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
d61e15fa-0334-49a0-ab41-c9a36b726b57
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 16, 2023
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
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 Code62756-429
Application NumberANDA208292
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dalfampridine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 16, 2023
FDA Product Classification
INGREDIENTS (14)
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
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
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT