FDA.reportPublic FDA data

PENTACEL

Product NDC
49281-510
11-digit product format
492810510
Labeler code
49281
Product ID
49281-510_a5a98618-c6d0-4358-8c65-13cb5b126ff0
Type
VACCINE
Nonproprietary name
DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE
Dosage form
KIT
Labeler
Sanofi Pasteur Inc.
Application
BLA125145
Marketing category
BLA
Marketing start
2008-06-20
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49281-510DDiscontinued by firm2026-07-31
excluded packagepackage49281-51049281-510-05DDiscontinued by firm2026-07-31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49281-510-05EA - Each49281-510023760c9-a124-4646-8b96-624df51c4b0d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENT8C367IY4EYPENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGENACTIVE INGREDIENT1O0600285APENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
BORDETELLA PERTUSSIS PERTACTIN ANTIGENACTIVE INGREDIENT63GD90PP8XPENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED)ACTIVE INGREDIENTF4TN0IPY37PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENTK3W1N8YP13PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENTIRH51QN26HPENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGENACTIVE INGREDIENTFLV5I5W26RPENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENT0LVY784C09PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENT23JE9KDF4RPENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENT459ROM8M9MPENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETY8C367IY4EYPENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGENACTIVE MOIETY1O0600285APENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
BORDETELLA PERTUSSIS PERTACTIN ANTIGENACTIVE MOIETY63GD90PP8XPENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED)ACTIVE MOIETYF4TN0IPY37PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETYK3W1N8YP13PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETYIRH51QN26HPENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGENACTIVE MOIETYFLV5I5W26RPENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETY0LVY784C09PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETY23JE9KDF4RPENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETY459ROM8M9MPENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
ALBUMIN BOVINEINACTIVE INGREDIENT27432CM55QPENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
ALUMINUM PHOSPHATEINACTIVE INGREDIENTF92V3S521OPENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
FORMALDEHYDEINACTIVE INGREDIENT1HG84L3525PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
GLUTARALINACTIVE INGREDIENTT3C89M417NPENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
NEOMYCININACTIVE INGREDIENTI16QD7X297PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TPENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
POLYMYXIN B SULFATEINACTIVE INGREDIENT19371312D4PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10
WATERINACTIVE INGREDIENT059QF0KO0RPENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]10

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125145PentacelDiphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine351(a)Rx2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49281-510-05492810510051 KIT in 1 PACKAGE (49281-510-05) * .5 mL in 1 VIAL, SINGLE-DOSE (49281-560-05) * .5 mL in 1 VIAL, SINGLE-DOSE (49281-548-58) 1 kit2008-06-200000-00-00NoNoCurrent