"68083-381-01" National Drug Code (NDC)

Irinotecan Hydrochloide 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-381-01) > 2 mL in 1 VIAL, SINGLE-DOSE
(Gland Pharma Limited)

NDC Code68083-381-01
Package Description1 VIAL, SINGLE-DOSE in 1 CARTON (68083-381-01) > 2 mL in 1 VIAL, SINGLE-DOSE
Product NDC68083-381
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameIrinotecan Hydrochloide
Non-Proprietary NameIrinotecan Hydrochloide
Dosage FormINJECTION
UsageINTRAVENOUS
Start Marketing Date20191118
Marketing Category NameANDA
Application NumberANDA212993
ManufacturerGland Pharma Limited
Substance NameIRINOTECAN HYDROCHLORIDE
Strength20
Strength Unitmg/mL
Pharmacy ClassesTopoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]

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