HEPLISAV-B- hepatitis b vaccine (recombinant) adjuvanted injection, solution 
Bamboo US BidCo LLC

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These highlights do not include all the information needed to use HEPLISAV-B ®safely and effectively. See full prescribing information for HEPLISAV-B.

HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] Solution for Intramuscular Injection
Initial U.S. Approval: 2017

Principal Panel - Carton - Vials

Rx only

Hepatitis B Vaccine
(Recombinant),
Adjuvanted

HEPLISAV-B ™

5 x 0.5 mL
single-dose vials

For intramuscular
administration only

DYNAVAX

Image of Carton of Vials- Principal Panel

Principal Panel - Carton - Prefilled Syringes

Rx only

Hepatitis B Vaccine
(Recombinant),
Adjuvanted

HEPLISAV-B ®

5 x 0.5 mL single-dose syringes

For intramuscular
administration only

For Adult Use Only

NEEDLES NOT INCLUDED

DYNAVAX

Image of Carton of Syringes- Principal Panel

Principal Panel - Label - Prefilled Syringes

HEPLISAV-B ®

1 dose (0.5 mL)

Hepatitis B Vaccine
(Recombinant), Adjuvanted

For IM use only DO NOT FREEZE
Store at 2-8°C (36-46°F)
Mfd. by Dynavax Tech. Corp.

Image of Label for PRefilled Syringes - Principal Panel
HEPLISAV-B 
hepatitis b vaccine (recombinant) adjuvanted injection, solution
Product Information
Product TypeVACCINEItem Code (Source)NDC:83703-048
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 ANTIGEN20 ug  in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
1018 ISS (UNII: 25DT549L0G)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO)  
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83703-048-055 in 1 CARTON
1NDC:83703-048-010.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA12542801/01/2018
Labeler - Bamboo US BidCo LLC (119087615)
Registrant - Dynavax Technologies Corporation (964173801)

Revised: 6/2024
Document Id: 1b18ff1d-56a7-e7ae-e063-6294a90ad2d0
Set id: 1a8b8271-208d-ecde-e063-6294a90a54c6
Version: 2
Effective Time: 20240617
 
Bamboo US BidCo LLC