HYPERHEP B

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
1353363601
1 VIAL, GLASS in 1 CARTON (13533-636-01) / 1 mL in 1 VIAL, GLASS (13533-636-10)
ndc11
1353363602
1 SYRINGE, GLASS in 1 CARTON (13533-636-02) / 1 mL in 1 SYRINGE, GLASS (13533-636-20)
ndc11
1353363603
1 SYRINGE, GLASS in 1 CARTON (13533-636-03) / .5 mL in 1 SYRINGE, GLASS (13533-636-30)
ndc11
1353363605
1 VIAL, GLASS in 1 CARTON (13533-636-05) / 5 mL in 1 VIAL, GLASS (13533-636-50)

Annotations

UNII (FDA Substance ID)

XII270YC6M

HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN

RxCUI 26744

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "XII270YC6M",
    "rxcui": "26744",
    "inchikey": null,
    "display_name": "HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "cda35690-672f-46cd-8520-e37f4d66a8d7": {
      "match": "brand_token",
      "title": "HYPERHEP B (HEPATITIS B IMMUNE GLOBULIN (HUMAN)) INJECTION [GRIFOLS USA, LLC]",
      "spl_version": "26",
      "published_date": "2024-10-04"
    }
  },
  "productid": "13533-636_07a45b19-8ed3-48e2-9c0f-9620437fd452",
  "productndc": "13533-636",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": "HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN",
  "proprietary_name": "HYPERHEP B",
  "active_ingred_unit": "[iU]/mL",
  "application_number": "BLA101146",
  "marketing_category": "BLA",
  "nonproprietary_name": "HEPATITIS B IMMUNE GLOBULIN (HUMAN)",
  "start_marketing_date": "19961009",
  "active_numerator_strength": "220"
}

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