Dalfampridine
These highlights do not include all the information needed to use DALFAMPRIDINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DALFAMPRIDINE EXTENDED-RELEASE TABLETS. DALFAMPRIDINE extended-release tablets, for oral use Initial U.S. Approval: 2010
Approved
Approval ID
b9ad68e2-a515-4dba-915d-401c555a8a26
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 16, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dalfampridine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-9450
Application NumberANDA206765
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dalfampridine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 18, 2021
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DALFAMPRIDINEActive
Quantity: 10 mg in 1 1
Code: BH3B64OKL9
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT