Label: RECOMBIVAX HB (hepatitis b vaccine- recombinant injection, suspension
- NDC Code(s): 83703-085-02, 83703-086-02
- Packager: Bamboo US BidCo LLC
- Category: VACCINE LABEL
- DEA Schedule: None
- Marketing Status: Biologic Licensing Application
Drug Label Information
Updated March 5, 2026
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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, suspensionProduct 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, suspensionProduct 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)