BOOSTRIX

Product NDC
50090-1831
11-digit product format
500901831
Labeler code
50090
Product ID
50090-1831_8e96021c-e64e-4b03-af42-52891dc7fe39
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1831-0BOOSTRIX10 in 1 POUCHSUSPENSION1019
50090-1831-9BOOSTRIX.5 mL in 1 VIALSUSPENSION.519

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1831-0ML - Milliliter50090-1831b90bb273-17d8-44e6-9e39-43a430219fd812021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1831BOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE, ADSORBED) SUSPENSION [A-S MEDICATION SOLUTIONS]19Current NDC, Legacy NDC, 2 package rows20231129_46993726-584e-4907-ac4d-94e59b236b82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1300378BOOSTRIX vaccine 0.5 ML InjectionPSN46993726-584e-4907-ac4d-94e59b236b8219
1300377tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Tdap generic for Boostrix) 0.5 ML InjectionPSN46993726-584e-4907-ac4d-94e59b236b8219
13003780.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.016 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.005 UNT/ML / Bordetella pertussis toxoid vaccine, inactivated 0.016 MG/ML / diphtheria toxoid vaccine, inactivated 5 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Injection [Boostrix]SBD46993726-584e-4907-ac4d-94e59b236b8219
13003770.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.016 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.005 UNT/ML / Bordetella pertussis toxoid vaccine, inactivated 0.016 MG/ML / diphtheria toxoid vaccine, inactivated 5 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML InjectionSCD46993726-584e-4907-ac4d-94e59b236b8219
1300378Boostrix (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 InjectionSY46993726-584e-4907-ac4d-94e59b236b8219
1300378Boostrix Tdap (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) InjectionSY46993726-584e-4907-ac4d-94e59b236b8219
1300377Bordetella 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 5 UNT per 0.5 ML InjectionSY46993726-584e-4907-ac4d-94e59b236b8219
1300377Tdap (tetanus toxoid vaccine, inactivated 5 UNT / diphtheria toxoid vaccine, inactivated 2.5 UNT / acellular pertussis vaccine, inactivated 18.5 MCG) per 0.5 ML InjectionSY46993726-584e-4907-ac4d-94e59b236b8219

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1831-05009018310010 VIAL in 1 POUCH (50090-1831-0) / .5 mL in 1 VIAL (50090-1831-9) 10 vial2009-07-240000-00-00NoNoCurrent
50090-1831-950090183109.5 mL in 1 VIALHistorical