Octagam Immune Globulin (Human)

UNIISPL

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

Identification

ManufacturerPfizer Laboratories Div Pfizer Inc

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0069840002
1 BOTTLE, GLASS in 1 CARTON (0069-8400-02) / 20 mL in 1 BOTTLE, GLASS (0069-8400-01)

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": {
    "fb07257b-e5e2-64c8-666c-65009f0aa604": {
      "match": "brand_token",
      "title": "OCTAGAM IMMUNE GLOBULIN (HUMAN) (IMMUNE GLOBULIN) SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]",
      "spl_version": "3",
      "published_date": "2024-01-30"
    }
  },
  "productid": "0069-8400_a08c35a4-9c25-5ceb-f3c4-0901519057b9",
  "productndc": "0069-8400",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": "HUMAN IMMUNOGLOBULIN G",
  "proprietary_name": "Octagam Immune Globulin (Human)",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA125062",
  "marketing_category": "BLA",
  "nonproprietary_name": "Immune Globulin",
  "start_marketing_date": "20231113",
  "active_numerator_strength": "50"
}

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