acellular pertussis vaccine, inactivated / diphtheria toxoid vaccine, inactivated / poliovirus vaccine inactivated, type 1 (Mahoney) / poliovirus vaccine inactivated, type 2 (MEF-1) / poliovirus vaccine inactivated, type 3 (Saukett) / tetanus toxoid vaccine, inactivated Injection

Brand(s)
Quadracel
Category(s)
other
SPL Type(s)
Vaccine
Master SPL
Sanofi Pasteur Inc. (2015-03-27)
Oldest Current Product
2015-03-24
License(s)
BLA
RxNORM
INJECTION\ACELLULAR PERTUSSIS VACCINE, INACTIVATED:DIPHTHERIA TOXOID VACCINE, INACTIVATED:POLIOVIRUS VACCINE INACTIVATED, TYPE 1 (MAHONEY):POLIOVIRUS VACCINE INACTIVATED, TYPE 2 (MEF-1):POLIOVIRUS VACCINE INACTIVATED, TYPE 3 (SAUKETT):TETANUS TOXOID VACCINE, INACTIVATED
SPL Active
INTRAMUSCULAR\INJECTION, SUSPENSION\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)
SPL Moiety
INTRAMUSCULAR\INJECTION, SUSPENSION\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)

product(s) by strength(s)

0.5 ml bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.4 mg/ml / bordetella pertussis fimbriae 2/3 vaccine, inactivated 0.01 mg/ml / bordetella pertussis pertactin vaccine, inactivated 0.006 mg/ml / bordetella pertussis toxoid vaccine, inactivated 0.4 mg/ml / diphtheria toxoid vaccine, inactivated 30 unt/ml / poliovirus vaccine inactivated, type 1 (mahoney) 80 unt/ml / poliovirus vaccine inactivated, type 2 (mef-1) 16 unt/ml / poliovirus vaccine inactivated, type 3 (saukett) 64 unt/ml / tetanus toxoid vaccine, inactivated 10 unt/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1492810562QuadracelBLASanofi Pasteur Inc.2015-03-24BORDETELLA 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)INTRAMUSCULARINJECTION, SUSPENSION12552599d971ad-54da-420d-b025-eb2dab8c4ec9

application(s)

#idtitleapprovedtradenamesfda division
1125525Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine Application2015-03-24QuadracelCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
199d971ad-54da-420d-b025-eb2dab8c4ec9 (view SPL)These highlights do not include all the information needed to use Quadracel safely and effectively. See full prescribing information for Quadracel. Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) Suspension for Intramuscular Injection Initial U.S. Approval: 2015otherVaccineSanofi Pasteur Inc.MANUFACTURE2015-03-271492810562

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII