CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS PERTACTIN ANTIGEN, and BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN - FDA Product

Basic Information

Product Name

CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS PERTACTIN ANTIGEN, and BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN

FDA Product Code

50090-1079

Regulatory Information

NDC Product Code

50090-1079

Application Number

BLA125111

Marketing Category

C73585

Effective Date

October 22, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use Adacel safely and effectively. See full prescribing information for Adacel. Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed), Suspension for Intramuscular Injection Initial U.S. Approval: 2005

Labeling Type

VACCINE LABEL

Version Number

Active Ingredients

CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)

Quantity: 2 [Lf] in 0.5 mL

Code: IRH51QN26H

Class Code: ACTIB

BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED)

Quantity: 2.5 ug in 0.5 mL

Code: F4TN0IPY37

Class Code: ACTIB

BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)

Quantity: 5 ug in 0.5 mL

Code: 8C367IY4EY

Class Code: ACTIB

PHENOXYETHANOL

Quantity: 3.3 mg in 0.5 mL

Code: HIE492ZZ3T

Class Code: IACT

CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)

Quantity: 5 [Lf] in 0.5 mL

Code: K3W1N8YP13

Class Code: ACTIB

BORDETELLA PERTUSSIS PERTACTIN ANTIGEN

Quantity: 3 ug in 0.5 mL

Code: 63GD90PP8X

Class Code: ACTIB

BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN

Quantity: 5 ug in 0.5 mL

Code: 1O0600285A

Class Code: ACTIB

ALUMINUM PHOSPHATE

Quantity: 1.5 mg in 0.5 mL

Code: F92V3S521O

Class Code: IACT

FORMALDEHYDE

Quantity: 5 ug in 0.5 mL

Code: 1HG84L3525

Class Code: IACT

GLUTARAL

Quantity: 50 ng in 0.5 mL

Code: T3C89M417N

Class Code: IACT

Active Moieties