"70518-3795-0" National Drug Code (NDC)

Sirolimus 100 POUCH in 1 BOX (70518-3795-0) / 1 TABLET in 1 POUCH (70518-3795-1)
(REMEDYREPACK INC.)

NDC Code70518-3795-0
Package Description100 POUCH in 1 BOX (70518-3795-0) / 1 TABLET in 1 POUCH (70518-3795-1)
Product NDC70518-3795
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSirolimus
Non-Proprietary NameSirolimus
Dosage FormTABLET
UsageORAL
Start Marketing Date20230717
Marketing Category NameANDA
Application NumberANDA201578
ManufacturerREMEDYREPACK INC.
Substance NameSIROLIMUS
Strength1
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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