"62484-0015-5" National Drug Code (NDC)

Xromi 1 BOTTLE in 1 CARTON (62484-0015-5) / 148 mL in 1 BOTTLE (62484-0015-4)
(Nova Laboratories, Ltd.)

NDC Code62484-0015-5
Package Description1 BOTTLE in 1 CARTON (62484-0015-5) / 148 mL in 1 BOTTLE (62484-0015-4)
Product NDC62484-0015
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameXromi
Non-Proprietary NameHydroxyurea
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20240404
Marketing Category NameNDA
Application NumberNDA216593
ManufacturerNova Laboratories, Ltd.
Substance NameHYDROXYUREA
Strength100
Strength Unitmg/mL
Pharmacy ClassesAntimetabolite [EPC], Urea [CS]

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