Phentolamine Mesylate
Phentolamine Mesylate for Injection USP, 5mg
Approved
Approval ID
fe1e10f5-4ff3-4616-9534-489648d88d33
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 17, 2021
Manufacturers
FDA
TAGI Pharma, Inc.
DUNS: 963322560
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 Code51224-012
Application NumberANDA207686
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phentolamine Mesylate
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateDecember 17, 2021
FDA Product Classification
INGREDIENTS (3)
Natural Latex RubberInactive
Quantity: 0 1 in 1 1
Code: 2LQ0UUW8IN
Classification: CNTM
MannitolInactive
Quantity: 25 mg in 1 1
Code: 3OWL53L36A
Classification: IACT
Phentolamine MesylateActive
Quantity: 5 mg in 1 1
Code: Y7543E5K9T
Classification: ACTIB