TREMFYA

UNIISPLATC L04AC16

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

Identification

ManufacturerJanssen Biotech, Inc.

CountryUS (United States)

ATC codeL04AC16

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
5789465102
1 SYRINGE in 1 CARTON (57894-651-02) / 2 mL in 1 SYRINGE (57894-651-01)
ndc11
5789465104
2 CARTON in 1 CARTON (57894-651-04) / 1 SYRINGE in 1 CARTON (57894-651-02) / 2 mL in 1 SYRINGE (57894-651-01)
ndc11
5789465122
1 SYRINGE in 1 CARTON (57894-651-22) / 2 mL in 1 SYRINGE (57894-651-11)
ndc11
5789465192
1 SYRINGE in 1 CARTON (57894-651-92) / 2 mL in 1 SYRINGE (57894-651-99)

Annotations

UNII (FDA Substance ID)

089658A12D

GUSELKUMAB

RxCUI 1928588

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "089658A12D",
    "rxcui": "1928588",
    "inchikey": null,
    "display_name": "GUSELKUMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56": {
      "match": "brand_token",
      "title": "TREMFYA (GUSELKUMAB) INJECTION TREMFYA (GUSELKUMAB) INJECTION [JANSSEN BIOTECH, INC.]",
      "spl_version": "28",
      "published_date": "2026-02-13"
    }
  },
  "productid": "57894-651_ebe07a22-1b8b-4403-99dc-e7f34308d5d0",
  "productndc": "57894-651",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GUSELKUMAB",
  "proprietary_name": "TREMFYA",
  "active_ingred_unit": "mg/2mL",
  "application_number": "BLA761061",
  "marketing_category": "BLA",
  "nonproprietary_name": "guselkumab",
  "start_marketing_date": "20240911",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code L04AC16.

Access this data programmatically

Query TREMFYA and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs