PHENTOLAMINE MESYLATE
Phentolamine Mesylate for Injection USP, 5mg
Approved
Approval ID
e146c7ee-d2fa-433c-8768-0945e4ff0990
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2024
Manufacturers
FDA
Precision Dose Inc.
DUNS: 035886746
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 Code68094-101
Application NumberANDA207686
Product Classification
M
Marketing Category
C73584
G
Generic Name
PHENTOLAMINE MESYLATE
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJanuary 23, 2024
FDA Product Classification
INGREDIENTS (3)
PHENTOLAMINE MESYLATEActive
Quantity: 5 mg in 1 1
Code: Y7543E5K9T
Classification: ACTIB
MANNITOLInactive
Quantity: 25 mg in 1 1
Code: 3OWL53L36A
Classification: IACT
Natural Latex RubberInactive
Quantity: 0 1 in 1 1
Code: 2LQ0UUW8IN
Classification: CNTM