"65219-670-01" National Drug Code (NDC)

Bomyntra 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-670-01) / 1.7 mL in 1 VIAL, SINGLE-DOSE
(Fresenius Kabi USA, LLC)

NDC Code65219-670-01
Package Description1 VIAL, SINGLE-DOSE in 1 CARTON (65219-670-01) / 1.7 mL in 1 VIAL, SINGLE-DOSE
Product NDC65219-670
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBomyntra
Non-Proprietary NameDenosumab
Dosage FormINJECTION
UsageSUBCUTANEOUS
Start Marketing Date20250630
Marketing Category NameBLA
Application NumberBLA761398
ManufacturerFresenius Kabi USA, LLC
Substance NameDENOSUMAB
Strength70
Strength Unitmg/mL
Pharmacy ClassesRANK Ligand Blocking Activity [MoA], RANK Ligand Inhibitor [EPC]

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