CUVITRU

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 · 5

ndc11
0944285001
1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-01) / 5 mL in 1 VIAL, SINGLE-USE (0944-2850-02)
ndc11
0944285003
1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-03) / 10 mL in 1 VIAL, SINGLE-USE (0944-2850-04)
ndc11
0944285005
1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-05) / 20 mL in 1 VIAL, SINGLE-USE (0944-2850-06)
ndc11
0944285007
1 VIAL, SINGLE-USE in 1 CARTON (0944-2850-07) / 40 mL in 1 VIAL, SINGLE-USE (0944-2850-08)
ndc11
0944285009
1 BOTTLE, GLASS in 1 CARTON (0944-2850-09) / 50 mL in 1 BOTTLE, GLASS (0944-2850-10)

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": {
    "9aad7ec9-6097-4805-8f1b-898bec35f218": {
      "match": "brand_token",
      "title": "CUVITRU (IMMUNE GLOBULIN SUBCUTANEOUS (HUMAN)) INJECTION, SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "19",
      "published_date": "2025-12-05"
    }
  },
  "productid": "0944-2850_195585b0-5cd1-4638-9765-224db70d6e44",
  "productndc": "0944-2850",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": "HUMAN IMMUNOGLOBULIN G",
  "proprietary_name": "CUVITRU",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA125596",
  "marketing_category": "BLA",
  "nonproprietary_name": "Immune Globulin Subcutaneous (Human)",
  "start_marketing_date": "20161018",
  "active_numerator_strength": "200"
}

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