RECOMBIVAX HB

Product NDC: 50090-1716
11-digit product format: 500901716
Labeler code: 50090
Product ID: 50090-1716_3b141f8c-3380-4cf3-b764-29b06e7f3f66
Type: VACCINE
Nonproprietary name: Hepatitis B Vaccine (Recombinant)
Dosage form: INJECTION, SUSPENSION
Route: INTRAMUSCULAR; SUBCUTANEOUS
Labeler: A-S Medication Solutions
Application: BLA101066
Marketing category: BLA
Marketing start: 1986-07-23
Marketing end: 0000-00-00
Substance: HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN
Active strength: 5 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: 2022-12-31
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	50090-1716		I	Inactivated by FDA		2026-08-17
excluded package	package	50090-1716	50090-1716-0	I	Inactivated by FDA		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 · 30 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	50090-1716-0	`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	50090-1716-0	`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	50090-1716-0	`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	50090-1716-0	`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	50090-1716-0	`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	50090-1716-0	`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	50090-1716-0	`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	50090-1716-0	`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	50090-1716-0	`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	50090-1716-0	`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	50090-1716-0	`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	50090-1716-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-1716-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-1716-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-1716-0	`1332a3947898…`	`d4bfe170f9cd…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-1716-0	2023-01-30	C162847	48780-1	f386c649-c316-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use RECOMBIVAX HB safely and effectively. See full prescribing information for RECOMBIVAX HB. RECOMBIVAX HB® Hepatitis B Vaccine (Recombinant) Suspension for intramuscular injection Initial U.S. Approval: 1986

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-1716-0	RECOMBIVAX HB	10 in 1 POUCH	INJECTION, SUSPENSION	10		15
50090-1716-9	RECOMBIVAX HB	.5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SUSPENSION	.5		15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-1716	RECOMBIVAX HB (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]	15	Legacy NDC, 2 package rows	20210617_f1ad4bca-839d-41cd-a132-a6984780912e.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
101066	Recombivax, Recombivax Hb	Hepatitis B Vaccine (Recombinant)	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
1658154	hepatitis B vaccine (recombinant) pediatric/adolescent (HepB) 5 MCG/0.5 ML Injection	PSN	f1ad4bca-839d-41cd-a132-a6984780912e	15
1658155	RECOMBIVAX HB pediatric/adolescent vaccine 0.5 ML Injection	PSN	f1ad4bca-839d-41cd-a132-a6984780912e	15
1658155	0.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Injection [Recombivax]	SBD	f1ad4bca-839d-41cd-a132-a6984780912e	15
1658154	0.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Injection	SCD	f1ad4bca-839d-41cd-a132-a6984780912e	15
1658155	0.5 ML Recombivax 0.01 MG/ML Injection	SY	f1ad4bca-839d-41cd-a132-a6984780912e	15
1658154	hepatitis B surface antigen vaccine 5 MCG per 0.5 ML Injection	SY	f1ad4bca-839d-41cd-a132-a6984780912e	15
1658155	Recombivax HB 5 MCG per 0.5 ML Injection	SY	f1ad4bca-839d-41cd-a132-a6984780912e	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1716-0	50090171600	10 VIAL, SINGLE-DOSE in 1 POUCH (50090-1716-0) > .5 mL in 1 VIAL, SINGLE-DOSE (50090-1716-9)	1986-07-23	0000-00-00	No	No	Current
50090-1716-9	50090171609	.5 mL in 1 VIAL, SINGLE-DOSE					Historical