SIMPONI ARIA

UNIISPLATC L04AB06

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

Identification

ManufacturerJanssen Biotech, Inc.

CountryUS (United States)

ATC codeL04AB06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5789435001
1 VIAL, SINGLE-DOSE in 1 CARTON (57894-350-01) / 4 mL in 1 VIAL, SINGLE-DOSE
ndc11
5789435089
1 VIAL, SINGLE-DOSE in 1 CARTON (57894-350-89) / 4 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

91X1KLU43E

GOLIMUMAB

RxCUI 819300

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "91X1KLU43E",
    "rxcui": "819300",
    "inchikey": null,
    "display_name": "GOLIMUMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "f86cb4a7-c358-4136-ae57-b32bda9bba00": {
      "match": "brand_token",
      "title": "SIMPONI (GOLIMUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.]",
      "spl_version": "42",
      "published_date": "2026-01-23"
    }
  },
  "productid": "57894-350_3e5ed294-188e-d226-e063-6394a90a5326",
  "productndc": "57894-350",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GOLIMUMAB",
  "proprietary_name": "SIMPONI ARIA",
  "active_ingred_unit": "mg/4mL",
  "application_number": "BLA125433",
  "marketing_category": "BLA",
  "nonproprietary_name": "golimumab",
  "start_marketing_date": "20130719",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code L04AB06.

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