"83090-011-01" National Drug Code (NDC)

Daptomycin 1 VIAL, SINGLE-DOSE in 1 CARTON (83090-011-01) / 10 mL in 1 VIAL, SINGLE-DOSE
(Sintetica US LLC)

NDC Code83090-011-01
Package Description1 VIAL, SINGLE-DOSE in 1 CARTON (83090-011-01) / 10 mL in 1 VIAL, SINGLE-DOSE
Product NDC83090-011
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDaptomycin
Non-Proprietary NameDaptomycin
Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
UsageINTRAVENOUS
Start Marketing Date20231105
Marketing Category NameANDA
Application NumberANDA215890
ManufacturerSintetica US LLC
Substance NameDAPTOMYCIN
Strength500
Strength Unitmg/20mL
Pharmacy ClassesLipopeptide Antibacterial [EPC], Lipopeptides [CS]

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