QUADRACEL

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 · 2

ndc11
4928156410
10 VIAL, SINGLE-USE in 1 PACKAGE (49281-564-10) / .5 mL in 1 VIAL, SINGLE-USE (49281-564-58)
ndc11
4928156415
10 SYRINGE in 1 PACKAGE (49281-564-15) / .5 mL in 1 SYRINGE (49281-564-88)

Annotations

UNII (FDA Substance ID)

8C367IY4EY

BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "8C367IY4EY",
    "rxcui": null,
    "inchikey": null,
    "display_name": "BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "76798bc5-6752-4c02-9f03-68a361eea66b": {
      "match": "brand_token",
      "title": "QUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI VACCINES US INC.]",
      "spl_version": "10",
      "published_date": "2026-04-29"
    }
  },
  "productid": "49281-564_b943f360-e126-45d4-af57-3fcb4c68d1b2",
  "productndc": "49281-564",
  "dosage_form": "INJECTION, SUSPENSION",
  "dea_schedule": null,
  "product_type": "VACCINE",
  "substance_name": "BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)",
  "proprietary_name": "QUADRACEL",
  "active_ingred_unit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [Lf]/.5mL; [Lf]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL",
  "application_number": "BLA125525",
  "marketing_category": "BLA",
  "nonproprietary_name": "diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine",
  "start_marketing_date": "20150324",
  "active_numerator_strength": "20; 5; 3; 20; 5; 15; 29; 7; 26"
}

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