acellular pertussis vaccine, inactivated / diphtheria toxoid vaccine, inactivated / Haemophilus influenzae type b, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine / 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)
Pentacel
Category(s)
other
SPL Type(s)
Vaccine
Master SPL
Sanofi Pasteur Inc. (2013-10-31)
Oldest Current Product
2008-06-20
License(s)
BLA
RxNORM
INJECTION\ACELLULAR PERTUSSIS VACCINE, INACTIVATED:DIPHTHERIA TOXOID VACCINE, INACTIVATED:HAEMOPHILUS INFLUENZAE TYPE B, CAPSULAR POLYSACCHARIDE INACTIVATED TETANUS TOXOID CONJUGATE VACCINE:POLIOVIRUS VACCINE INACTIVATED, TYPE 1 (MAHONEY):POLIOVIRUS VACCINE INACTIVATED, TYPE 2 (MEF-1):POLIOVIRUS VACCINE INACTIVATED, TYPE 3 (SAUKETT):TETANUS TOXOID VACCINE, INACTIVATED

product(s) by strength(s)

0.5 ml acellular pertussis vaccine, inactivated 96 unt/ml / diphtheria toxoid vaccine, inactivated 30 unt/ml / haemophilus influenzae type b, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 68 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 20 unt/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1492810510PentacelBLASanofi Pasteur Inc.2008-06-20125145377116cf-adfe-40b5-b871-3a0fc8b4103e

application(s)

#idtitleapprovedfda division
1125145Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) Reconstituted with Diphtheria and Tetanus Toxoids and Pentacel Application2008-06-20CBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1377116cf-adfe-40b5-b871-3a0fc8b4103e (view SPL)These highlights do not include all the information needed to use Pentacel safely and effectively. See full prescribing information for Pentacel.Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) VaccineSuspension for Intramuscular InjectionInitial U.S. Approval: 2008otherVaccineSanofi Pasteur Inc.MANUFACTURE2013-10-3110492810510

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