FDA.reportPublic FDA data

PENTACEL

Product NDC
49281-511
11-digit product format
492810511
Labeler code
49281
Product ID
49281-511_2bddb5e4-99aa-49c6-9e9d-719e87c1ad22
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 Vaccines US Inc.
Application
BLA125145
Marketing category
BLA
Marketing start
2008-06-20
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PENTACEL
Listing expiration
2027-12-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49281-511-05PENTACEL1 in 1 PACKAGEKIT113
49281-544-58PENTACEL0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION2.5 mL10 ug in 0.5mL13
49281-561-01PENTACEL0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION2.5 mL26 [D'ag'U] in 0.5mL13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49281-511-05EA - Each49281-5110c3dfe2e-2c0a-4f04-b9ac-52357c2e671712020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49281-511PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.]9Current NDC, Legacy NDC, 3 package rows20250403_67d5c665-ca88-49ba-b7d3-7145d9878cf0.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1300468ActHIB vaccine 0.5 ML InjectionPSN67d5c665-ca88-49ba-b7d3-7145d9878cf013
2585714DTaP-vIPV/Hib 0.5 ML InjectionPSN67d5c665-ca88-49ba-b7d3-7145d9878cf013
1300466Haemophilus b conjugate vaccine (tetanus toxoid conjugate) (Hib generic for ActHIB) 0.5 mL InjectionPSN67d5c665-ca88-49ba-b7d3-7145d9878cf013
2585717Pentacel (with vIPV) vaccine 0.5 ML InjectionPSN67d5c665-ca88-49ba-b7d3-7145d9878cf013
25857170.5 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) 58 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 14 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 52 UNT/ML / tetanus toxoid vaccine, inactivated 20 UNT/ML Injection [Pentacel]SBD67d5c665-ca88-49ba-b7d3-7145d9878cf013
13004680.5 ML Haemophilus influenzae type b strain 1482, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 0.068 MG/ML Injection [ActHIB]SBD67d5c665-ca88-49ba-b7d3-7145d9878cf013
25857140.5 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) 58 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 14 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 52 UNT/ML / tetanus toxoid vaccine, inactivated 20 UNT/ML InjectionSCD67d5c665-ca88-49ba-b7d3-7145d9878cf013
13004660.5 ML Haemophilus influenzae type b strain 1482, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 0.068 MG/ML InjectionSCD67d5c665-ca88-49ba-b7d3-7145d9878cf013
13004680.5 ML ActHIB 0.068 MG/ML InjectionSY67d5c665-ca88-49ba-b7d3-7145d9878cf013
1300468ActHIB (purified capsular polysaccharide 10 MCG conjugated to inactivated tetanus toxoid 24 MCG) per 0.5 ML InjectionSY67d5c665-ca88-49ba-b7d3-7145d9878cf013
1300468ActHIB 34 MCG per 0.5 ML InjectionSY67d5c665-ca88-49ba-b7d3-7145d9878cf013
2585714DTaP-IPV/Hib (diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus (vIPV) and Haemophilus b conjugate (tetanus toxoid conjugate)) 0.5 ML InjectionSY67d5c665-ca88-49ba-b7d3-7145d9878cf013
2585717Pentacel DTaP-IPV/Hib (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus (vIPV) and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)) 0.5 ML InjectionSY67d5c665-ca88-49ba-b7d3-7145d9878cf013
1300466purified capsular polysaccharide 10 MCG conjugated to inactivated tetanus toxoid 24 MCG per 0.5 ML InjectionSY67d5c665-ca88-49ba-b7d3-7145d9878cf013
1300468ActHIB vaccine 0.5 ML InjectionPSNe7a819d7-a597-4c91-9078-7cd20ac344101
2585714DTaP-vIPV/Hib 0.5 ML InjectionPSNe7a819d7-a597-4c91-9078-7cd20ac344101
1300466Haemophilus b conjugate vaccine (tetanus toxoid conjugate) (Hib generic for ActHIB) 0.5 mL InjectionPSNe7a819d7-a597-4c91-9078-7cd20ac344101
2585717Pentacel (with vIPV) vaccine 0.5 ML InjectionPSNe7a819d7-a597-4c91-9078-7cd20ac344101
25857170.5 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) 58 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 14 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 52 UNT/ML / tetanus toxoid vaccine, inactivated 20 UNT/ML Injection [Pentacel]SBDe7a819d7-a597-4c91-9078-7cd20ac344101
13004680.5 ML Haemophilus influenzae type b strain 1482, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 0.068 MG/ML Injection [ActHIB]SBDe7a819d7-a597-4c91-9078-7cd20ac344101
25857140.5 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) 58 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 14 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 52 UNT/ML / tetanus toxoid vaccine, inactivated 20 UNT/ML InjectionSCDe7a819d7-a597-4c91-9078-7cd20ac344101
13004660.5 ML Haemophilus influenzae type b strain 1482, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 0.068 MG/ML InjectionSCDe7a819d7-a597-4c91-9078-7cd20ac344101
13004680.5 ML ActHIB 0.068 MG/ML InjectionSYe7a819d7-a597-4c91-9078-7cd20ac344101
1300468ActHIB (purified capsular polysaccharide 10 MCG conjugated to inactivated tetanus toxoid 24 MCG) per 0.5 ML InjectionSYe7a819d7-a597-4c91-9078-7cd20ac344101
1300468ActHIB 34 MCG per 0.5 ML InjectionSYe7a819d7-a597-4c91-9078-7cd20ac344101
2585714DTaP-IPV/Hib (diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus (vIPV) and Haemophilus b conjugate (tetanus toxoid conjugate)) 0.5 ML InjectionSYe7a819d7-a597-4c91-9078-7cd20ac344101
2585717Pentacel DTaP-IPV/Hib (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus (vIPV) and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)) 0.5 ML InjectionSYe7a819d7-a597-4c91-9078-7cd20ac344101
1300466purified capsular polysaccharide 10 MCG conjugated to inactivated tetanus toxoid 24 MCG per 0.5 ML InjectionSYe7a819d7-a597-4c91-9078-7cd20ac344101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49281-511-05492810511051 KIT in 1 PACKAGE (49281-511-05) * .5 mL in 1 VIAL, SINGLE-DOSE (49281-561-01) * .5 mL in 1 VIAL, SINGLE-DOSE (49281-544-58) 1 kit2008-06-200000-00-00NoNoCurrent
49281-544-58492810544580.5 mL in 1 VIAL, SINGLE-DOSE0.5 mlHistorical
49281-561-01492810561010.5 mL in 1 VIAL, SINGLE-DOSE0.5 mlHistorical