Heplisav-b Injection, Solution
FDA Label NDC 83703-048

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bamboo Us Bidco Llc for the product Heplisav-b (NDC 83703-048). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Package Label.Principal Display Panel

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 (Heplisav B 01)

Image Of Carton Of Vials- Principal Panel (Heplisav B 01)

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 (Heplisav B 02)

Image Of Carton Of Syringes- Principal Panel (Heplisav B 02)

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)

Image Of Label For Prefilled Syringes (Principal Panel)

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