NDC Code(s) : 58160-842-01, 58160-842-11, 58160-842-43, 58160-842-52
Packager : GlaxoSmithKline Biologicals SA

Category : VACCINE LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BOOSTRIXTetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed SUSPENSION
Product Information
Product Type VACCINE Item Code (Source) NDC:58160-842
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)(UNII: K3W1N8YP13)
(CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:K3W1N8YP13) 		CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)5 [iU] in 0.5 mL
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)(UNII: IRH51QN26H)
(CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:IRH51QN26H) 		CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)2.5 [iU] in 0.5 mL
BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED)(UNII: QSN5XO8ZSU)
(BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) - UNII:QSN5XO8ZSU) 		BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED)8 ug in 0.5 mL
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)(UNII: 8C367IY4EY)
(BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:8C367IY4EY) 		BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)8 ug in 0.5 mL
BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)(UNII: I05O535NV6)
(BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:I05O535NV6) 		BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)2.5 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
FORMALDEHYDE(UNII: 1HG84L3525)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58160-842-1110 in 1 CARTON
1NDC:58160-842-010.5 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:58160-842-5210 in 1 CARTON
2NDC:58160-842-430.5 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125106 07/24/2009

LABELER - GlaxoSmithKline Biologicals SA(372748392)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 58160-842-11

BOOSTRIX

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed

Tdap

Rx only

For 10 Years of Age and Older

10 x 0.5-mL Single-Dose Vials

GSK

Boostrix

Made in Belgium

©2022 the GSK group of companies or its licensor.

Rev. 2/23

513414

Boostrix 10 count carton