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FDA Product

BOOSTRIX

Product approved by U.S. Food and Drug Administration (US)

Basic Information

BOOSTRIX

50090-1377

Regulatory Information

50090-1377

BLA125106

C73585

March 31, 2025

USA

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

VACCINE LABEL

26

Company Information

830016429

Active Ingredients

CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)

Quantity: 5 [iU] in 0.5 mL

Code: K3W1N8YP13

Class Code: ACTIB

CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)

Quantity: 2.5 [iU] in 0.5 mL

Code: IRH51QN26H

Class Code: ACTIB

BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED)

Quantity: 8 ug in 0.5 mL

Code: QSN5XO8ZSU

Class Code: ACTIB

BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)

Quantity: 8 ug in 0.5 mL

Code: 8C367IY4EY

Class Code: ACTIB

BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)

Quantity: 2.5 ug in 0.5 mL

Code: I05O535NV6

Class Code: ACTIB

ALUMINUM HYDROXIDE

Code: 5QB0T2IUN0

Class Code: IACT

FORMALDEHYDE

Code: 1HG84L3525

Class Code: IACT

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

PEG-20 SORBITAN OLEATE

Code: 6OZP39ZG8H

Class Code: IACT

Active Moieties

CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)

Code: K3W1N8YP13

CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)

Code: IRH51QN26H

BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED)

Code: QSN5XO8ZSU

BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)

Code: 8C367IY4EY

BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)

Code: I05O535NV6

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