HyperRAB

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 · 3

ndc11
1353331801
1 VIAL in 1 CARTON (13533-318-01) / 1 mL in 1 VIAL (13533-318-10)
ndc11
1353331803
1 VIAL in 1 CARTON (13533-318-03) / 3 mL in 1 VIAL (13533-318-30)
ndc11
1353331805
1 VIAL in 1 CARTON (13533-318-05) / 5 mL in 1 VIAL (13533-318-50)

Annotations

UNII (FDA Substance ID)

95F619ATQ2

HUMAN RABIES VIRUS IMMUNE GLOBULIN

RxCUI 89886

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "95F619ATQ2",
    "rxcui": "89886",
    "inchikey": null,
    "display_name": "HUMAN RABIES VIRUS IMMUNE GLOBULIN",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INFILTRATION; INTRAMUSCULAR",
  "spl_meta": {
    "f82880b8-998c-4659-8f20-6dcc81f258e9": {
      "match": "brand_token",
      "title": "HYPERRAB (RABIES IMMUNE GLOBULIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC]",
      "spl_version": "10",
      "published_date": "2024-10-07"
    }
  },
  "productid": "13533-318_880a0273-4487-4f86-a949-2c91898bdd78",
  "productndc": "13533-318",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": "HUMAN RABIES VIRUS IMMUNE GLOBULIN",
  "proprietary_name": "HyperRAB",
  "active_ingred_unit": "[iU]/mL",
  "application_number": "BLA101144",
  "marketing_category": "BLA",
  "nonproprietary_name": "Rabies Immune Globulin (Human)",
  "start_marketing_date": "19740612",
  "active_numerator_strength": "300"
}

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