"68083-195-01" National Drug Code (NDC)

Dexrazoxane 1 VIAL in 1 CARTON (68083-195-01) / 50 mL in 1 VIAL
(Gland Pharma Limited)

NDC Code68083-195-01
Package Description1 VIAL in 1 CARTON (68083-195-01) / 50 mL in 1 VIAL
Product NDC68083-195
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDexrazoxane
Non-Proprietary NameDexrazoxane For Injection
Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
UsageINTRAVENOUS
Start Marketing Date20161205
Marketing Category NameANDA
Application NumberANDA207321
ManufacturerGland Pharma Limited
Substance NameDEXRAZOXANE HYDROCHLORIDE
Strength500
Strength Unitmg/50mL
Pharmacy ClassesCytoprotective Agent [EPC]

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