Medicine
Oraverse 0.3995 mg/1.7 mL injection
Oraverse 0.3995 mg/1.7 mL injection is a prescription medicine containing Phentolamine for submucosal use, marketed by Septodont, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not permit to freeze. Store at controlled room temperature, 20-25°C…
Key facts
- Active ingredient (INN)
- Phentolamine
- Brand
- Oraverse
- Strength
- 0.3995 mg/1.7 mL
- Dosage form
- Injection
- Route
- Submucosal
- Packs
- 10 cartridges of 1.7 mL
- Marketing authorisation holder
- Septodont
- Manufacturer
- Septodont
- Origin register
- US FDA, United States
- Storage
- Do not permit to freeze. Store at controlled room temperature, 20-25°C (68-77°F) with brief excursions permitted between 15-30°C (59-86°F) Protect from direct heat and light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C04AB01 Phentolamine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 June 2011
- Identifiers
- RxCUI 1361019, 1361021DailyMed set ID 4025cf98-ea87-4531-b0fc-6283c84f63f3NDC 0362-0101Application NDA022159
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 10 cartridge in 1 carton / 1.7 mL in 1 cartridge | 0362-0101-10 | Septodont | 1 June 2011 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 30 January 1952 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Phentolamine
Clinical summary
Phentolamine is an alpha-adrenergic blocker indicated for adult and pediatric patients ages 3 years and older for the reversal of soft-tissue anesthesia, i.e., among other approved uses. MedsAcross supplies Phentolamine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about PhentolamineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Oraverse prescribing information (Septodont) · U.S. National Library of Medicine, DailyMed
Need Oraverse 0.3995 mg/1.7 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.