Gamunex-C

UNIISPL

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

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
1353380501
1 BAG in 1 CARTON (13533-805-01) / 50 mL in 1 BAG (13533-805-00)
ndc11
1353380511
1 BAG in 1 CARTON (13533-805-11) / 100 mL in 1 BAG (13533-805-10)
ndc11
1353380531
1 BAG in 1 CARTON (13533-805-31) / 200 mL in 1 BAG (13533-805-30)
ndc11
1353380545
1 BAG in 1 CARTON (13533-805-45) / 400 mL in 1 BAG (13533-805-44)

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": "INTRAVENOUS",
  "spl_meta": {
    "4fe97dac-d952-40f5-9c6a-67cda048ad8f": {
      "match": "brand_token",
      "title": "GAMUNEX-C (IMMUNE GLOBULIN (HUMAN)) INJECTION [GRIFOLS USA, LLC]",
      "spl_version": "3",
      "published_date": "2026-05-11"
    }
  },
  "productid": "13533-805_2c4ac1fc-ff0d-408c-95a7-dd90712d71bb",
  "productndc": "13533-805",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": "HUMAN IMMUNOGLOBULIN G",
  "proprietary_name": "Gamunex-C",
  "active_ingred_unit": "g/100mL",
  "application_number": "BLA125046",
  "marketing_category": "BLA",
  "nonproprietary_name": "Immune Globulin (Human)",
  "start_marketing_date": "20101013",
  "active_numerator_strength": "10"
}

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