Vaccine Information: VARIVAX (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 10 Single Dose 0.5 mL Vial Carton

10 Single-dose 0.5-mL Vials
NDC 0006-4827-00

VARICELLA VIRUS VACCINE LIVE
VARIVAX®

STORE FROZEN

Oka/Merck Strain. Human cell tissue culture
origin containing trace quantities of neomycin.Contains no preservatives.

Rx only

A

PRINCIPAL DISPLAY PANEL -- 10 Single Dose 0.5 mL Vial Carton
(click image for full-size original)
VARIVAX varicella virus vaccine live injection, powder, lyophilized, for suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4826
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 1350 [PFU] in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
EDETIC ACID
ALBUMIN BOVINE
GELATIN, UNSPECIFIED 12.5 mg in 0.5 mL
MONOSODIUM GLUTAMATE 0.5 mg in 0.5 mL
NEOMYCIN
POTASSIUM CHLORIDE 0.08 mg in 0.5 mL
POTASSIUM PHOSPHATE, MONOBASIC 0.08 mg in 0.5 mL
SODIUM CHLORIDE 3.2 mg in 0.5 mL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 0.45 mg in 0.5 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
SUCROSE 25 mg in 0.5 mL
Product Characteristics
Color YELLOW (clear, colorless to pale yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-4826-00 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0006-4826-01)
1 NDC:0006-4826-01 0.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0006-4826-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103552 03/17/1995
VARIVAX varicella virus vaccine live injection, powder, lyophilized, for suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4827
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 1350 [PFU] in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
EDETIC ACID
ALBUMIN BOVINE
GELATIN, UNSPECIFIED 12.5 mg in 0.5 mL
MONOSODIUM GLUTAMATE 0.5 mg in 0.5 mL
NEOMYCIN
POTASSIUM CHLORIDE 0.08 mg in 0.5 mL
POTASSIUM PHOSPHATE, MONOBASIC 0.08 mg in 0.5 mL
SODIUM CHLORIDE 3.2 mg in 0.5 mL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 0.45 mg in 0.5 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
SUCROSE 25 mg in 0.5 mL
Product Characteristics
Color YELLOW (clear, colorless to pale yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-4827-00 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0006-4827-01)
1 NDC:0006-4827-01 0.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0006-4827-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103552 03/17/1995
Labeler — Merck Sharp & Dohme Corp. (001317601)
Establishment
Name Address ID/FEI Operations
Merck Sharp & Dohme Corp. 002387926 API MANUFACTURE (0006-4826), API MANUFACTURE (0006-4827), MANUFACTURE (0006-4826), MANUFACTURE (0006-4827), ANALYSIS (0006-4826), ANALYSIS (0006-4827), PACK (0006-4826), PACK (0006-4827)
Establishment
Name Address ID/FEI Operations
Merck Sharp & Dohme Corp. 621573075 MANUFACTURE (0006-4826), MANUFACTURE (0006-4827), API MANUFACTURE (0006-4826), API MANUFACTURE (0006-4827), ANALYSIS (0006-4826), ANALYSIS (0006-4827)
Establishment
Name Address ID/FEI Operations
Merck Sharp & Dohme Corp. 101740835 PACK (0006-4826), PACK (0006-4827)

Revised: 09/2020 Merck Sharp & Dohme Corp.

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