FDA.reportPublic FDA data

BOOSTRIX

Product NDC
50090-1377
11-digit product format
500901377
Labeler code
50090
Product ID
50090-1377_2e2b4c6a-d397-41b8-babf-adc104e8fbef
Type
VACCINE
Nonproprietary name
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
Dosage form
SUSPENSION
Route
INTRAMUSCULAR
Labeler
A-S Medication Solutions
Application
BLA125106
Marketing category
BLA
Marketing start
2009-07-24
Substance
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)
Active strength
8; 2.5; 8; 5; 2.5 ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL
Pharmacologic classes
Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)8 ug/.5mL
BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)2.5 ug/.5mL
BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED)8 ug/.5mL
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)5 [iU]/.5mL
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)2.5 [iU]/.5mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1377-02023-06-22C16284748780-1f386c64a-2198-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BOOSTRIX safely and effectively. See full prescribing information for BOOSTRIX. BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) injectable suspension, for intramuscular use Initial U.S. Approval: 2005
50090-1377-12023-06-22C16284748780-1f386c64a-2198-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BOOSTRIX safely and effectively. See full prescribing information for BOOSTRIX. BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) injectable suspension, for intramuscular use Initial U.S. Approval: 2005
50090-1377-02023-01-30C16284748780-1f386c64a-2198-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BOOSTRIX safely and effectively. See full prescribing information for BOOSTRIX. BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) injectable suspension, for intramuscular use Initial U.S. Approval: 2005
50090-1377-12023-01-30C16284748780-1f386c64a-2198-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BOOSTRIX safely and effectively. See full prescribing information for BOOSTRIX. BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) injectable suspension, for intramuscular use Initial U.S. Approval: 2005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1377-0BOOSTRIX10 in 1 CARTONSUSPENSION1026
50090-1377-1BOOSTRIX.5 mL in 1 SYRINGESUSPENSION.526
50090-1377-1BOOSTRIX1 in 1 POUCHSUSPENSION126
50090-1377-2BOOSTRIX.5 mL in 1 SYRINGESUSPENSION.526

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1377-0ML - Milliliter50090-137706671d8b-8810-4dec-bcb5-05bc6333001b12018-10-11
50090-1377-1ML - Milliliter50090-1377ec4e7a78-9b0d-4257-8465-ef7fd4c021a312018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1377BOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE, ADSORBED) SUSPENSION [A-S MEDICATION SOLUTIONS]26Current NDC, Legacy NDC, 4 package rows20250508_c3c03458-942c-4565-8a9c-1901bb0d2db0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1300370BOOSTRIX vaccine 0.5 ML Prefilled SyringePSNc3c03458-942c-4565-8a9c-1901bb0d2db026
1300368Tdap (generic for Boostrix) 0.5 ML Prefilled SyringePSNc3c03458-942c-4565-8a9c-1901bb0d2db026
13003700.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.016 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.005 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.016 MG/ML / diphtheria toxoid vaccine, inactivated 5 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Prefilled Syringe [Boostrix]SBDc3c03458-942c-4565-8a9c-1901bb0d2db026
13003680.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.016 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.005 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.016 MG/ML / diphtheria toxoid vaccine, inactivated 5 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Prefilled SyringeSCDc3c03458-942c-4565-8a9c-1901bb0d2db026
1300370Boostrix (Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 8 MCG / Bordetella pertussis pertactin vaccine, inactivated 2.5 MCG / Bordetella pertussis toxoid vaccine, inactivated 8 MCG / diphtheria toxoid vaccine, inactivated 2.5 UNT / tetanus toxoid vaccine, inactivated 5 UNT) per 0.5 ML Prefilled SyringeSYc3c03458-942c-4565-8a9c-1901bb0d2db026
1300370Boostrix Tdap (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) 0.5 ML Prefilled SyringeSYc3c03458-942c-4565-8a9c-1901bb0d2db026
1300368Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 8 MCG / Bordetella pertussis pertactin vaccine, inactivated 2.5 MCG / Bordetella pertussis toxoid vaccine, inactivated 8 MCG / diphtheria toxoid vaccine, inactivated 2.5 UNT / tetanus toxoid vaccine, inactivated 5 UNT per 0.5 ML Prefilled SyringeSYc3c03458-942c-4565-8a9c-1901bb0d2db026
1300368Tdap (tetanus toxoid vaccine, inactivated 5 UNT / diphtheria toxoid vaccine, inactivated 2.5 UNT / acellular pertussis vaccine, inactivated 18.5 MCG) per 0.5 ML Prefilled SyringeSYc3c03458-942c-4565-8a9c-1901bb0d2db026
1300368tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Tdap generic for Boostrix) 0.5 ML Prefilled SyringeSYc3c03458-942c-4565-8a9c-1901bb0d2db026

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1377-05009013770010 SYRINGE in 1 CARTON (50090-1377-0) / .5 mL in 1 SYRINGE (50090-1377-2) 10 syringe2009-07-240000-00-00NoNoCurrent
50090-1377-1500901377011 SYRINGE in 1 POUCH (50090-1377-1) / .5 mL in 1 SYRINGE1 syringe2009-07-240000-00-00NoNoCurrent
50090-1377-250090137702.5 mL in 1 SYRINGEHistorical