United States· US:0143-9564_264ee71e-7e33-4693-b993-8ee0cc2f8d48
Phentolamine Mesylate
A medicinal product containing phentolamine mesylate, registered in United States by Hikma Pharmaceuticals USA Inc..
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- PHENTOLAMINE MESYLATE
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 4
- ndc1101439564011 VIAL in 1 BOX (0143-9564-01) / 1 mL in 1 VIAL
- ndc11014395641010 VIAL in 1 BOX (0143-9564-10) / 1 mL in 1 VIAL
- ndc110143-9564-01
- ndc110143-9564-10
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Phentolamine mesylate in 5 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomPhentolamine 10mg/1ml solution for injection ampoulesSpecial Order
- CanadaORAVERSESEPTODONT
- FranceORAVERSE 400 microgrammes/1,7 ml, solution injectableSEPTODONT HOLDING
- Japanフェントラミンメシル酸塩ノバルティス ファーマ
- NetherlandsRegitine, 10 mg/ml oplossing voor injectieACE Pharmaceuticals B.V.
Authorised across Europe · EMA
The same active substance is authorised in 5 EEA countries. Names it is sold under:
- Spain · Oraverse
- France · Oraverse
- United Kingdom (Northern Ireland) · Phentolamine Mesilate Roma Pharmaceuticals
- Italy · Oraverse
- Netherlands · Regitine
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/2635ee10-e863-4002-8ec6-d55a73c12087 GET /v1/drugs/2635ee10-e863-4002-8ec6-d55a73c12087?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "INTRAMUSCULAR; INTRAVENOUS",
"source": "ndc",
"strength": "5",
"substance": "PHENTOLAMINE MESYLATE",
"productndc": "0143-9564",
"dosage_form": "INJECTION, POWDER, FOR SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "ANDA040235",
"marketing_category": "ANDA"
}See everything about phentolamine mesylate.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.