United States· US:0597-0485_72dd9ccf-66f7-47a4-b6e4-4bb2f9a1caa3

Cyltezo

A medicinal product containing adalimumab-adbm, registered in United States by Boehringer Ingelheim Pharmaceuticals, Inc..

US 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…normalisedCyltezoATC—REGISTER NO.US:0597-0485_72dd9ccf…PACKS LISTED1CHECKEDJune 3, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
adalimumab-adbm
Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    0597048520
    2 KIT in 1 CARTON (0597-0485-20) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (0597-0480-12) / .4 mL in 1 SYRINGE * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET

Regulatory notes

DailyMed SPL labels
1 version tracked

Same medicine, other countries

Adalimumab-adbm in 15 other countries

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

All adalimumab-adbm products

Authorised across Europe · EMA

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

  • United Kingdom (Northern Ireland) · Hukyndra, Humira
  • Iceland · Amgevita, Amsparity
  • Liechtenstein · Amsparity, Hefiya
  • Norway · Amgevita, Amsparity

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/ded803a3-1798-4551-b01c-53828fb29783
GET /v1/drugs/ded803a3-1798-4551-b01c-53828fb29783?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": null,
  "spl_meta": {
    "115ea79b-7209-7f19-b35d-36ec0828fbf5": {
      "match": "brand_token",
      "title": "CYLTEZO (ADALIMUMAB-ADBM) KIT [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]",
      "spl_version": "17",
      "published_date": "2026-03-09"
    }
  },
  "productid": "0597-0485_72dd9ccf-66f7-47a4-b6e4-4bb2f9a1caa3",
  "productndc": "0597-0485",
  "dosage_form": "KIT",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Cyltezo",
  "active_ingred_unit": null,
  "application_number": "BLA761058",
  "marketing_category": "BLA",
  "nonproprietary_name": "adalimumab-adbm",
  "start_marketing_date": "20240430",
  "active_numerator_strength": null
}

See everything about adalimumab-adbm.

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.