PENTACEL

Product NDC
50090-7544
11-digit product format
500907544
Labeler code
50090
Product ID
50090-7544_31b8ff54-fe46-43ea-86ad-10f0459ba654
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
A-S Medication Solutions
Application
BLA125145
Marketing category
BLA
Marketing start
2008-06-20
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PENTACEL
Listing expiration
2026-12-31

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
49281-544-58PENTACEL0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION2.5 mL10 ug in 0.5mL1
49281-561-01PENTACEL0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION2.5 mL7 [D'ag'U] in 0.5mL1
50090-7544-0PENTACEL1 in 1 KITKIT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7544-0EA - Each50090-754455bd822f-e3e5-4d31-87c5-1944dc8a20e612025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7544PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20250523_e7a819d7-a597-4c91-9078-7cd20ac34410.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
49281-544-58492810544580.5 mL in 1 VIAL, SINGLE-DOSE0.5 mlHistorical
49281-561-01492810561010.5 mL in 1 VIAL, SINGLE-DOSE0.5 mlHistorical
50090-7544-0500907544001 KIT in 1 KIT (50090-7544-0) * .5 mL in 1 VIAL, SINGLE-DOSE (49281-561-01) * .5 mL in 1 VIAL, SINGLE-DOSE (49281-544-58) 1 kit2008-06-20NoNoHistorical