Active ingredient
Phentolamine
4 finished FDA listings contain Phentolamine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PHENTOLAMINE MESYLATE
- Dosage forms
- Injection, Injection, Powder, For Solution, Injection, Solution, Solution/ Drops
- Routes
- Intramuscular, Intravenous, Ophthalmic, Submucosal
- Manufacturers / labelers
- 4
- Strengths listed
- .235 mg/ml · 10 mg/ml · 5 mg/1 · 5 mg/ml
- Brand names in FDA listings
- Oraverse, Ryzumvi
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 8153
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 040235 | HIKMA | 1998-03-11 | 1 |
| NDA 022159 | SEPTODONT HOLDING | 2008-05-09 | 1 |
| ANDA 207686 | PRECISION DOSE INC | 2017-07-14 | 1 |
| NDA 217064 | FAMYGEN LIFE SCI | 2023-09-25 | 1 |
Official labeling on DailyMed
- RYZUMVI (PHENTOLAMINE MESYLATE) SOLUTION/ DROPS [OYSTER POINT PHARMA, INC.] · version 7 · 2026-07-01
- PHENTOLAMINE MESYLATE INJECTION [PRECISION DOSE INC.] · version 12 · 2024-08-23
- PHENTOLAMINE MESYLATE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 9 · 2024-03-18
- ORAVERSE (PHENTOLAMINE MESYLATE) INJECTION, SOLUTION [SEPTODONT, INC.] · version 4 · 2018-12-06
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.