"68382-520-05" National Drug Code (NDC)

Sirolimus 500 TABLET, FILM COATED in 1 BOTTLE (68382-520-05)
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-520-05
Package Description500 TABLET, FILM COATED in 1 BOTTLE (68382-520-05)
Product NDC68382-520
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSirolimus
Non-Proprietary NameSirolimus
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20140115
Marketing Category NameANDA
Application NumberANDA201676
ManufacturerZydus Pharmaceuticals USA 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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