United States· US:83368-075_7f954669-af25-4d50-8430-36dcc77fd78f

Ryzumvi

A phentolamine product containing phentolamine mesylate, registered in United States by Oyster Point Pharma, Inc.. The same ATC class is registered in 6 of our 19 countries.

ATC C04AB01Orange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedRyzumviATCC04AB01REGISTER NO.US:83368-075_7f954669…PACKS LISTED2CHECKEDJune 3, 2026

Where it is registered

Phentolamine is registered in 6 of 19 countries.

Countries holding a registration under ATC C04AB01 (phentolamine), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 2 of them publish a price we can compare per daily dose

Phentolamine · ATC C04AB01

6 / 19 countries

  • Canada
  • Finlandprice
  • Japan
  • Netherlands
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
phentolamine mesylate
Manufacturer
Oyster Point Pharma, Inc.
Country
United States (US)
ATC code
C04AB01
ATC class
Phentolamine
Defined daily dose
10 mg, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 2

  • ndc11
    8336807530
    6 POUCH in 1 CARTON (83368-075-30) / 5 VIAL, SINGLE-USE in 1 POUCH / .31 mL in 1 VIAL, SINGLE-USE
  • ndc11
    8336807531
    1 POUCH in 1 CARTON (83368-075-31) / 5 VIAL, SINGLE-USE in 1 POUCH / .31 mL in 1 VIAL, SINGLE-USE

Regulatory notes

UNII (FDA substance ID)
Y7543E5K9T
PHENTOLAMINE MESYLATE
RxCUI 227240
Orange Book
N217064
DailyMed SPL labels
1 version tracked

Interactions

182 interactions on record for phentolamine.

Graded by severity as the source publishes them — 1 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Phentolamine · interactions on record

182 records

  • 1 severe
  • 167 moderate
  • 14 minor

Most severe, free to view

  • TizanidineM03BX02severe
  • DimenhydrinatA04AB02moderate
  • ThiethylperazinA04AB03moderate
  • DiphenhydraminA04AB05moderate
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Phentolamine in 5 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All phentolamine products

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/476a7335-9af7-490e-9e45-8d36d2c4cdf7
GET /v1/drugs/476a7335-9af7-490e-9e45-8d36d2c4cdf7?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.

{
  "unii": {
    "unii": "Y7543E5K9T",
    "rxcui": "227240",
    "inchikey": "OGIYDFVHFQEFKQ-UHFFFAOYSA-N",
    "display_name": "PHENTOLAMINE MESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "96bb1e53-c2cc-4e60-a21a-db0269c371bf": {
      "match": "brand_token",
      "title": "RYZUMVI (PHENTOLAMINE MESYLATE) SOLUTION/ DROPS [OYSTER POINT PHARMA, INC.]",
      "spl_version": "4",
      "published_date": "2024-11-25"
    }
  },
  "productid": "83368-075_7f954669-af25-4d50-8430-36dcc77fd78f",
  "productndc": "83368-075",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "217064",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.75% BASE",
        "product_no": "001",
        "approval_date": "Sep 25, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PHENTOLAMINE MESYLATE",
  "proprietary_name": "Ryzumvi",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA217064",
  "marketing_category": "NDA",
  "nonproprietary_name": "phentolamine mesylate",
  "start_marketing_date": "20240325",
  "active_numerator_strength": "10"
}

See everything about phentolamine.

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.