NDC Code(s) : 50090-1831-9, 50090-1831-0
Packager : A-S Medication Solutions

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:50090-1831(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:50090-1831-010 in 1 POUCH
1NDC:50090-1831-9.5 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125106 07/24/2009

LABELER - A-S Medication Solutions(830016429)

Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-1831)

PRINCIPAL DISPLAY PANEL

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