Label: VAQTA- hepatitis a vaccine, inactivated injection, suspension

  • NDC Code(s): 83703-045-01, 83703-045-02, 83703-046-01, 83703-046-02
  • Packager: Bamboo US BidCo LLC
  • Category: VACCINE LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated June 17, 2024

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  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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