"63323-762-57" National Drug Code (NDC)

Topotecan Hydrochloride 5 BOX in 1 CARTON (63323-762-57) > 1 VIAL in 1 BOX > 4 mL in 1 VIAL
(Fresenius Kabi USA, LLC)

NDC Code63323-762-57
Package Description5 BOX in 1 CARTON (63323-762-57) > 1 VIAL in 1 BOX > 4 mL in 1 VIAL
Product NDC63323-762
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTopotecan Hydrochloride
Non-Proprietary NameTopotecan Hydrochloride
Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
UsageINTRAVENOUS
Start Marketing Date20150916
End Marketing Date20160318
Marketing Category NameANDA
Application NumberANDA091376
ManufacturerFresenius Kabi USA, LLC
Substance NameTOPOTECAN HYDROCHLORIDE
Strength4
Strength Unitmg/4mL
Pharmacy ClassesTopoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]

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