acellular pertussis vaccine, inactivated / diphtheria toxoid vaccine, inactivated / tetanus toxoid vaccine, inactivated Injection

Brand(s)
Adacel, Daptacel
Category(s)
other
SPL Type(s)
Vaccine
Master SPL
Sanofi Pasteur Inc. (2013-10-31)
Oldest Current Product
2002-05-14
License(s)
BLA
RxNORM
INJECTION\ACELLULAR PERTUSSIS VACCINE, INACTIVATED:DIPHTHERIA TOXOID VACCINE, INACTIVATED: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)
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)

product(s) by strength(s)

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250848AdacelBLARemedyrepack Inc.2015-10-19, 2015-11-14BORDETELLA 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)INTRAMUSCULARINJECTION, SUSPENSION492810400125111bed67114-d190-4dfa-8b1b-7fa247834d49, fd8dad15-9b4a-4e34-9bac-b0d4641bfb06

0.5 ml bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.01 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 0.02 mg/ml / diphtheria toxoid vaccine, inactivated 30 unt/ml / tetanus toxoid vaccine, inactivated 10 unt/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1492810286DaptacelBLASanofi Pasteur Inc.2002-05-14BORDETELLA 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)INTRAMUSCULARINJECTION, SUSPENSION10366606f34d0f-4e72-41d3-967f-8abf3f2005c1

application(s)

#idtitleapprovedtradenamesfda division
1103666Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine AdsorbedDaptacel Application2002-05-14CBER
2125111Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed Application2005-06-10ADACELCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
106f34d0f-4e72-41d3-967f-8abf3f2005c1 (view SPL)These highlights do not include all the information needed to use DAPTACEL safely and effectively. See full prescribing information for DAPTACEL.DAPTACEL (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) Suspension for Intramuscular InjectionInitial U.S. Approval: 2002otherVaccineSanofi Pasteur Inc.MANUFACTURE2013-10-318492810286
2bed67114-d190-4dfa-8b1b-7fa247834d49 (view SPL)These highlights do not include all the information needed to use Adacel safely and effectively. See full prescribing information for Adacel.Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed )Suspension for Intramuscular InjectionInitial U.S. Approval: 2005otherVaccineRemedyrepack Inc.2015-11-141521250848
3fd8dad15-9b4a-4e34-9bac-b0d4641bfb06 (view SPL)These highlights do not include all the information needed to use Adacel safely and effectively. See full prescribing information for Adacel.Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed )Suspension for Intramuscular InjectionInitial U.S. Approval: 2005otherVaccineRemedyrepack Inc.2015-10-191521250848

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