RECOMBIVAX HB (hepatitis b vaccine- recombinant injection, suspension

Drug Labeling and Warnings

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Carton

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 - 1.0 mL Syringe Carton

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

INGREDIENTS AND APPEARANCE

RECOMBIVAX HB 
hepatitis b vaccine (recombinant) injection, suspension

Product Information
Product Type	VACCINE	Item Code (Source)	NDC: 83703-085
Route of Administration	SUBCUTANEOUS, INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN (UNII: XL4HLC6JH6) (HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN - UNII:XL4HLC6JH6)	HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN	5 ug  in 0.5 mL

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: 83703-085-02	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	BLA101066	02/26/2026

RECOMBIVAX HB 
hepatitis b vaccine (recombinant) injection, suspension

Product Information
Product Type	VACCINE	Item Code (Source)	NDC: 83703-086
Route of Administration	SUBCUTANEOUS, INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN (UNII: XL4HLC6JH6) (HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN - UNII:XL4HLC6JH6)	HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN	10 ug  in 1 mL

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: 83703-086-02	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	BLA101066	02/26/2026

Labeler - Bamboo US BidCo LLC (119087615)