Vaccine Information: RabAvert (Page 4 of 4)

Principal Display Panel — Carton Label

Principal Display Panel -- Carton Label
(click image for full-size original)

Carton Label

NDC 50632-010-01 Rx only

Rabies Vaccine RABAVERT

BAVARIAN NORDIC

Indicated for All Age Groups

Single-dose freeze dried vaccinePre- and post-exposure intramuscular immunization only

Principal Display Panel — Vial Label

Principal Display Panel -- Vial Label
(click image for full-size original)

Vial Label

Rabies Vaccine
RABAVERT
NDC50632-013-01

Single-Dose Vial
Potency ≥ 2.5 IU/mL
Mfd. for Bavarian Nordic A/S by GSK Vaccines, GmbH

Principal Display Panel — Diluent Label

Principal Display Panel -- Diluent Label
(click image for full-size original)

Pre-Filled Syringe of Sterile Diluent Label

NDC 50632-011-01

Sterile
Diluent for
RABAVERT

1 mL

Lot:
Exp:

Mfd. for Bavarian Nordic A/S byVetter Pharma International GmbH

RABAVERT rabies vaccine kit
Product Information
Product Type VACCINE Item Code (Source) NDC:50632-010
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50632-010-01 1 KIT in 1 CARTON 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:50632-013
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:50632-013-01 1 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103334 11/11/1997
Part 2 of 2
STERILE DILUENT sterile diluent injection
Product Information
Item Code (Source) NDC:50632-011
Route of Administration INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50632-011-01 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 11/11/1997
Labeler — Bavarian Nordic A/S (310209754)

Revised: 04/2021 Bavarian Nordic A/S

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