Penpulimab

UNIISPL

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

Identification

ManufacturerAkeso Biopharma, Co., Ltd

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8365410501
1 VIAL, SINGLE-DOSE in 1 BOX (83654-105-01) / 10 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

IBS1BZ4E4I

PENPULIMAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "IBS1BZ4E4I",
    "rxcui": null,
    "inchikey": null,
    "display_name": "PENPULIMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "830004e8-31af-4cc6-ab16-e870cab1c5ca": {
      "match": "brand_token",
      "title": "PENPULIMAB KCQX (PENPULIMAB) INJECTION [AKESO BIOPHARMA, CO., LTD]",
      "spl_version": "1",
      "published_date": "2025-04-30"
    }
  },
  "productid": "83654-105_3392cd59-0d45-e081-e063-6394a90a0353",
  "productndc": "83654-105",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PENPULIMAB",
  "proprietary_name": "Penpulimab",
  "active_ingred_unit": "mg/10mL",
  "application_number": "BLA761258",
  "marketing_category": "BLA",
  "nonproprietary_name": "Penpulimab",
  "start_marketing_date": "20250423",
  "active_numerator_strength": "100"
}

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