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NDC 16729-0418-12 DIMETHYL FUMARATE Details

DIMETHYL FUMARATE

DIMETHYL FUMARATE is a KIT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Accord Healthcare Inc.. The primary component is .

MedlinePlus Drug Summary

Dimethyl fumarate is used to treat adults with relapsing forms of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control) including clinically isolated syndrome (CIS; nerve symptom episodes that last at least 24 hours), relapsing-remitting forms (course of disease where symptoms flare up from time to time), or secondary progressive forms (course of disease where relapses occur more often). Dimethyl fumarate is in a class of medications called Nrf2 activators. It works by decreasing inflammation and preventing nerve damage that may cause symptoms of multiple sclerosis.

Related Packages: 16729-0418-12
Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Dimethyl Fumarate

Product Information

NDC	16729-0418
Product ID	16729-418_0436f7b5-1dd6-37bf-e063-6394a90a963b
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	DIMETHYL FUMARATE
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dimethyl fumarate
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	Accord Healthcare Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA210499
Listing Certified Through	2024-12-31

Package

NDC 16729-0418-12 (16729041812)

Pricing Information	N/A
NDC Package Code	16729-418-12
Billing NDC	16729041812
Package	1 KIT in 1 KIT (16729-418-12) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16729-416-54) * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16729-417-46)
Marketing Start Date	2022-09-26
NDC Exclude Flag	N