Oraverse
These highlights do not include all the information needed to use OraVerse™ safely and effectively. See full prescribing information for OraVerse. OraVerse (phentolamine mesylate) InjectionInitial U.S. Approval: 1952
Approved
Approval ID
4025cf98-ea87-4531-b0fc-6283c84f63f3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2018
Manufacturers
FDA
Septodont, Inc.
DUNS: 627058738
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phentolamine Mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0362-0101
Application NumberNDA022159
Product Classification
M
Marketing Category
C73594
G
Generic Name
Phentolamine Mesylate
Product Specifications
Route of AdministrationSUBMUCOSAL
Effective DateDecember 5, 2018
FDA Product Classification
INGREDIENTS (8)
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Edetate DisodiumInactive
Quantity: 0.5 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
Sodium AcetateInactive
Quantity: 1.36 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
MannitolInactive
Quantity: 50 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
Phentolamine MesylateActive
Quantity: 0.235 mg in 1 mL
Code: Y7543E5K9T
Classification: ACTIB
Acetic AcidInactive
Code: Q40Q9N063P
Classification: IACT
NitrogenInactive
Code: N762921K75
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT