NDC 0362-0101 – Oraverse
Phentolamine Mesylate .235 mg/mL · Injection, Solution · Submucosal
Product NDC0362-0101
Product details
- Brand name
- Oraverse
- Generic name
- Phentolamine Mesylate
- Labeler
- Septodont, Inc.
- Dosage form
- Injection, Solution
- Route
- Submucosal
- Marketing category
- NDA · NDA022159
- Marketed since
- June 1, 2011
- Listing expires
- December 31, 2026
- Pharmacologic class
- alpha-Adrenergic Blocker
Active ingredients
- Phentolamine Mesylate .235 mg/mL
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 0362-0101-10 | 10 CARTRIDGE in 1 CARTON (0362-0101-10) / 1.7 mL in 1 CARTRIDGE | Jun 1, 2011 |
Recalls mentioning this NDC
- D-0234-2026 Dec 24, 2025 · Class II
Defective container: cracked/broken cartridges - D-0828-2018 May 16, 2018 · Class III
Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance (Phentolamide), a known degradation product impurity…