GAMMAGARD Liquid ERC

UNIISPL

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

Identification

ManufacturerTakeda Pharmaceuticals America, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0944270510
1 VIAL, GLASS in 1 CARTON (0944-2705-10) / 100 mL in 1 VIAL, GLASS (0944-2705-01)
ndc11
0944270550
1 VIAL, GLASS in 1 CARTON (0944-2705-50) / 50 mL in 1 VIAL, GLASS (0944-2705-05)

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; SUBCUTANEOUS",
  "spl_meta": {
    "9d42adca-0dd7-4df7-864d-5a7feee52130": {
      "match": "brand_token",
      "title": "GAMMAGARD LIQUID (IMMUNE GLOBULIN INFUSION (HUMAN)) INJECTION, SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "22",
      "published_date": "2025-12-12"
    }
  },
  "productid": "0944-2705_2332ff1f-1311-4aaa-9d76-9a011b3f7956",
  "productndc": "0944-2705",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": "HUMAN IMMUNOGLOBULIN G",
  "proprietary_name": "GAMMAGARD Liquid ERC",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA125105",
  "marketing_category": "BLA",
  "nonproprietary_name": "Immune Globulin Infusion (Human)",
  "start_marketing_date": "20250714",
  "active_numerator_strength": "100"
}

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