"71288-037-10" National Drug Code (NDC)

Xenleta 10 TABLET, COATED in 1 BLISTER PACK (71288-037-10)
(Meitheal Pharmaceuticals Inc.)

NDC Code71288-037-10
Package Description10 TABLET, COATED in 1 BLISTER PACK (71288-037-10)
Product NDC71288-037
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameXenleta
Non-Proprietary NameLefamulin Acetate
Dosage FormTABLET, COATED
UsageORAL
Start Marketing Date20190909
Marketing Category NameNDA
Application NumberNDA211672
ManufacturerMeitheal Pharmaceuticals Inc.
Substance NameLEFAMULIN ACETATE
Strength600
Strength Unitmg/1
Pharmacy ClassesCytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Diterpenes [CS], Pleuromutilin Antibacterial [EPC]

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