ENGERIX-B

Product NDC: 58160-821
11-digit product format: 581600821
Labeler code: 58160
Product ID: 58160-821_6aa9718e-caf6-4427-8051-f2e5438a0386
Type: VACCINE
Nonproprietary name: Hepatitis B Vaccine (Recombinant)
Dosage form: INJECTION, SUSPENSION
Route: INTRAMUSCULAR
Labeler: GlaxoSmithKline Biologicals SA
Application: BLA103239
Marketing category: BLA
Marketing start: 2007-03-28
Substance: HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN
Active strength: 20 ug/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: ENGERIX-B
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN	20 ug/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58160-821-01	ENGERIX-B	1 mL in 1 VIAL	INJECTION, SUSPENSION	1	34
58160-821-11	ENGERIX-B	10 in 1 CARTON	INJECTION, SUSPENSION	10	34
58160-821-43	ENGERIX-B	1 mL in 1 SYRINGE	INJECTION, SUSPENSION	1	34
58160-821-52	ENGERIX-B	10 in 1 CARTON	INJECTION, SUSPENSION	10	34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58160-821-01	ML - Milliliter	58160-821	485a79a7-4b7a-4c24-8c22-1bf4e84b9f7a	1	2015-07-20
58160-821-05	ML - Milliliter	58160-821	b49156d2-e200-49b5-ae4f-c28d3593c605	1	2022-06-06
58160-821-11	ML - Milliliter	58160-821	d495ee97-416a-4578-bfec-11ff818b018e	1	2013-02-13
58160-821-32	ML - Milliliter	58160-821	89ab0d6c-3a97-4601-9fac-020cb36bf3f9	1	2013-02-13
58160-821-34	ML - Milliliter	58160-821	f27d8948-245a-4be8-a1d1-bf6b3a7e46df	1	2019-03-12
58160-821-43	ML - Milliliter	58160-821	ebf44ab7-fc20-4f98-9994-c75554d020ed	1	2013-03-03
58160-821-52	ML - Milliliter	58160-821	9719ff3c-76af-4177-8ba5-68348179ad81	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN	ACTIVE INGREDIENT	9GCJ1L5D1P	ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]	18
HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN	ACTIVE MOIETY	9GCJ1L5D1P	ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]	18
ALUMINUM HYDROXIDE	INACTIVE INGREDIENT	5QB0T2IUN0	ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]	18
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]	18
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	94255I6E2T	ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]	18
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	INACTIVE INGREDIENT	5QWK665956	ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]	18
HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN	ACTIVE INGREDIENT	9GCJ1L5D1P	ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [DISPENSING SOLUTIONS INC.]	1
HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN	ACTIVE MOIETY	9GCJ1L5D1P	ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [DISPENSING SOLUTIONS INC.]	1
ALUMINUM HYDROXIDE	INACTIVE INGREDIENT	5QB0T2IUN0	ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [DISPENSING SOLUTIONS INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [DISPENSING SOLUTIONS INC.]	1
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	94255I6E2T	ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [DISPENSING SOLUTIONS INC.]	1
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	INACTIVE INGREDIENT	5QWK665956	ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [DISPENSING SOLUTIONS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58160-821	ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]	33	Current NDC, Legacy NDC, 4 package rows	20250210_2ec65f7e-4aa2-4b41-b578-885ea59d6e9d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9GCJ1L5D1P	HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN	351186-51-1	HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
798428	ENGERIX-B adult 20 MCG in 1 ML Prefilled Syringe	PSN	dcecf9e0-6c28-4964-9ddb-9379705fa26c	42
798426	hepatitis B vaccine (recombinant) adult 20 MCG in 1 ML Prefilled Syringe	PSN	dcecf9e0-6c28-4964-9ddb-9379705fa26c	42
798428	1 ML hepatitis B surface antigen vaccine 0.02 MG/ML Prefilled Syringe [Engerix-B]	SBD	dcecf9e0-6c28-4964-9ddb-9379705fa26c	42
798426	1 ML hepatitis B surface antigen vaccine 0.02 MG/ML Prefilled Syringe	SCD	dcecf9e0-6c28-4964-9ddb-9379705fa26c	42
798428	1 ML Engerix-B (Adult Dose) 0.02 MG/ML Prefilled Syringe	SY	dcecf9e0-6c28-4964-9ddb-9379705fa26c	42
