMARATEDIMETHYL FUMARATE
70710-1204dimethyl fumaratedimethyl fumarate
70771-1530dimethyl fumaratedimethyl fumarate
69238-1319Dimethyl FumarateDimethyl Fumarate
69238-1626DIMETHYL FUMARATEDIMETHYL FUMARATE
68180-776DIMETHYL FUMARATEDIMETHYL FUMARATE
70710-1416dimethyl fumaratedimethyl fumarate
67877-557Dimethyl FumarateDimethyl Fumarate
68462-307DIMETHYL FUMARATEDIMETHYL FUMARATE
68462-570DIMETHYL FUMARATEDIMETHYL FUMARATE
69238-1318Dimethyl FumarateDimethyl Fumarate
69539-043Dimethyl FumarateDimethyl Fumarate
68180-778DIMETHYL FUMARATEDIMETHYL FUMARATE
69539-042Dimethyl FumarateDimethyl Fumarate
70771-1532dimethyl fumaratedimethyl fumarate

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