VAQTA- hepatitis a vaccine, inactivated injection, suspension 
Bamboo US BidCo LLC

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These highlights do not include all the information needed to use VAQTA safely and effectively. See full prescribing information for VAQTA.

VAQTA ®(Hepatitis A Vaccine, Inactivated)
Suspension for Intramuscular Injection
Initial U.S. Approval: 1996

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 Vial Carton

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 - 0.5 mL Syringe Carton

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 Vial Carton

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 Syringe Carton

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

e

VAQTA 
hepatitis a vaccine, inactivated injection, suspension
Product Information
Product TypeVACCINEItem Code (Source)NDC:83703-045
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 NameStrength
SODIUM BORATE (UNII: 91MBZ8H3QO) 35 ug  in 0.5 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (slightly opaque, white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83703-045-0210 in 1 CARTON
1NDC:83703-045-010.5 mL in 1 SYRINGE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10360603/29/1996
VAQTA 
hepatitis a vaccine, inactivated injection, suspension
Product Information
Product TypeVACCINEItem Code (Source)NDC:83703-046
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 NameStrength
SODIUM BORATE (UNII: 91MBZ8H3QO) 70 ug  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (slightly opaque, white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83703-046-0210 in 1 CARTON
1NDC:83703-046-011 mL in 1 SYRINGE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10360603/29/1996
Labeler - Bamboo US BidCo LLC (119087615)

Revised: 6/2024
Document Id: 1b18e6d5-d69d-71e6-e063-6294a90a1e5a
Set id: 1a8b7b47-d5f8-e6b5-e063-6394a90a9ac4
Version: 2
Effective Time: 20240617
 
Bamboo US BidCo LLC