"0378-4504-05" National Drug Code (NDC)

Dalfampridine 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4504-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-4504-05
Package Description500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4504-05)
Product NDC0378-4504
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDalfampridine
Non-Proprietary NameDalfampridine
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20220531
Marketing Category NameANDA
Application NumberANDA206858
ManufacturerMylan Pharmaceuticals Inc.
Substance NameDALFAMPRIDINE
Strength10
Strength Unitmg/1
Pharmacy ClassesPotassium Channel Antagonists [MoA], Potassium Channel Blocker [EPC]

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