Medicine
Phentolamine 5 mg/mL powder for injection
Phentolamine 5 mg/mL powder for injection is a generic prescription medicine for intramuscular, intravenous use, 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
Store at 20° to 25° C (68° to 77° F).
Key facts
- Active ingredient (INN)
- Phentolamine
- Brand
- Sold under the generic name
- Strength
- 5 mg/mL
- Dosage form
- Powder for injection
- Route
- Intramuscular, intravenous
- Packs
- 1 vial, 10 vials
- Manufacturer
- Hikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25° C (68° to 77° F).
- 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
- 15 May 1998
- Identifiers
- RxCUI 1361023DailyMed set ID ed6c506c-5535-4b7c-ae1a-d63f09d796c9NDC 0143-9564Application ANDA040235
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 |
|---|---|---|---|
| 1 vial in 1 box / 1 mL in 1 vial | 0143-9564-01 | Hikma Pharmaceuticals | 4 November 2015 |
| 10 vial in 1 box / 1 mL in 1 vial | 0143-9564-10 | Hikma Pharmaceuticals | 4 November 2015 |
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 Phentolamine 5 mg/mL powder for 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.