VAQTA- hepatitis a vaccine, inactivated injection, suspension

VAQTA by

Drug Labeling and Warnings

VAQTA 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 - 0.5 mL Vials Carton

10 Single-dose ~25U/0.5-mL Vials

(HEPATITIS A VACCINE, INACTIVATED)
VAQTA ®
PEDIATRIC/ADOLESCENT

0.5 mL vial contains approximately 25U of hepatitis A virus antigen on an Amorphous aluminum
hydroxyphosphate sulfate adjuvant. Hepatitis A virus is grown in cell culture in human MRC-5
diploid fibroblasts.

Rx only

PRINCIPAL DISPLAY PANEL - 0.5 mL Syringes Carton

10 Single-Dose 0.5-mL Syringes

[HEPATITIS A VACCINE,
INACTIVATED]
VAQTA ®

PEDIATRIC/ADOLESCENT
FORMULATION

This package contains 10 single-dose syringes.
Each 0.5-mL syringe contains approximately 25U of hepatitis A virus antigen
on an amorphous aluminum hydroxyphosphate sulfate adjuvant.

Hepatitis A virus is grown in cell culture in human MRC-5 diploid fibroblasts.

Rx only

PRINCIPAL DISPLAY PANEL - 1 mL Vials Carton

10 Single-dose
~50U/1-mL Vials

(HEPATITIS A VACCINE, INACTIVATED)
VAQTA ®
ADULT FORMULATION

1 mL vial contains approximately 50U of hepatitis A virus antigen on an Amorphous aluminum
hydroxyphosphate sulfate adjuvant. Hepatitis A virus is grown in cell culture in human MRC-5
diploid fibroblasts.

Rx only

PRINCIPAL DISPLAY PANEL - 1 mL Syringes Carton

10 Single-Dose 1-mL Syringes

[HEPATITIS A VACCINE,
INACTIVATED]
VAQTA ®

ADULT FORMULATION

This package contains 10 single-dose syringes.
Each 1-mL syringe contains approximately 50U of hepatitis A virus antigen
on an amorphous aluminum hydroxyphosphate sulfate adjuvant.

Hepatitis A virus is grown in cell culture in human MRC-5 diploid fibroblasts.

Rx only

PRINCIPAL DISPLAY PANEL - 1 mL Vial Carton

1 Single-dose
~50U/1-mL Vial

(HEPATITIS A
VACCINE,
INACTIVATED)
VAQTA ®

ADULT
FORMULATION

1 mL contains approximately 50U
of hepatitis A virus antigen on an
Amorphous aluminum hydroxyphos-
phate sulfate adjuvant.

Hepatitis A virus is grown in cell
culture in human MRC-5 diploid
fibroblasts.

Rx only

INGREDIENTS AND APPEARANCE

VAQTA 
hepatitis a vaccine, inactivated injection, suspension

Product Information
Product Type	VACCINE	Item Code (Source)	NDC: 83703-045
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: Q04Q922K9Q) (HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:Q04Q922K9Q)	HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED)	25 [iU]  in 0.5 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BORATE (UNII: 91MBZ8H3QO)	35 ug  in 0.5 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (slightly opaque, white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83703-045-02	10 in 1 CARTON
1	NDC: 83703-045-01	0.5 mL in 1 SYRINGE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103606	03/29/1996

VAQTA 
hepatitis a vaccine, inactivated injection, suspension

Product Information
Product Type	VACCINE	Item Code (Source)	NDC: 83703-046
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: Q04Q922K9Q) (HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:Q04Q922K9Q)	HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED)	50 [iU]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BORATE (UNII: 91MBZ8H3QO)	70 ug  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (slightly opaque, white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83703-046-02	10 in 1 CARTON
1	NDC: 83703-046-01	1 mL in 1 SYRINGE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103606	03/29/1996

Labeler - Bamboo US BidCo LLC (119087615)