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United States · US · US:70461-025_0677b781-d088-4d71-ba38-765049878fbb

FLUAD

UNIISPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSeqirus, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7046102503
    10 SYRINGE, GLASS in 1 CARTON (70461-025-03) / .5 mL in 1 SYRINGE, GLASS (70461-025-04)

Annotations

UNII (FDA Substance ID)
HQW9FZS4YK
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "HQW9FZS4YK",
    "rxcui": null,
    "inchikey": null,
    "display_name": "INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "9dbbf304-7be3-4417-8285-a8f5fd20f977": {
      "match": "brand_token",
      "title": "FLUAD (INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SEQIRUS, INC.]",
      "spl_version": "13",
      "published_date": "2025-07-08"
    }
  },
  "productid": "70461-025_0677b781-d088-4d71-ba38-765049878fbb",
  "productndc": "70461-025",
  "dosage_form": "INJECTION, SUSPENSION",
  "dea_schedule": null,
  "product_type": "VACCINE",
  "substance_name": "INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED)",
  "proprietary_name": "FLUAD",
  "active_ingred_unit": "ug/.5mL; ug/.5mL; ug/.5mL",
  "application_number": "BLA125510",
  "marketing_category": "BLA",
  "nonproprietary_name": "INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED)",
  "start_marketing_date": "20250701",
  "active_numerator_strength": "15; 15; 15"
}

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