FDA.reportPublic FDA data

These highlights do not include all the information needed to use HEPLISAV-B

Manufacturer
Bamboo US BidCo LLC | Dynavax Technologies Corporation
Effective date
2026-06-10
Label type
VACCINE LABEL
Version
6
Source
daily-update
Hydrated at
2026-06-12 05:10:18

Label at a glance#

ProductHEPLISAV-B
Active ingredientHEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN
Label structure2 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY 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

[[

PACKAGE LABEL.PRINCIPAL DISPLAY 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.

349349

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00343528003017(17)000100(10)XXXXXXGTIN-14: 00343528003017
GTIN-12: 343528003017
UPC-A: 343528003017
EAN-13: 0343528003017
GTIN storage (14 digits): 00343528003017		349.jpg
BarcodeDataBar Limited(01)00343528003017GTIN-14: 00343528003017
GTIN-12: 343528003017
UPC-A: 343528003017
EAN-13: 0343528003017
GTIN storage (14 digits): 00343528003017		349.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83703-04883703-048-01, 83703-048-05

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125428Heplisav-BHepatitis B Vaccine (Recombinant), Adjuvanted351(a)Rx2026-09-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XIACT
1018 ISS25DT549L0GIACT
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATEE1W4N241FOIACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956IACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGENXL4HLC6JH6ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52026-02-02full-release2026-06-01 02:52:57

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 9 · 174 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nacl 0.9% Normal Saline SolutionSODIUM CHLORIDECHI FUNG TECHNOLOGY COMPANY5a53c4c8-c9de-700c-e063-6394a90a3ab52026-08-31WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEYYBA CORP597f3347-647c-3545-e063-6294a90abab22026-08-20WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e882026-08-20Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Hypertonic SalineSODIUM CHLORIDENAVEH PHARMA (1996) LTD167c7a9c-1228-4fb2-a89c-d3e1483863232026-07-30WarningsName fallback
generic name: SODIUM CHLORIDE
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
WHWSWB 0.9% SalineSODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd4e9c21e5-f2f9-90e4-e063-6394a90acfe22026-07-11WarningsName fallback
generic name: SODIUM CHLORIDE
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsName fallback
generic name: SODIUM CHLORIDE
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsName fallback
generic name: SODIUM CHLORIDE
0.9% Sodium Chloride Saline SolutionSODIUM CHLORIDEYunqi Cosmetics (Shenzhen) Co., Ltd546af257-dbd1-11fc-e063-6394a90a8e0a2026-06-16WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDECardinal Health 107, LLC107af8bc-b6af-4b85-8c8a-ea757dcef1da2026-06-12Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
SALINE CLEANINGSODIUM CHLORIDEGuangzhou Huanmei Cosmetics Co., Ltd.524f07cc-ddb9-dda5-e063-6394a90ac0a52026-05-21WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.a2a964f7-c3ec-4dfb-e3a0-6d8136a803972026-05-19Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDESportpharm LLCa2c111f6-74d5-4a5d-82ac-d0f237488cb82026-04-24Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsName fallback
generic name: SODIUM CHLORIDE
SODIUM CHLORIDE 1 GRAMSODIUM CHLORIDEGendose Pharmaceuticals, LLCce988ae5-61c6-4324-90e1-a94c8a54d0d02026-04-13WarningsName fallback
generic name: SODIUM CHLORIDE
Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEWalgreen Companybda3b9db-5fc4-408c-a5ae-d1eeb3ee308d2026-04-06WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEHanlim4ee80e16-1bb1-8238-e063-6294a90aa7192026-04-04WarningsName fallback
generic name: SODIUM CHLORIDE

Reported adverse events (FAERS/openFDA)#

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