Vaccine Information: RECOMBIVAX HB (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 1.0 mL Syringe Carton

NDC 0006-4094-02
10 Single-Dose 1.0-mL Syringes

HEPATITIS B VACCINE
[RECOMBINANT]
RECOMBIVAX HB®

ADULT FORMULATION

Preservative Free

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 cerevisiae containing the gene for the adw subtype of HBsAg.

This Product Contains No Thimerosal. Rx only

PRINCIPAL DISPLAY PANEL -- 1.0 mL Syringe Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1 mL Vial Carton — 4992

NDC 0006-4992-00
1 Single-dose
40 mcg/1 mL Vial

HEPATITIS B
VACCINE
[RECOMBINANT]
RECOMBIVAX HB®

DIALYSIS
FORMULATION

Preservative Free

1 mL contains 40 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 cerevisiae
containing the gene for the adw subtype of HBsAg.

This Product Contains No Thimerosal.

Rx only

PRINCIPAL DISPLAY PANEL -- 1 mL Vial Carton -- 4992
(click image for full-size original)
RECOMBIVAX HB hepatitis b vaccine (recombinant) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4981
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN (HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN) 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 Multilevel Packaging
1 NDC:0006-4981-00 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0006-4981-01)
1 NDC:0006-4981-01 0.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0006-4981-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101066 07/23/1986
RECOMBIVAX HB hepatitis b vaccine (recombinant) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4093
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN (HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN) 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 Multilevel Packaging
1 NDC:0006-4093-09 6 SYRINGE in 1 CARTON contains a SYRINGE (0006-4093-01)
1 NDC:0006-4093-01 0.5 mL in 1 SYRINGE This package is contained within the CARTON (0006-4093-09)
2 NDC:0006-4093-02 10 SYRINGE in 1 CARTON contains a SYRINGE (0006-4093-01)
2 NDC:0006-4093-01 0.5 mL in 1 SYRINGE This package is contained within the CARTON (0006-4093-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101066 07/23/1986
RECOMBIVAX HB hepatitis b vaccine (recombinant) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4995
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN (HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN) 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 Multilevel Packaging
1 NDC:0006-4995-41 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0006-4995-01)
1 NDC:0006-4995-01 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0006-4995-41)
2 NDC:0006-4995-00 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0006-4995-01)
2 NDC:0006-4995-01 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0006-4995-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101066 07/23/1986
RECOMBIVAX HB hepatitis b vaccine (recombinant) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4094
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN (HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN) 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 Multilevel Packaging
1 NDC:0006-4094-09 6 SYRINGE in 1 CARTON contains a SYRINGE (0006-4094-01)
1 NDC:0006-4094-01 1 mL in 1 SYRINGE This package is contained within the CARTON (0006-4094-09)
2 NDC:0006-4094-02 10 SYRINGE in 1 CARTON contains a SYRINGE (0006-4094-01)
2 NDC:0006-4094-01 1 mL in 1 SYRINGE This package is contained within the CARTON (0006-4094-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101066 07/23/1986
RECOMBIVAX HB hepatitis b vaccine (recombinant) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4992
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN (HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN) HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 40 ug in 1 mL
Product Characteristics
Color WHITE (slightly opaque, white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-4992-00 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0006-4992-01)
1 NDC:0006-4992-01 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0006-4992-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101066 07/23/1986
Labeler — Merck Sharp & Dohme Corp. (001317601)
Establishment
Name Address ID/FEI Operations
Merck Sharp & Dohme Corp. 002387926 API MANUFACTURE, MANUFACTURE, PACK
Establishment
Name Address ID/FEI Operations
Merck Sharp & Dohme Corp. 101740835 PACK

Revised: 02/2020 Merck Sharp & Dohme Corp.

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