NDC Code(s) : 0006-4999-01, 0006-4999-00
Packager : Merck Sharp & Dohme Corp.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ProQuadMeasles, Mumps, Rubella and Varicella Virus Vaccine Live INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-4999
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN(UNII: MFZ8I7277D)
(MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN - UNII:MFZ8I7277D) 		MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN1000 [TCID_50] in 0.5 mL
MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN(UNII: 47QB6MX9KU)
(MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN - UNII:47QB6MX9KU) 		MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN20000 [TCID_50] in 0.5 mL
RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN(UNII: 52202H034Z)
(RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN - UNII:52202H034Z) 		RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN1000 [TCID_50] in 0.5 mL
VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN(UNII: GPV39ZGD8C)
(VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN - UNII:GPV39ZGD8C) 		VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN9772 [PFU] in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
ALBUMIN HUMAN(UNII: ZIF514RVZR)0.31 mg in 0.5 mL
ALBUMIN BOVINE(UNII: 27432CM55Q)0.5 ug in 0.5 mL
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)11 mg in 0.5 mL
MONOSODIUM GLUTAMATE(UNII: W81N5U6R6U)0.4 mg in 0.5 mL
NEOMYCIN(UNII: I16QD7X297)16 ug in 0.5 mL
POTASSIUM CHLORIDE(UNII: 660YQ98I10)60 ug in 0.5 mL
DIBASIC POTASSIUM PHOSPHATE(UNII: CI71S98N1Z)36 ug in 0.5 mL
POTASSIUM PHOSPHATE, MONOBASIC(UNII: 4J9FJ0HL51)72 ug in 0.5 mL
SODIUM BICARBONATE(UNII: 8MDF5V39QO)0.17 mg in 0.5 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)2.4 mg in 0.5 mL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(UNII: GR686LBA74)0.34 mg in 0.5 mL
SORBITOL(UNII: 506T60A25R)1.8 mg in 0.5 mL
SUCROSE(UNII: C151H8M554)21 mg in 0.5 mL
Product Characteristics
Color YELLOW, PINK (clear pale yellow to light pink) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0006-4999-0010 in 1 CARTON
1NDC:0006-4999-010.5 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125108 09/06/2005

PRINCIPAL DISPLAY PANEL

NDC 0006-4999-00
10 Single-dose 0.5-mL Vials

A

Measles, Mumps, Rubella and Varicella
Virus Vaccine Live
ProQuad®

STORE FROZEN

Measles vaccine: More attenuated Enders' Edmonston strain. Chick cell tissue culture origin.
Mumps vaccine: Jeryl Lynn™ strain. Chick cell tissue culture origin.
Rubella vaccine: Wistar RA 27/3 strain. Human diploid cell (WI-38) culture origin.
Varicella vaccine: Oka/Merck strain. Human diploid cell (MRC-5) culture origin.

Contains no preservative. Contains trace quantities of neomycin.

Rx only

Principal Display Panel - 0.5 mL Vial Carton