FLUZONE TRIVALENT NORTHERN HEMISPHERE

UNIISPL

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

Identification

ManufacturerSanofi Vaccines US Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4928164315
1 VIAL, MULTI-DOSE in 1 PACKAGE (49281-643-15) / 5 mL in 1 VIAL, MULTI-DOSE (49281-643-78)

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": {
    "96ca1b4c-67bf-3db6-24c5-c4841b073c66": {
      "match": "brand_token",
      "title": "FLUZONE HD TIV SH 2026 (INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), AND INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI VACCINES US INC.]",
      "spl_version": "14",
      "published_date": "2026-05-11"
    }
  },
  "productid": "49281-643_499121a9-d080-4783-8654-940b8a83456f",
  "productndc": "49281-643",
  "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/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)",
  "proprietary_name": "FLUZONE TRIVALENT NORTHERN HEMISPHERE",
  "active_ingred_unit": "ug/.5mL; ug/.5mL; ug/.5mL",
  "application_number": "BLA103914",
  "marketing_category": "BLA",
  "nonproprietary_name": "INFLUENZA A VIRUS A/Victoria/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136/RV/2023 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)",
  "start_marketing_date": "20250701",
  "active_numerator_strength": "15; 15; 15"
}

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