NDC 51224-012

Phentolamine Mesylate

Phentolamine Mesylate

Phentolamine Mesylate is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Tagi Pharma, Inc.. The primary component is Phentolamine Mesylate.

• Product ID: 51224-012_38217e2c-397f-4c16-8b3f-7eae12d8db20
• NDC: 51224-012
• Product Type: Human Prescription Drug
• Proprietary Name: Phentolamine Mesylate
• Generic Name: Phentolamine Mesylate
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2017-07-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207686
• Labeler Name: TAGI Pharma, Inc.
• Substance Name: PHENTOLAMINE MESYLATE
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 51224-012-10

10 CARTON in 1 TRAY (51224-012-10) > 1 VIAL in 1 CARTON (51224-012-20) > 1 INJECTION in 1 VIAL

• Marketing Start Date: 2017-07-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51224-012-20 [51224001220]

Phentolamine Mesylate INJECTION

• Marketing Category: ANDA
• Application Number: ANDA207686
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-07-15

NDC 51224-012-10 [51224001210]

Phentolamine Mesylate INJECTION

• Marketing Category: ANDA
• Application Number: ANDA207686
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-07-15

Drug Details

Active Ingredients

Ingredient	Strength
PHENTOLAMINE MESYLATE	5 mg/1

OpenFDA Data

• SPL SET ID: fe1e10f5-4ff3-4616-9534-489648d88d33
• Manufacturer:
  • TAGI Pharma, Inc.
• UNII:
  • Y7543E5K9T
• RxNorm Concept Unique ID - RxCUI:
  • 1361023
• UPC Code:
  • 0351224012202

Pharmacological Class

• Adrenergic alpha-Antagonists [MoA]
• alpha-Adrenergic Blocker [EPC]

NDC Crossover Matching brand name "Phentolamine Mesylate" or generic name "Phentolamine Mesylate"

NDC	Brand Name	Generic Name
0143-9564	Phentolamine Mesylate	Phentolamine Mesylate
51224-012	Phentolamine Mesylate	Phentolamine Mesylate
68094-101	PHENTOLAMINE MESYLATE	PHENTOLAMINE MESYLATE
0362-0101	Oraverse	Phentolamine Mesylate