STERILE DILUENT FOR M-M-R II- measles, mumps, and rubella virus vaccine live injection, powder, lyophilized, for suspension

Sterile Diluent for M-M-R II by

Drug Labeling and Warnings

Sterile Diluent for M-M-R II by is a Other medication manufactured, distributed, or labeled by Bamboo US BidCo LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL - 0.7 mL Syringe

10 Single-Dose 0.7-mL Syringes

STERILE DILUENT

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

CONTAINS NO PRESERVATIVE

This carton contains 10 prefilled syringes. Each prefilled syringe
contains 0.7 mL of sterile diluent. Use one prefilled syringe for
reconstitution of one single-dose vial of live virus vaccine.

Rx only

PRINCIPAL DISPLAY PANEL - 0.7 mL Syringe

CONTAINS NO PRESERVATIVE

1 Single-Dose 0.7-mL
Syringe

STERILE DILUENT

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

Rx only

Manufactured for:
Merck Sharp & Dohme LLC
By: Baxter Pharmaceutical Solutions, LLC

INGREDIENTS AND APPEARANCE

STERILE DILUENT FOR M-M-R II 
measles, mumps, and rubella virus vaccine live injection, powder, lyophilized, for suspension

Product Information
Product Type	VACCINE	Item Code (Source)	NDC: 83703-049
Route of Administration	SUBCUTANEOUS

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 ANTIGEN	1000 [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 ANTIGEN	12500 [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 ANTIGEN	1000 [TCID_50]  in 0.5 mL

Inactive Ingredients
Ingredient Name	Strength
ALBUMIN BOVINE (UNII: 27432CM55Q)
ALBUMIN HUMAN (UNII: ZIF514RVZR)	0.3 mg  in 0.5 mL
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)	14.5 mg  in 0.5 mL
NEOMYCIN (UNII: I16QD7X297)	25 ug  in 0.5 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SORBITOL (UNII: 506T60A25R)	14.5 mg  in 0.5 mL
SUCROSE (UNII: C151H8M554)	1.9 mg  in 0.5 mL

Product Characteristics
Color	yellow (clear yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83703-049-89	0.7 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA101069	04/21/1971

Labeler - Bamboo US BidCo LLC (119087615)