NDC Code(s) : 49281-820-10, 49281-800-83
Packager : Sanofi Pasteur Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TETANUS TOXOID ADSORBEDCLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49281-820
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 [Lf] in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM(UNII: CPD4NFA903)0.25 mg in 0.5 mL
FORMALDEHYDE(UNII: 1HG84L3525)
THIMEROSAL(UNII: 2225PI3MOV)0.3 ug in 0.5 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49281-820-1010 in 1 PACKAGE
10.5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103913 09/23/2005
TETANUS TOXOID ADSORBEDCLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49281-800
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 [Lf] in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM(UNII: CPD4NFA903)0.25 mg in 0.5 mL
FORMALDEHYDE(UNII: 1HG84L3525)
THIMEROSAL(UNII: 2225PI3MOV)25 ug in 0.5 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49281-800-831 in 1 PACKAGE
15 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103913 09/23/2005

PRINCIPAL DISPLAY PANEL

NDC 49281-820-10

Tetanus
Toxoid
Adsorbed

TTOX
1 Dose
(0.5 mL)

Rx only

Preservative-free

Mfd by: Sanofi Pasteur Inc.

PRINCIPAL DISPLAY PANEL - 0.5 mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 49281-820-10

TTOX

Tetanus Toxoid
Adsorbed

10 VIALS
1 Dose
each

Preservative-free

Tetanus Toxoid should not be used
for the treatment of tetanus.

Rx only

sanofi pasteur

PRINCIPAL DISPLAY PANEL - 10 Vial Carton