"82090-001-01" National Drug Code (NDC)

NDC Code	82090-001-01
Package Description	1 KIT in 1 CARTON (82090-001-01) / 1 POUCH in 1 KIT / 2 SYRINGE in 1 POUCH / 575 mg in 1 SYRINGE
Product NDC	82090-001
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Risvan
Non-Proprietary Name	Risperidone
Dosage Form	INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE
Usage	INTRAMUSCULAR
Start Marketing Date	20241201
Marketing Category Name	NDA
Application Number	NDA214835
Manufacturer	Laboratorios Farmaceuticos Rovi, S.A.
Substance Name	RISPERIDONE
Strength	75
Strength Unit	mg/575mg
Pharmacy Classes	Atypical Antipsychotic [EPC]