"83034-003-65" National Drug Code (NDC)

NDC Code	83034-003-65
Package Description	60 POUCH in 1 CARTON (83034-003-65) / 5 AMPULE in 1 POUCH (83034-003-05) / 2.5 mL in 1 AMPULE
Product NDC	83034-003
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Ohtuvayre
Non-Proprietary Name	Ensifentrine
Dosage Form	SUSPENSION
Usage	RESPIRATORY (INHALATION)
Start Marketing Date	20240626
Marketing Category Name	NDA
Application Number	NDA217389
Manufacturer	Verona Pharma, Inc.
Substance Name	ENSIFENTRINE
Strength	3
Strength Unit	mg/2.5mL
Pharmacy Classes	Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA], Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]