"68382-245-05" National Drug Code (NDC)

Imatinib Mesylate 500 TABLET, FILM COATED in 1 BOTTLE (68382-245-05)
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-245-05
Package Description500 TABLET, FILM COATED in 1 BOTTLE (68382-245-05)
Product NDC68382-245
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameImatinib Mesylate
Non-Proprietary NameImatinib Mesylate
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20210121
Marketing Category NameANDA
Application NumberANDA210658
ManufacturerZydus Pharmaceuticals USA Inc.
Substance NameIMATINIB MESYLATE
Strength400
Strength Unitmg/1
Pharmacy ClassesBcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]

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