Vaccine Information: PedvaxHIB (Page 4 of 4)

This is a representative sample of the packaging. Please see How Supplied section for a complete list of available packaging.

PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Carton

NDC 0006-4897-00
10 Single-dose
0.5 mL Vials Vaccine

HAEMOPHILUS b CONJUGATE VACCINE
(Meningococcal Protein Conjugate)
Liquid PedvaxHIB®

Each 0.5 mL of vaccine is formulated to contain: 7.5 mcg of Haemophilus influenzae type b
polysaccharide, 125 mcg of Neisseria meningitidis outer membrane protein complex, 225 mcg of amorphous aluminum hydroxyphosphate sulfate in 0.9% sodium chloride.

Rx only

PRINCIPAL DISPLAY PANEL -- 0.5 mL Vial Carton
(click image for full-size original)
PEDVAXHIB haemophilus b conjugate vaccine (meningococcal protein conjugate) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4897
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN (HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN) HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN 7.5 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
Product Characteristics
Color WHITE (slightly opaque white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-4897-00 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0006-4897-01)
1 NDC:0006-4897-01 0.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0006-4897-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103237 12/20/1989
Labeler — Merck Sharp & Dohme Corp. (001317601)
Establishment
Name Address ID/FEI Operations
Merck Sharp & Dohme Corp. 002387926 API MANUFACTURE, MANUFACTURE
Establishment
Name Address ID/FEI Operations
Merck Sharp & Dohme Corp. 101740835 PACK

Revised: 02/2020 Merck Sharp & Dohme Corp.

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