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United States · US · US:63361-243_899b15fd-89c2-44ab-95c8-a457ea7cf0be

VAXELIS

UNIISPL

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

Identification

ManufacturerMSP Vaccine Company
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6336124315
    10 SYRINGE in 1 PACKAGE (63361-243-15) / .5 mL in 1 SYRINGE (63361-243-88)

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": {
    "3ed8472a-c6eb-4076-9d66-025ede589e3d": {
      "match": "brand_token",
      "title": "VAXELIS (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS, INACTIVATED POLIOVIRUS, HAEMOPHILUS B CONJUGATE AND HEPATITIS B VACCINE) INJECTION, SUSPENSION [MSP VACCINE COMPANY]",
      "spl_version": "14",
      "published_date": "2026-05-06"
    }
  },
  "productid": "63361-243_899b15fd-89c2-44ab-95c8-a457ea7cf0be",
  "productndc": "63361-243",
  "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); HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN; HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)",
  "proprietary_name": "VAXELIS",
  "active_ingred_unit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL",
  "application_number": "BLA125563",
  "marketing_category": "BLA",
  "nonproprietary_name": "diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine",
  "start_marketing_date": "20181221",
  "active_numerator_strength": "20; 5; 3; 20; 5; 15; 3; 10; 29; 7; 26"
}

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