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"71288-039-16" National Drug Code (NDC)

Xenleta 6 VIAL, SINGLE-USE in 1 CARTON (71288-039-16) / 15 mL in 1 VIAL, SINGLE-USE (71288-039-15)
(Meitheal Pharmaceuticals Inc.)

NDC Code71288-039-16
Package Description6 VIAL, SINGLE-USE in 1 CARTON (71288-039-16) / 15 mL in 1 VIAL, SINGLE-USE (71288-039-15)
Product NDC71288-039
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameXenleta
Non-Proprietary NameLefamulin Acetate
Dosage FormINJECTION, SOLUTION
UsageINTRAVENOUS
Start Marketing Date20190909
Marketing Category NameNDA
Application NumberNDA211673
ManufacturerMeitheal Pharmaceuticals Inc.
Substance NameLEFAMULIN ACETATE
Strength150
Strength Unitmg/15mL
Pharmacy ClassesCytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Diterpenes [CS], Pleuromutilin Antibacterial [EPC]

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