Vaccine Information: RabAvert (Page 4 of 4)

Rabies Vaccine

Label ImageLabel Image
RABAVERT
rabies vaccine kit
Product Information
Product Type VACCINE Item Code (Source) NDC:50090-3096(NDC:58160-964)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-3096-0 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, GLASS 1 mL
Part 2 1 SYRINGE 1 mL
Part 1 of 2
RABAVERT
rabies vaccine powder, for suspension
Product Information
Item Code (Source) NDC:58160-966
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RABIES VIRUS STRAIN FLURY LEP ANTIGEN (PROPIOLACTONE INACTIVATED) (RABIES VIRUS STRAIN FLURY LEP ANTIGEN (PROPIOLACTONE INACTIVATED)) RABIES VIRUS STRAIN FLURY LEP ANTIGEN (PROPIOLACTONE INACTIVATED) 2.5 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
Tromethamine
Sodium chloride
EDETATE DISODIUM
POTASSIUM GLUCONATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-966-01 1 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103334 12/19/2016
Part 2 of 2
STERILE DILUENT
sterile diluent injection
Product Information
Item Code (Source) NDC:58160-967
Route of Administration INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-967-02 1 mL in 1 SYRINGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103334 12/19/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103334 12/19/2016
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-3096)

Revised: 01/2020 A-S Medication Solutions

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