798428	1 ML Engerix-B 20 MCG/ML Prefilled Syringe	SY	dcecf9e0-6c28-4964-9ddb-9379705fa26c	42
798428	Engerix-B 20 MCG per 1 ML Prefilled Syringe	SY	dcecf9e0-6c28-4964-9ddb-9379705fa26c	42
798426	hepatitis B surface antigen vaccine 20 MCG/ML Prefilled Syringe, 1 ML	SY	dcecf9e0-6c28-4964-9ddb-9379705fa26c	42
1658157	ENGERIX-B adult 20 MCG in 1 ML Injection	PSN	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34
798428	ENGERIX-B adult 20 MCG in 1 ML Prefilled Syringe	PSN	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34
798430	ENGERIX-B pediatric/adolescent 10 MCG in 0.5 ML Prefilled Syringe	PSN	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34
1658156	hepatitis B vaccine (recombinant) adult 20 MCG in 1 ML Injection	PSN	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34
798426	hepatitis B vaccine (recombinant) adult 20 MCG in 1 ML Prefilled Syringe	PSN	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34
798429	hepatitis B vaccine (recombinant) pediatric/adolescent 10 MCG in 0.5 ML Prefilled Syringe	PSN	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34
798430	0.5 ML hepatitis B surface antigen vaccine 0.02 MG/ML Prefilled Syringe [Engerix-B]	SBD	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34
1658157	1 ML hepatitis B surface antigen vaccine 0.02 MG/ML Injection [Engerix-B]	SBD	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34
798428	1 ML hepatitis B surface antigen vaccine 0.02 MG/ML Prefilled Syringe [Engerix-B]	SBD	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34
798429	0.5 ML hepatitis B surface antigen vaccine 0.02 MG/ML Prefilled Syringe	SCD	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34
1658156	1 ML hepatitis B surface antigen vaccine 0.02 MG/ML Injection	SCD	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34
798426	1 ML hepatitis B surface antigen vaccine 0.02 MG/ML Prefilled Syringe	SCD	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34
798430	0.5 ML Engerix-B Pediatric 20 MCG/ML Prefilled Syringe	SY	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34
798428	1 ML Engerix-B (Adult Dose) 0.02 MG/ML Prefilled Syringe	SY	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34
798428	1 ML Engerix-B 20 MCG/ML Prefilled Syringe	SY	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34
798430	Engerix-B 10 MCG per 0.5 ML Prefilled Syringe	SY	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34
1658157	Engerix-B 20 MCG per 1 ML Injection	SY	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34
798428	Engerix-B 20 MCG per 1 ML Prefilled Syringe	SY	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34
798430	Engerix-B, Hepatitis B Surface Antigen Vaccine, Adsorbed (Pediatric Dose) 0.5 ML Prefilled Syringe	SY	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34
798429	hepatitis B surface antigen vaccine 0.01 MG per 0.5 ML Prefilled Syringe	SY	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34
798429	hepatitis B surface antigen vaccine 10 MCG per 0.5 ML Prefilled Syringe	SY	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34
1658156	hepatitis B surface antigen vaccine 20 MCG per 1 ML Injection	SY	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34
798426	hepatitis B surface antigen vaccine 20 MCG/ML Prefilled Syringe, 1 ML	SY	2ec65f7e-4aa2-4b41-b578-885ea59d6e9d	34

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58160-821-01	58160082101	1 mL in 1 VIAL	1 ml					Historical
58160-821-11	58160082111	10 VIAL in 1 CARTON (58160-821-11) / 1 mL in 1 VIAL (58160-821-01)	10 vial	2007-03-28	0000-00-00	No	No	Current
58160-821-34	58160082134	1 SYRINGE in 1 CARTON (58160-821-34) > 1 mL in 1 SYRINGE (58160-821-05)	1 syringe	2007-03-28	0000-00-00	No	No	Current
58160-821-43	58160082143	1 mL in 1 SYRINGE	1 ml					Historical
58160-821-52	58160082152	10 SYRINGE in 1 CARTON (58160-821-52) / 1 mL in 1 SYRINGE (58160-821-43)	10 syringe	2007-03-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ENGERIX-B	GlaxoSmithKline Biologicals SA	2026-05-14	VACCINE LABEL	34
ENGERIX-B	A-S Medication Solutions	2025-05-15	VACCINE LABEL	42

ENGERIX-B

Additional Listing Data#

Active Ingredients#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#