Vaccine Information: ZOSTAVAX (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 0.65 mL Vial Carton

A

NDC 0006-4963-00
1 Single-dose Vial (0.65 mL)

Zoster Vaccine Live
ZOSTAVAX®

STORE FROZEN

Oka/Merck strain. Human
diploid cell (MRC-5) culture
origin. Each 0.65-mL
dose contains a
minimum of 19,400 PFU
(plaque-forming units).

Contains no preservative.
Contains trace quantitiesof neomycin.

Rx only

PRINCIPAL DISPLAY PANEL -- 0.65 mL Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.7 mL Vial Carton

NDC 0006-4309-00

10 Single-Dose
0.7-mL Vials

STERILE DILUENT

FOR MERCK SHARP & DOHME CORP.
LIVE VIRUS VACCINES
(Sterile Water)

Rx only
B

CONTAINS NO PRESERVATIVE

This carton contains 10 diluent-containing vials. Use one diluent vialfor reconstitution of one single-dose vial of live virus vaccine.

PRINCIPAL DISPLAY PANEL -- 0.7 mL Vial Carton
(click image for full-size original)
ZOSTAVAX zoster vaccine live injection, powder, lyophilized, for suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4963
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN (VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN) VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN 19400 [PFU] in 0.65 mL
Inactive Ingredients
Ingredient Name Strength
ALBUMIN BOVINE
GELATIN, UNSPECIFIED 15.58 mg in 0.65 mL
MONOSODIUM GLUTAMATE 0.62 mg in 0.65 mL
POTASSIUM CHLORIDE 0.1 mg in 0.65 mL
POTASSIUM PHOSPHATE, MONOBASIC 0.1 mg in 0.65 mL
SODIUM CHLORIDE 3.99 mg in 0.65 mL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 0.57 mg in 0.65 mL
SUCROSE 31.16 mg in 0.65 mL
NEOMYCIN
Product Characteristics
Color WHITE, YELLOW (off-white to pale yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-4963-00 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0006-4963-01)
1 NDC:0006-4963-01 0.65 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0006-4963-00)
2 NDC:0006-4963-41 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0006-4963-01)
2 NDC:0006-4963-01 0.65 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0006-4963-41)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125123 05/25/2006
STERILE DILUENT sterile water injection
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4309
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 0.7 mL in 0.7 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-4309-00 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0006-4309-01)
1 NDC:0006-4309-01 0.7 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0006-4309-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125123 05/25/2006
Labeler — Merck Sharp & Dohme Corp. (001317601)

Revised: 12/2020 Merck Sharp & Dohme Corp.

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