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
354a97e8-35c8-418b-91b2-9e8e066cec65
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2024
Manufacturers
FDA
Accord Healthcare Inc.
DUNS: 604222237
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 Code16729-292
Application NumberANDA206863
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dalfampridine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2024
FDA Product Classification
INGREDIENTS (8)
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
DALFAMPRIDINEActive
Quantity: 10 mg in 1 1
Code: BH3B64OKL9
Classification: ACTIB