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United States · US · US:59148-400_9aa886b0-669e-48d4-9f37-a160d78f69c6

VOYXACT

UNIISPLATC L04AG

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

Identification

ManufacturerOtsuka America Pharmaceutical, Inc.
CountryUS (United States)
ATC codeL04AG
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5914840075
    1 SYRINGE in 1 CARTON (59148-400-75) / 2 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)
GHX28QZ7DD
SIBEPRENLIMAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "GHX28QZ7DD",
    "rxcui": null,
    "inchikey": null,
    "display_name": "SIBEPRENLIMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "c8a93b32-0676-4704-86dc-cb65f425c6e5": {
      "match": "brand_token",
      "title": "VOYXACT (SIBEPRENLIMAB) INJECTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]",
      "spl_version": "3",
      "published_date": "2026-03-18"
    }
  },
  "productid": "59148-400_9aa886b0-669e-48d4-9f37-a160d78f69c6",
  "productndc": "59148-400",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SIBEPRENLIMAB",
  "proprietary_name": "VOYXACT",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA761434",
  "marketing_category": "BLA",
  "nonproprietary_name": "sibeprenlimab",
  "start_marketing_date": "20251125",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code L04AG.

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