United States· US:69448-018_450dafe8-f537-6303-e063-6394a90aa784

IMULDOSA

A interleukin inhibitors product containing ustekinumab-srlf, registered in United States by Accord BioPharma Inc.. The same ATC class is registered in 3 of our 19 countries.

ATC L04ACUS 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…normalisedIMULDOSAATCL04ACREGISTER NO.US:69448-018_450dafe8…PACKS LISTED1CHECKEDJune 3, 2026

Where it is registered

Ustekinumab-srlf is registered in 3 of 19 countries.

Countries holding a registration under ATC L04AC (interleukin inhibitors), 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

Ustekinumab-srlf · ATC L04AC

3 / 19 countries

  • Belgiumprice
  • Ireland
  • 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
ustekinumab-srlf
Manufacturer
Accord BioPharma Inc.
Country
United States (US)
ATC code
L04AC
ATC class
Interleukin inhibitors
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    6944801863
    1 BLISTER PACK in 1 CARTON (69448-018-63) / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE

Regulatory notes

DailyMed SPL labels
1 version tracked

Same medicine, other countries

Ustekinumab-srlf in 16 other countries

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

All ustekinumab-srlf products

Authorised across Europe · EMA

The same active substance is authorised in 4 EEA countries. Names it is sold under:

  • United Kingdom (Northern Ireland) · Imuldosa, Uzpruvo
  • Iceland · Fymskina, Imuldosa
  • Liechtenstein · Fymskina, Imuldosa
  • Norway · Fymskina, Imuldosa

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/f381edd7-6bb8-4627-93dc-d9112ad8442d
GET /v1/drugs/f381edd7-6bb8-4627-93dc-d9112ad8442d?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": "SUBCUTANEOUS",
  "spl_meta": {
    "2539a6cf-0fe5-1565-e063-6294a90a3618": {
      "match": "brand_token",
      "title": "IMULDOSA (USTEKINUMAB-SRLF) INJECTION [ACCORD BIOPHARMA INC.]",
      "spl_version": "9",
      "published_date": "2025-12-04"
    }
  },
  "productid": "69448-018_450dafe8-f537-6303-e063-6394a90aa784",
  "productndc": "69448-018",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "USTEKINUMAB-SRLF",
  "proprietary_name": "IMULDOSA",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA761364",
  "marketing_category": "BLA",
  "nonproprietary_name": "ustekinumab-srlf",
  "start_marketing_date": "20241014",
  "active_numerator_strength": "90"
}

See everything about ustekinumab-srlf.

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.