Octagam Immune Globulin (Human)

UNIISPL

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

Identification

ManufacturerOctapharma USA Inc

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6898285001
20 mL in 1 BOTTLE, GLASS (68982-850-01)
ndc11
6898285002
50 mL in 1 BOTTLE, GLASS (68982-850-02)
ndc11
6898285003
100 mL in 1 BOTTLE, GLASS (68982-850-03)
ndc11
6898285004
200 mL in 1 BOTTLE, GLASS (68982-850-04)
ndc11
6898285005
300 mL in 1 BOTTLE, GLASS (68982-850-05)

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": "68982-850_3341403e-ae11-5eae-adf5-63ebc0703d25",
  "productndc": "68982-850",
  "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": "20040521",
  "active_numerator_strength": "100"
}

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