"53002-0550-3" National Drug Code (NDC)

Terbinafine 30 TABLET in 1 BOTTLE (53002-0550-3)
(RPK Pharmaceuticals, Inc.)

NDC Code53002-0550-3
Package Description30 TABLET in 1 BOTTLE (53002-0550-3)
Product NDC53002-0550
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTerbinafine
Non-Proprietary NameTerbinafine Hydrochloride
Dosage FormTABLET
UsageORAL
Start Marketing Date20070702
Marketing Category NameANDA
Application NumberANDA078297
ManufacturerRPK Pharmaceuticals, Inc.
Substance NameTERBINAFINE HYDROCHLORIDE
Strength250
Strength Unitmg/1
Pharmacy ClassesAllylamine Antifungal [EPC], Allylamine [CS]

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