"70518-4421-1" National Drug Code (NDC)

Terbinafine 45 TABLET in 1 BOTTLE, PLASTIC (70518-4421-1)
(REMEDYREPACK INC.)

NDC Code70518-4421-1
Package Description45 TABLET in 1 BOTTLE, PLASTIC (70518-4421-1)
Product NDC70518-4421
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTerbinafine
Non-Proprietary NameTerbinafine
Dosage FormTABLET
UsageORAL
Start Marketing Date20250804
Marketing Category NameANDA
Application NumberANDA077533
ManufacturerREMEDYREPACK INC.
Substance NameTERBINAFINE HYDROCHLORIDE
Strength250
Strength Unitmg/1
Pharmacy ClassesAllylamine Antifungal [EPC], Allylamine [CS]

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