FDA.reportPublic FDA data

ENGERIX-B

Product NDC
50090-1223
11-digit product format
500901223
Labeler code
50090
Product ID
50090-1223_f61147dc-ce4b-477d-9e84-4c5b363e1a2f
Type
VACCINE
Nonproprietary name
Hepatitis B Vaccine (Recombinant)
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
A-S Medication Solutions
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
2026-12-31
Current FDA listing
Yes

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50090-1223-1fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50090-1223-0fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50090-1223-186f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50090-1223-086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50090-1223-1bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50090-1223-0bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50090-1223-18dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50090-1223-08dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50090-1223-1e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50090-1223-0e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50090-1223-19bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50090-1223-09bebd1f3094a…5416666fcb17…

Additional Listing Data#

Finished product
Yes
Brand name base
ENGERIX-B
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN20 ug/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-1223-02023-12-05These highlights do not include all the information needed to use ENGERIX-B safely and effectively. See full prescribing information for ENGERIX-B. ENGERIX-B [Hepatitis B Vaccine (Recombinant)] injectable suspension, for intramuscular use Initial U.S. Approval: 1989
50090-1223-12023-12-05These highlights do not include all the information needed to use ENGERIX-B safely and effectively. See full prescribing information for ENGERIX-B. ENGERIX-B [Hepatitis B Vaccine (Recombinant)] injectable suspension, for intramuscular use Initial U.S. Approval: 1989
50090-1223-02020-01-31These highlights do not include all the information needed to use ENGERIX-B safely and effectively. See full prescribing information for ENGERIX-B. ENGERIX-B [Hepatitis B Vaccine (Recombinant)] injectable suspension, for intramuscular use Initial U.S. Approval: 1989
50090-1223-12020-01-31These highlights do not include all the information needed to use ENGERIX-B safely and effectively. See full prescribing information for ENGERIX-B. ENGERIX-B [Hepatitis B Vaccine (Recombinant)] injectable suspension, for intramuscular use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1223-0ENGERIX-B1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION142
50090-1223-1ENGERIX-B1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION142
50090-1223-1ENGERIX-B1 in 1 POUCHINJECTION, SUSPENSION142
50090-1223-2ENGERIX-B10 in 1 CARTONINJECTION, SUSPENSION1042

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1223-0ML - Milliliter50090-1223cf1dfdc9-e161-43d8-9c13-518e19df0bf412018-11-06
50090-1223-1ML - Milliliter50090-1223aacef12e-43e9-41c1-acb7-1b4b81df918612018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1223ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]42Current NDC, Legacy NDC, 4 package rows20250516_dcecf9e0-6c28-4964-9ddb-9379705fa26c.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103239Engerix-BHepatitis B Vaccine (Recombinant)351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
798428ENGERIX-B adult 20 MCG in 1 ML Prefilled SyringePSNdcecf9e0-6c28-4964-9ddb-9379705fa26c42
798426hepatitis B vaccine (recombinant) adult 20 MCG in 1 ML Prefilled SyringePSNdcecf9e0-6c28-4964-9ddb-9379705fa26c42
7984281 ML hepatitis B surface antigen vaccine 0.02 MG/ML Prefilled Syringe [Engerix-B]SBDdcecf9e0-6c28-4964-9ddb-9379705fa26c42
7984261 ML hepatitis B surface antigen vaccine 0.02 MG/ML Prefilled SyringeSCDdcecf9e0-6c28-4964-9ddb-9379705fa26c42
7984281 ML Engerix-B (Adult Dose) 0.02 MG/ML Prefilled SyringeSYdcecf9e0-6c28-4964-9ddb-9379705fa26c42
7984281 ML Engerix-B 20 MCG/ML Prefilled SyringeSYdcecf9e0-6c28-4964-9ddb-9379705fa26c42
798428Engerix-B 20 MCG per 1 ML Prefilled SyringeSYdcecf9e0-6c28-4964-9ddb-9379705fa26c42
798426hepatitis B surface antigen vaccine 20 MCG/ML Prefilled Syringe, 1 MLSYdcecf9e0-6c28-4964-9ddb-9379705fa26c42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-1223-0500901223001 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
50090-1223-1500901223011 VIAL, SINGLE-DOSE in 1 POUCH (50090-1223-1) / 1 mL in 1 VIAL, SINGLE-DOSE2007-03-28NoNoCurrent
50090-1223-25009012230210 VIAL, SINGLE-DOSE in 1 CARTON (50090-1223-2) / 1 mL in 1 VIAL, SINGLE-DOSE (50090-1223-0) 2007-03-28NoNoCurrent