FDA.reportPublic FDA data

ENGERIX-B

Product NDC
58160-820
11-digit product format
581600820
Labeler code
58160
Product ID
58160-820_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
2007-04-25
Substance
HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN
Active strength
10 ug/.5mL
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
IngredientStrength
HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN10 ug/.5mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58160-820-43ENGERIX-B0.5 mL in 1 SYRINGEINJECTION, SUSPENSION0.534
58160-820-52ENGERIX-B10 in 1 CARTONINJECTION, SUSPENSION1034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58160-820-01ML - Milliliter58160-820af919af3-adb6-4f20-bd16-28e48544b13412017-04-05
58160-820-11ML - Milliliter58160-8206f9daaa0-bfee-4d44-ae2b-98aea559f49512013-02-13
58160-820-43ML - Milliliter58160-8207012f0c1-e974-4f20-ae3b-9a1f737530bd12015-07-20
58160-820-52ML - Milliliter58160-8202aa3cd2c-f03a-4732-a589-ed2f8b62db0112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGENACTIVE INGREDIENT9GCJ1L5D1PENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]18
HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGENACTIVE MOIETY9GCJ1L5D1PENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]18
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]18
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]18
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]18
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEINACTIVE INGREDIENT5QWK665956ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58160-820ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]33Current NDC, Legacy NDC, 2 package rows20250210_2ec65f7e-4aa2-4b41-b578-885ea59d6e9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658157ENGERIX-B adult 20 MCG in 1 ML InjectionPSN2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
798428ENGERIX-B adult 20 MCG in 1 ML Prefilled SyringePSN2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
798430ENGERIX-B pediatric/adolescent 10 MCG in 0.5 ML Prefilled SyringePSN2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
1658156hepatitis B vaccine (recombinant) adult 20 MCG in 1 ML InjectionPSN2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
798426hepatitis B vaccine (recombinant) adult 20 MCG in 1 ML Prefilled SyringePSN2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
798429hepatitis B vaccine (recombinant) pediatric/adolescent 10 MCG in 0.5 ML Prefilled SyringePSN2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
7984300.5 ML hepatitis B surface antigen vaccine 0.02 MG/ML Prefilled Syringe [Engerix-B]SBD2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
16581571 ML hepatitis B surface antigen vaccine 0.02 MG/ML Injection [Engerix-B]SBD2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
7984281 ML hepatitis B surface antigen vaccine 0.02 MG/ML Prefilled Syringe [Engerix-B]SBD2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
7984290.5 ML hepatitis B surface antigen vaccine 0.02 MG/ML Prefilled SyringeSCD2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
16581561 ML hepatitis B surface antigen vaccine 0.02 MG/ML InjectionSCD2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
7984261 ML hepatitis B surface antigen vaccine 0.02 MG/ML Prefilled SyringeSCD2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
7984300.5 ML Engerix-B Pediatric 20 MCG/ML Prefilled SyringeSY2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
7984281 ML Engerix-B (Adult Dose) 0.02 MG/ML Prefilled SyringeSY2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
7984281 ML Engerix-B 20 MCG/ML Prefilled SyringeSY2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
798430Engerix-B 10 MCG per 0.5 ML Prefilled SyringeSY2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
1658157Engerix-B 20 MCG per 1 ML InjectionSY2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
798428Engerix-B 20 MCG per 1 ML Prefilled SyringeSY2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
798430Engerix-B, Hepatitis B Surface Antigen Vaccine, Adsorbed (Pediatric Dose) 0.5 ML Prefilled SyringeSY2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
798429hepatitis B surface antigen vaccine 0.01 MG per 0.5 ML Prefilled SyringeSY2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
798429hepatitis B surface antigen vaccine 10 MCG per 0.5 ML Prefilled SyringeSY2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
1658156hepatitis B surface antigen vaccine 20 MCG per 1 ML InjectionSY2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
798426hepatitis B surface antigen vaccine 20 MCG/ML Prefilled Syringe, 1 MLSY2ec65f7e-4aa2-4b41-b578-885ea59d6e9d34
798430ENGERIX-B pediatric/adolescent 10 MCG in 0.5 ML Prefilled SyringePSN9a4037a2-6c63-457a-8d6f-2fd05d926ea213
798429hepatitis B vaccine (recombinant) pediatric/adolescent 10 MCG in 0.5 ML Prefilled SyringePSN9a4037a2-6c63-457a-8d6f-2fd05d926ea213
7984300.5 ML hepatitis B surface antigen vaccine 0.02 MG/ML Prefilled Syringe [Engerix-B]SBD9a4037a2-6c63-457a-8d6f-2fd05d926ea213
7984290.5 ML hepatitis B surface antigen vaccine 0.02 MG/ML Prefilled SyringeSCD9a4037a2-6c63-457a-8d6f-2fd05d926ea213
7984300.5 ML Engerix-B Pediatric 20 MCG/ML Prefilled SyringeSY9a4037a2-6c63-457a-8d6f-2fd05d926ea213
798430Engerix-B 10 MCG per 0.5 ML Prefilled SyringeSY9a4037a2-6c63-457a-8d6f-2fd05d926ea213
798430Engerix-B, Hepatitis B Surface Antigen Vaccine, Adsorbed (Pediatric Dose) 0.5 ML Prefilled SyringeSY9a4037a2-6c63-457a-8d6f-2fd05d926ea213
798429hepatitis B surface antigen vaccine 0.01 MG per 0.5 ML Prefilled SyringeSY9a4037a2-6c63-457a-8d6f-2fd05d926ea213
798429hepatitis B surface antigen vaccine 10 MCG per 0.5 ML Prefilled SyringeSY9a4037a2-6c63-457a-8d6f-2fd05d926ea213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58160-820-43581600820430.5 mL in 1 SYRINGE0.5 mlHistorical
58160-820-525816008205210 SYRINGE in 1 CARTON (58160-820-52) / .5 mL in 1 SYRINGE (58160-820-43) 10 syringe2007-04-250000-00-00NoNoCurrent