Drug
Who makes phentolamine mesylate?
4 companies list phentolamine mesylate as a human prescription drug, including under the names Oraverse, Ryzumvi. Forms: injection; injection, powder, for solution; injection, solution; solution/ drops. Routes: intramuscular, intravenous, ophthalmic, submucosal.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing phentolamine mesylate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc.United States | injection, powder, for solution | ANDAANDA040235 | 1 | 4 |
| Precision Dose Inc.United States | injection | ANDAANDA207686 | 1 | 1 |
| Septodont SASFrance | injection, solution | NDANDA022159 | 1 | 1 |
| Oyster Point Pharma, Inc. | solution/ drops | NDANDA217064 | 1 | 0 |
Bulk ingredient listings
- Apicore US LLCIndia · 3 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 2 NDC
- AX Pharmaceutical CorpCanada · 1 NDC
- Darmerica, LLCUnited States · 1 NDC
- Galenova IncCanada · 1 NDC
- Industriale Chimica SRLItaly · 1 NDC
- Kalchem International Inc.United States · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- Matrix Pharmacorp Private LimitedIndia · 1 NDC
- NuCare Pharmaceuticals,Inc.United States · 1 NDC
- Pharma Source Direct, LLCUnited States · 1 NDC
- QINGDAO TIDA BIOTEK CO.,LTD · 1 NDC
- Qingdao Biopeptek Co LtdChina · 1 NDC
- Qingdao Qinzeyuan Biotechnology Co LtdChina · 1 NDC
- RAKSHIT DRUGS PRIVATE LIMITEDIndia · 1 NDC
- Reliable Biopharmaceutical, LLCUnited States · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
Orange Book patents
11 unexpired patents list phentolamine mesylate as the active ingredient, expiring between Jan 2034 and Oct 2039. Application holder: FAMYGEN LIFE SCIENCES INC.
Enquiry
Common questions
- Who makes phentolamine mesylate?
- 4 companies list phentolamine mesylate as a human prescription drug in the openFDA NDC Directory, led by Hikma Pharmaceuticals USA Inc., Precision Dose Inc., Septodont SAS, Oyster Point Pharma, Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Oraverse?
- 2 companies list phentolamine mesylate under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies phentolamine mesylate active ingredient?
- 17 companies list phentolamine mesylate as a bulk ingredient, including Apicore US LLC, Professional Compounding Centers of America dba PCCA, AX Pharmaceutical Corp, Darmerica, LLC.