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"70518-3546-0" National Drug Code (NDC)

Sirolimus 100 POUCH in 1 BOX (70518-3546-0) / 1 TABLET in 1 POUCH (70518-3546-1)
(REMEDYREPACK INC.)

NDC Code70518-3546-0
Package Description100 POUCH in 1 BOX (70518-3546-0) / 1 TABLET in 1 POUCH (70518-3546-1)
Product NDC70518-3546
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSirolimus
Non-Proprietary NameSirolimus
Dosage FormTABLET
UsageORAL
Start Marketing Date20220930
Marketing Category NameANDA
Application NumberANDA214753
ManufacturerREMEDYREPACK INC.
Substance NameSIROLIMUS
Strength.5
Strength Unitmg/1
Pharmacy ClassesDecreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]

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