BAFIERTAM
These highlights do not include all the information needed to use BAFIERTAM safely and effectively. See full prescribing information for BAFIERTAM. BAFIERTAM (monomethyl fumarate) delayed-release capsules, for oral use Initial U.S. Approval: 2013
Approved
Approval ID
a161f9d4-70f1-4097-957a-eafb35d3274f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
Banner Life Sciences LLC
DUNS: 079579273
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
monomethyl fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69387-001
Application NumberNDA210296
Product Classification
M
Marketing Category
C73594
G
Generic Name
monomethyl fumarate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2023
FDA Product Classification
INGREDIENTS (22)
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type AInactive
Code: NX76LV5T8J
Classification: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UM
Classification: IACT
monomethyl fumarateActive
Quantity: 95 mg in 1 1
Code: 45IUB1PX8R
Classification: ACTIB
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
Hypromellose 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT
Polyvinyl Alcohol, UnspecifiedInactive
Code: 532B59J990
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
Glyceryl MonocaprylocaprateInactive
Code: G7515SW10N
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
SorbitanInactive
Code: 6O92ICV9RU
Classification: IACT
SorbitolInactive
Code: 506T60A25R
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
Isopropyl AlcoholInactive
Code: ND2M416302
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
Butyl AlcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
Propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
Lactic Acid, Unspecified FormInactive
Code: 33X04XA5AT
Classification: IACT
gelatin, unspecifiedInactive
Code: 2G86QN327L
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Glyceryl CaprylocaprateInactive
Code: U72Q2I8C85
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT