NDC Code(s) : 49281-545-03
Packager : Sanofi Pasteur Inc.

Category : VACCINE LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ActHIBHAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN KIT
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-545
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
FORMALDEHYDE(UNII: 1HG84L3525)
Sodium Chloride(UNII: 451W47IQ8X)4 mg in 1 mL
Water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49281-545-031 in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103935 03/30/1993

LABELER - Sanofi Pasteur Inc.(086723285)

Establishment
Name Address ID/FEI Business Operations
Sanofi Pasteur SA 578763542 MANUFACTURE

Establishment
Name Address ID/FEI Business Operations
Sanofi Pasteur Inc. 086723285 MANUFACTURE

PRINCIPAL DISPLAY PANEL

NDC 49281-545-03

Hib

Haemophilus b
Conjugate Vaccine
(Tetanus Toxoid Conjugate)
ActHIB®

For children 2 months through 5 years of age

5
single-
dose
vials

Rx only

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL - Kit Carton

PRINCIPAL DISPLAY PANEL

NDC 49281-547-58
Hib
single-dose (0.5 mL)

Not to be used alone. 1 of 2
For use only after reconstitution
with accompanying Saline
Diluent Component.
Rx only

Haemophilus b Conjugate
Vaccine (Tetanus Toxoid
Conjugate)
ActHIB®

Mfd by: Sanofi Pasteur SA

892140

Lot
EXP

PRINCIPAL DISPLAY PANEL - 0.5 mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 49281-546-58
single-dose (0.6 mL)

Not to be used alone. 2 of 2

Saline Diluent Component
(0.4% Sodium Chloride)

For reconstitution of
ActHIB®
Haemophilus b Conjugate
Vaccine (Tetanus Toxoid
Conjugate)

Rx only

Mfd by: Sanofi Pasteur Inc.
Swiftwater PA 18370 USA

892139

Lot

EXP

PRINCIPAL DISPLAY PANEL - 0.6 mL Vial Label