Arexvy

SPL

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
5816089415
1 KIT in 1 CARTON (58160-894-15) * .5 mL in 1 VIAL (58160-719-03) * .5 mL in 1 SYRINGE (58160-749-07)

Annotations

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "1e50f275-002e-413f-a840-66ee3cb3740c": {
      "match": "brand_token",
      "title": "AREXVY (RESPIRATORY SYNCYTIAL VIRUS VACCINE RECOMBINANT, ADJUVANTED) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]",
      "spl_version": "10",
      "published_date": "2026-05-25"
    }
  },
  "productid": "58160-894_2522c052-d323-459d-b9fd-76de846bc127",
  "productndc": "58160-894",
  "dosage_form": "KIT",
  "dea_schedule": null,
  "product_type": "VACCINE",
  "substance_name": null,
  "proprietary_name": "Arexvy",
  "active_ingred_unit": null,
  "application_number": "BLA125775",
  "marketing_category": "BLA",
  "nonproprietary_name": "Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted",
  "start_marketing_date": "20260430",
  "active_numerator_strength": null
}

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