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United States· US:49702-250_9a0bc98a-3305-43f1-85bf-fb1e9ba88d45

Rukobia

A other antivirals product containing fostemsavir tromethamine, registered in United States by ViiV Healthcare Company. The same ATC class is registered in 4 of our 19 countries.

ATC J05AXOrange 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…normalisedRukobiaATCJ05AXREGISTER NO.US:49702-250_9a0bc98a…PACKS LISTED1CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about fostemsavir tromethamineAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Fostemsavir tromethamine is registered in 4 of 19 countries.

Countries holding a registration under ATC J05AX (other antivirals), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 1 of them publish a price we can compare per daily dose
Search fostemsavir tromethamine products by name

Fostemsavir tromethamine · ATC J05AX

4 / 19 countries

  • Canada
  • Ireland
  • Netherlands
  • 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
fostemsavir tromethamine
Manufacturer
ViiV Healthcare Company
Country
United States (US)
ATC code
J05AX
ATC class
Other antivirals
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 1

  • ndc11
    4970225018
    1 BOTTLE in 1 CARTON (49702-250-18) / 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Regulatory notes

UNII (FDA substance ID)
2X513P36U0
FOSTEMSAVIR TROMETHAMINE
RxCUI 2380374
Orange Book
N212950
DailyMed SPL labels
1 version tracked

Same medicine, other countries

Fostemsavir tromethamine in 14 other countries

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

All fostemsavir tromethamine products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Rukobia
  • Liechtenstein · Rukobia
  • Norway · Rukobia

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/77c330e9-2e6d-4057-acac-5731c3c67785
GET /v1/drugs/77c330e9-2e6d-4057-acac-5731c3c67785?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": "2X513P36U0",
    "rxcui": "2380374",
    "inchikey": "RRGJSMBMTOKHTE-UHFFFAOYSA-N",
    "display_name": "FOSTEMSAVIR TROMETHAMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 5
  },
  "spl_meta": {
    "a21006b7-6d6f-4f06-81b4-17978756452b": {
      "match": "brand_token",
      "title": "RUKOBIA (FOSTEMSAVIR TROMETHAMINE) TABLET, FILM COATED, EXTENDED RELEASE [VIIV HEALTHCARE COMPANY]",
      "spl_version": "8",
      "published_date": "2025-06-12"
    }
  },
  "productid": "49702-250_9a0bc98a-3305-43f1-85bf-fb1e9ba88d45",
  "productndc": "49702-250",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "212950",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 600MG BASE",
        "product_no": "001",
        "approval_date": "Jul 2, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FOSTEMSAVIR TROMETHAMINE",
  "proprietary_name": "Rukobia",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA212950",
  "marketing_category": "NDA",
  "nonproprietary_name": "fostemsavir tromethamine",
  "start_marketing_date": "20200702",
  "active_numerator_strength": "600"
}
API referenceMCP serverPlans

See everything about fostemsavir tromethamine.

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.

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