Vaccine Information: Adacel TDaP (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Package

NDC 49281-400-20
Tdap

Tetanus Toxoid, Reduced
Diphtheria Toxoid
and Acellular
Pertussis Vaccine
Adsorbed

5 single-dose
prefilled syringes 0.5 mL each

Rx only

Adacel®

For adolescent and adult use.

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL -- 0.5 mL Syringe Package
(click image for full-size original)
ADACEL TDAP 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 injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-400
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5 [Lf] in 0.5 mL
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 2 [Lf] in 0.5 mL
BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) (BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED)) BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) 2.5 ug in 0.5 mL
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 5 ug in 0.5 mL
BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (BORDETELLA PERTUSSIS PERTACTIN ANTIGEN) BORDETELLA PERTUSSIS PERTACTIN ANTIGEN 3 ug in 0.5 mL
BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN (BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN) BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN 5 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM PHOSPHATE
FORMALDEHYDE
GLUTARAL
PHENOXYETHANOL
Product Characteristics
Color WHITE (WHITE (CLOUDY)) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-400-10 10 VIAL in 1 PACKAGE contains a VIAL (49281-400-58)
1 NDC:49281-400-58 0.5 mL in 1 VIAL This package is contained within the PACKAGE (49281-400-10)
2 NDC:49281-400-05 5 VIAL in 1 PACKAGE contains a VIAL (49281-400-58)
2 NDC:49281-400-58 0.5 mL in 1 VIAL This package is contained within the PACKAGE (49281-400-05)
3 NDC:49281-400-20 5 SYRINGE in 1 PACKAGE contains a SYRINGE (49281-400-89)
3 NDC:49281-400-89 0.5 mL in 1 SYRINGE This package is contained within the PACKAGE (49281-400-20)
4 NDC:49281-400-15 5 SYRINGE in 1 PACKAGE contains a SYRINGE (49281-400-88)
4 NDC:49281-400-88 0.5 mL in 1 SYRINGE This package is contained within the PACKAGE (49281-400-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125111 06/10/2005
Labeler — Sanofi Pasteur Inc. (086723285)
Establishment
Name Address ID/FEI Operations
Sanofi Pasteur Limited 208206623 MANUFACTURE (49281-400)

Revised: 03/2020 Sanofi Pasteur Inc.

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