NDC 0378-0396 Dimethyl Fumarate
Capsule, Delayed Release Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
WHITE (C48325 - WHITE OPAQUE)
Code Structure Chart
Product Details
What is NDC 0378-0396?
What are the uses for Dimethyl Fumarate?
What are Dimethyl Fumarate Active Ingredients?
- DIMETHYL FUMARATE 120 mg/1 - A fumarate derivative that is used as a DERMATOLOGIC AGENT in the treatment of PSORIASIS and SKIN DISEASES. It also may be used as an IMMUNOSUPPRESSIVE AGENT in the treatment of MULTIPLE SCLEROSIS.
Which are Dimethyl Fumarate UNII Codes?
The UNII codes for the active ingredients in this product are:
- DIMETHYL FUMARATE (UNII: FO2303MNI2)
- MONOMETHYL FUMARATE (UNII: 45IUB1PX8R) (Active Moiety)
Which are Dimethyl Fumarate Inactive Ingredients UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- AMMONIA (UNII: 5138Q19F1X)
- FERROSOFERRIC OXIDE (UNII: XM0M87F357)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
- GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
- METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
- POLYSORBATE 80 (UNII: 6OZP39ZG8H)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- SHELLAC (UNII: 46N107B71O)
- SODIUM LAURYL SULFATE (UNII: 368GB5141J)
- TALC (UNII: 7SEV7J4R1U)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
- FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
What is the NDC to RxNorm Crosswalk for Dimethyl Fumarate?
- RxCUI: 1373483 - dimethyl fumarate 120 MG Delayed Release Oral Capsule
- RxCUI: 1373491 - dimethyl fumarate 240 MG Delayed Release Oral Capsule
* Please review the disclaimer below.
Patient Education
Dimethyl Fumarate
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.
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* Please review the disclaimer below.
[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.
[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".