Cyltezo

SPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0597040089
2 KIT in 1 CARTON (0597-0400-89) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .2 mL in 1 SYRINGE * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET

Annotations

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "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": "0597-0400_72dd9ccf-66f7-47a4-b6e4-4bb2f9a1caa3",
  "productndc": "0597-0400",
  "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": "20230701",
  "active_numerator_strength": null
}

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