Bexsero

UNIISPL

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

Identification

ManufacturerGlaxoSmithKline Biologicals SA

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5816097620
10 SYRINGE in 1 CARTON (58160-976-20) / .5 mL in 1 SYRINGE (58160-976-02)

Annotations

UNII (FDA Substance ID)

25DB599G64

NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN ANTIGEN

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "25DB599G64",
    "rxcui": null,
    "inchikey": null,
    "display_name": "NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN ANTIGEN",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "f70cf2fc-6e6d-4a74-9f7a-db8fec072fd7": {
      "match": "brand_token",
      "title": "BEXSERO (NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN, NEISSERIA MENINGITIDIS SEROGROUP B FHBP FUSION PROTEIN ANTIGEN AND NEISSERIA MENINGITIDIS SEROGROUP B NADA PROTEIN ANTIGEN) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]",
      "spl_version": "11",
      "published_date": "2025-12-25"
    }
  },
  "productid": "58160-976_db17d990-e6e2-450c-b9ed-923ec92df84d",
  "productndc": "58160-976",
  "dosage_form": "INJECTION, SUSPENSION",
  "dea_schedule": null,
  "product_type": "VACCINE",
  "substance_name": "NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN ANTIGEN; NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN ANTIGEN; NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN ANTIGEN; NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 OUTER MEMBRANE VESICLE ANTIGEN",
  "proprietary_name": "Bexsero",
  "active_ingred_unit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
  "application_number": "BLA125546",
  "marketing_category": "BLA",
  "nonproprietary_name": "NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN, NEISSERIA MENINGITIDIS SEROGROUP B FHBP FUSION PROTEIN ANTIGEN and NEISSERIA MENINGITIDIS SEROGROUP B NADA PROTEIN ANTIGEN",
  "start_marketing_date": "20161201",
  "active_numerator_strength": "50; 50; 50; 25"
}

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