BOOSTRIX
These 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 useInitial U.S. Approval: 2005
Approved
Approval ID
c3c03458-942c-4565-8a9c-1901bb0d2db0
Product Type
VACCINE LABEL
Effective Date
Mar 31, 2025
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-1377
Application NumberBLA125106
Product Classification
M
Marketing Category
C73585
G
Generic Name
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateMarch 31, 2025
FDA Product Classification
INGREDIENTS (9)
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)Active
Quantity: 5 [iU] in 0.5 mL
Code: K3W1N8YP13
Classification: ACTIB
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)Active
Quantity: 2.5 [iU] in 0.5 mL
Code: IRH51QN26H
Classification: ACTIB
BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED)Active
Quantity: 8 ug in 0.5 mL
Code: QSN5XO8ZSU
Classification: ACTIB
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)Active
Quantity: 8 ug in 0.5 mL
Code: 8C367IY4EY
Classification: ACTIB
BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)Active
Quantity: 2.5 ug in 0.5 mL
Code: I05O535NV6
Classification: ACTIB
ALUMINUM HYDROXIDEInactive
Code: 5QB0T2IUN0
Classification: IACT
FORMALDEHYDEInactive
Code: 1HG84L3525
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PEG-20 SORBITAN OLEATEInactive
Code: 6OZP39ZG8H
Classification: IACT