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United States · US · US:57894-070_02ee9cf4-c6d6-4239-854e-7c5976977456

Simponi

UNIISPLATC L04AB06

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerJanssen Biotech, Inc.
CountryUS (United States)
ATC codeL04AB06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    5789407001
    1 SYRINGE, GLASS in 1 CARTON (57894-070-01) / .5 mL in 1 SYRINGE, GLASS
  • ndc11
    5789407002
    1 SYRINGE in 1 CARTON (57894-070-02) / .5 mL in 1 SYRINGE
  • ndc11
    5789407089
    1 SYRINGE in 1 CARTON (57894-070-89) / .5 mL in 1 SYRINGE
  • ndc11
    5789407090
    1 SYRINGE, GLASS in 1 CARTON (57894-070-90) / .5 mL in 1 SYRINGE, GLASS

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": "SUBCUTANEOUS",
  "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": "57894-070_02ee9cf4-c6d6-4239-854e-7c5976977456",
  "productndc": "57894-070",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GOLIMUMAB",
  "proprietary_name": "Simponi",
  "active_ingred_unit": "mg/.5mL",
  "application_number": "BLA125289",
  "marketing_category": "BLA",
  "nonproprietary_name": "golimumab",
  "start_marketing_date": "20090425",
  "active_numerator_strength": "50"
}

Related drugs

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