"69238-1594-3" National Drug Code (NDC)

Sirolimus 1 CARTON in 1 KIT (69238-1594-3) / 1 BOTTLE, GLASS in 1 CARTON (69238-1594-6) / 60 mL in 1 BOTTLE, GLASS
(Amneal Pharmaceuticals NY LLC)

NDC Code69238-1594-3
Package Description1 CARTON in 1 KIT (69238-1594-3) / 1 BOTTLE, GLASS in 1 CARTON (69238-1594-6) / 60 mL in 1 BOTTLE, GLASS
Product NDC69238-1594
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSirolimus
Non-Proprietary NameSirolimus
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20191025
Marketing Category NameANDA
Application NumberANDA211212
ManufacturerAmneal Pharmaceuticals NY LLC
Substance NameSIROLIMUS
Strength1
Strength Unitmg/mL
Pharmacy ClassesDecreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]

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