HEPLISAV-B

Product NDC: 43528-002
11-digit product format: 435280002
Labeler code: 43528
Product ID: 43528-002_cf21c709-2864-4ded-9b5f-b41f1f0f8f0b
Type: VACCINE
Nonproprietary name: Hepatitis B Vaccine (Recombinant) Adjuvanted
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: Dynavax Technologies Corporation
Application: BLA125428
Marketing category: BLA
Marketing start: 2018-01-01
Marketing end: 0000-00-00
Substance: HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN
Active strength: 20 ug/.5mL
Pharmacologic classes: Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [CS],Vaccines, Inactivated [CS]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	43528-002		D	Discontinued by firm		2026-08-17
excluded package	package	43528-002	43528-002-05	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43528-002-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43528-002-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43528-002-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43528-002-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43528-002-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43528-002-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43528-002-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43528-002-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43528-002-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43528-002-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43528-002-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43528-002-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43528-002-01	HEPLISAV-B	0.5 mL in 1 VIAL	INJECTION, SOLUTION	0.5		10
43528-002-05	HEPLISAV-B	5 in 1 CARTON	INJECTION, SOLUTION	5		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43528-002-01	ML - Milliliter	43528-002	67cb7ef6-ac0f-42e4-8cf4-bdf28a0ebad9	1	2018-02-20
43528-002-05	ML - Milliliter	43528-002	607bbbe9-9729-4566-b8d8-50a1a70a27ec	1	2018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43528-002	HEPLISAV-B (HEPATITIS B VACCINE (RECOMBINANT) ADJUVANTED) INJECTION, SOLUTION [DYNAVAX TECHNOLOGIES CORPORATION]	9	Legacy NDC, 2 package rows	20240920_d61c7f99-438b-4cac-ae10-997ff4c0fd1f.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125428	Heplisav-B	Hepatitis B Vaccine (Recombinant), Adjuvanted	351(a)	Rx	2026-08-01

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
XL4HLC6JH6	HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN	HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1994347	hepatitis B surface antigen vaccine 20 MCG in 0.5 ML Injection	PSN	d61c7f99-438b-4cac-ae10-997ff4c0fd1f	10
2050057	hepatitis B surface antigen vaccine 20 MCG in 0.5 ML Prefilled Syringe	PSN	d61c7f99-438b-4cac-ae10-997ff4c0fd1f	10
1994352	HEPLISAV-B 20 MCG in 0.5 ML Injection	PSN	d61c7f99-438b-4cac-ae10-997ff4c0fd1f	10
2050059	HEPLISAV-B 20 MCG in 0.5 ML Prefilled Syringe	PSN	d61c7f99-438b-4cac-ae10-997ff4c0fd1f	10
1994352	0.5 ML hepatitis B surface antigen vaccine 0.04 MG/ML Injection [Heplisav-B]	SBD	d61c7f99-438b-4cac-ae10-997ff4c0fd1f	10
2050059	0.5 ML hepatitis B surface antigen vaccine 0.04 MG/ML Prefilled Syringe [Heplisav-B]	SBD	d61c7f99-438b-4cac-ae10-997ff4c0fd1f	10
1994347	0.5 ML hepatitis B surface antigen vaccine 0.04 MG/ML Injection	SCD	d61c7f99-438b-4cac-ae10-997ff4c0fd1f	10
2050057	0.5 ML hepatitis B surface antigen vaccine 0.04 MG/ML Prefilled Syringe	SCD	d61c7f99-438b-4cac-ae10-997ff4c0fd1f	10
2050059	0.5 ML Heplisav-B 0.04 MG/ML Prefilled Syringe	SY	d61c7f99-438b-4cac-ae10-997ff4c0fd1f	10
1994347	hepatitis B surface antigen vaccine 0.04 MG/ML per 0.5 ML Injection	SY	d61c7f99-438b-4cac-ae10-997ff4c0fd1f	10
2050057	hepatitis B surface antigen vaccine 0.04 MG/ML per 0.5 ML Prefilled Syringe	SY	d61c7f99-438b-4cac-ae10-997ff4c0fd1f	10
1994347	hepatitis B surface antigen vaccine 20 MCG per 0.5 ML Injection	SY	d61c7f99-438b-4cac-ae10-997ff4c0fd1f	10
1994347	hepatitis B vaccine (recombinant) pediatric/adolescent 20 MCG in 0.5 ML Injection	SY	d61c7f99-438b-4cac-ae10-997ff4c0fd1f	10
1994352	Heplisav-B 0.04 MG/ML per 0.5 ML Injection	SY	d61c7f99-438b-4cac-ae10-997ff4c0fd1f	10
2050059	Heplisav-B 0.04 MG/ML per 0.5 ML Prefilled Syringe	SY	d61c7f99-438b-4cac-ae10-997ff4c0fd1f	10
1994352	Heplisav-B 20 MCG per 0.5 ML Injection	SY	d61c7f99-438b-4cac-ae10-997ff4c0fd1f	10
2050059	HEPLISAV-B 20 MCG per 0.5 ML Prefilled Syringe	SY	d61c7f99-438b-4cac-ae10-997ff4c0fd1f	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
43528-002-01	43528000201	0.5 mL in 1 VIAL	0.5 ml	Historical
43528-002-05	43528000205	5 in 1 CARTON		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HEPLISAV-B	Dynavax Technologies Corporation \| Rhein Biotech GmbH	2026-02-19	VACCINE LABEL	10
HEPLISAV-B	A-S Medication Solutions	2018-06-06	VACCINE LABEL	11