"60505-4833-2" National Drug Code (NDC)

Fidaxomicin 1 BOTTLE in 1 CARTON (60505-4833-2) / 20 TABLET, FILM COATED in 1 BOTTLE
(Apotex Corp.)

NDC Code60505-4833-2
Package Description1 BOTTLE in 1 CARTON (60505-4833-2) / 20 TABLET, FILM COATED in 1 BOTTLE
Product NDC60505-4833
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameFidaxomicin
Non-Proprietary NameFidaxomicin
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20260203
Marketing Category NameANDA
Application NumberANDA219559
ManufacturerApotex Corp.
Substance NameFIDAXOMICIN
Strength200
Strength Unitmg/1
Pharmacy ClassesMacrolide Antibacterial [EPC], Macrolides [CS]

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