HepaGam B

UNIISPL

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

Identification

ManufacturerKamada Ltd.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4959105151
1 VIAL, GLASS in 1 CARTON (49591-051-51) / 5 mL in 1 VIAL, GLASS (49591-051-05)

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; INTRAVENOUS",
  "spl_meta": {
    "0146011c-944b-4251-8a5f-e573a3d5f8c0": {
      "match": "brand_token",
      "title": "HEPAGAM B (HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN) INJECTION, SOLUTION [KAMADA LTD.]",
      "spl_version": "4",
      "published_date": "2026-03-04"
    }
  },
  "productid": "49591-051_4c139c86-d0dc-1a10-e063-6294a90a8e1d",
  "productndc": "49591-051",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": "HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN",
  "proprietary_name": "HepaGam B",
  "active_ingred_unit": "[iU]/mL",
  "application_number": "BLA125035",
  "marketing_category": "BLA",
  "nonproprietary_name": "HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN",
  "start_marketing_date": "20251001",
  "active_numerator_strength": "312"
}

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