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United States · US · US:13533-810_3d491d8b-7fa0-47e4-bec0-4fe6d944fa25

XEMBIFY

UNIISPL

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

Identification

ManufacturerGRIFOLS USA, LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    1353381005
    1 VIAL in 1 CARTON (13533-810-05) / 5 mL in 1 VIAL (13533-810-06)
  • ndc11
    1353381010
    1 VIAL in 1 CARTON (13533-810-10) / 10 mL in 1 VIAL (13533-810-11)
  • ndc11
    1353381020
    1 VIAL in 1 CARTON (13533-810-20) / 20 mL in 1 VIAL (13533-810-21)
  • ndc11
    1353381050
    1 VIAL in 1 CARTON (13533-810-50) / 50 mL in 1 VIAL (13533-810-51)

Annotations

UNII (FDA Substance ID)
66Y330CJHS
HUMAN IMMUNOGLOBULIN G
RxCUI 1426680
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "66Y330CJHS",
    "rxcui": "1426680",
    "inchikey": null,
    "display_name": "HUMAN IMMUNOGLOBULIN G",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "8c174b11-a061-412e-a3b2-7bf7e1adaace": {
      "match": "brand_token",
      "title": "XEMBIFY (IMMUNE GLOBULIN SUBCUTANEOUS, HUMAN-KLHW) SOLUTION [GRIFOLS USA, LLC]",
      "spl_version": "12",
      "published_date": "2025-03-24"
    }
  },
  "productid": "13533-810_3d491d8b-7fa0-47e4-bec0-4fe6d944fa25",
  "productndc": "13533-810",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": "HUMAN IMMUNOGLOBULIN G",
  "proprietary_name": "XEMBIFY",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA125683",
  "marketing_category": "BLA",
  "nonproprietary_name": "immune globulin subcutaneous, human-klhw",
  "start_marketing_date": "20190703",
  "active_numerator_strength": "200"
}

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