NDC 0362-0101

Oraverse

Phentolamine Mesylate

Oraverse is a Submucosal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Septodont, Inc.. The primary component is Phentolamine Mesylate.

• Product ID: 0362-0101_f0465990-acce-46dc-9290-344dab1e4f2f
• NDC: 0362-0101
• Product Type: Human Prescription Drug
• Proprietary Name: Oraverse
• Generic Name: Phentolamine Mesylate
• Dosage Form: Injection, Solution
• Route of Administration: SUBMUCOSAL
• Marketing Start Date: 2011-06-01
• Marketing Category: NDA / NDA
• Application Number: NDA022159
• Labeler Name: Septodont, Inc.
• Substance Name: PHENTOLAMINE MESYLATE
• Active Ingredient Strength: 0 mg/mL
• Pharm Classes: Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0362-0101-10

10 CARTRIDGE in 1 CARTON (0362-0101-10) > 1.7 mL in 1 CARTRIDGE

• Marketing Start Date: 2011-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0362-0101-10 [00362010110]

Oraverse INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA022159
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-06-01

NDC 0362-0101-50 [00362010150]

Oraverse INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA022159
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-06-01
• Marketing End Date: 2018-12-05

Drug Details

Active Ingredients

Ingredient	Strength
PHENTOLAMINE MESYLATE	.235 mg/mL

OpenFDA Data

• SPL SET ID: 4025cf98-ea87-4531-b0fc-6283c84f63f3
• Manufacturer:
  • Septodont, Inc.
• UNII:
  • Y7543E5K9T
• RxNorm Concept Unique ID - RxCUI:
  • 1361019
  • 1361021

Pharmacological Class

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

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

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