FDA.reportPublic FDA data

RECOMBIVAX HB® Hepatitis B Vaccine (Recombinant)

Manufacturer
Bamboo US BidCo LLC
Effective date
2026-03-05
Label type
VACCINE LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:52:57

Label at a glance#

ProductRECOMBIVAX HB
Active ingredientHEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN
Label structure2 sections

Label contents#

Full prescribing information#

PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10 Single-Dose 0.5-mL Syringes

HEPATITIS B VACCINE
[RECOMBINANT]
RECOMBIVAX HB ®

PEDIATRIC/ADOLESCENT FORMULATION

No Preservative

This package contains 10 single-dose syringes. Each 0.5-mL syringe contains
5 mcg of hepatitis B surface antigen adjuvanted with amorphous aluminum
hydroxyphosphate sulfate.

Vaccine is prepared from fermentation cultures of a recombinant strain of the yeast
Saccharomyces cerevisiaecontaining the gene for the adwsubtype of HBsAg.

This Product Contains No Thimerosal.
Rx only

PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe CartonPRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Carton

PRINCIPAL DISPLAY PANEL - 1.0 mL Syringe Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10 Single-Dose 1.0-mL Syringes

HEPATITIS B VACCINE
[RECOMBINANT]
RECOMBIVAX HB ®

ADULT FORMULATION

No Preservative

This package contains 10 single-dose syringes. Each 1.0-mL syringe contains
10 mcg of hepatitis B surface antigen adjuvanted with amorphous aluminum
hydroxyphosphate sulfate.

Vaccine is prepared from fermentation cultures of a recombinant strain of the yeast
Saccharomyces cerevisiaecontaining the gene for the adwsubtype of HBsAg.

This Product Contains No Thimerosal.
Rx only

PRINCIPAL DISPLAY PANEL - 1.0 mL Syringe CartonPRINCIPAL DISPLAY PANEL - 1.0 mL Syringe Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
830243hepatitis B vaccine (recombinant) adult (HepB) 10 MCG in 1 ML Prefilled SyringePSN1
830252hepatitis B vaccine (recombinant) pediatric/adolescent (HepB) 5 MCG/0.5 ML Prefilled SyringePSN1
830245RECOMBIVAX HB adult vaccine 1 ML Prefilled SyringePSN1
830253RECOMBIVAX HB pediatric/adolescent vaccine 0.5 ML Prefilled SyringePSN1
8302530.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Prefilled Syringe [Recombivax]SBD1
8302451 ML hepatitis B surface antigen vaccine 0.01 MG/ML Prefilled Syringe [Recombivax]SBD1
8302520.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Prefilled SyringeSCD1
8302431 ML hepatitis B surface antigen vaccine 0.01 MG/ML Prefilled SyringeSCD1
8302530.5 ML Recombivax HB Pediatric/Adolescent 10 MCG/ML Prefilled SyringeSY1
8302530.5 ML Recombivax HB, hepatitis B vaccine (recombinant) Prefilled SyringeSY1
8302451 ML Recombivax HB, Hepatitis B vaccine (recombinant) adult formulation Prefilled SyringeSY1
830252hepatitis B surface antigen vaccine 0.005 MG per 0.5 ML Prefilled SyringeSY1
830243hepatitis B surface antigen vaccine 0.01 MG per 1 ML Prefilled SyringeSY1
830243hepatitis B surface antigen vaccine 10 MCG per 1 ML Prefilled SyringeSY1
830252hepatitis B surface antigen vaccine 5 MCG per 0.5 ML Prefilled SyringeSY1
830253Recombivax HB 5 MCG per 0.5 ML Prefilled SyringeSY1
830245Recombivax HB, Hepatitis B vaccine (recombinant) adult formulation 10 MCG per 1 ML Prefilled SyringeSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83703-085-02RECOMBIVAX HB0.5 mL in 1 SYRINGEINJECTION, SUSPENSION0.51
83703-086-02RECOMBIVAX HB1 mL in 1 SYRINGEINJECTION, SUSPENSION11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83703-08583703-085-02
83703-08683703-086-02

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
101066Recombivax, Recombivax HbHepatitis B Vaccine (Recombinant)351(a)Rx2026-09-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGENXL4HLC6JH6ACTIB
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGENXL4HLC6JH6ACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.