Home NDC 50090-1223-1 ENGERIX-B
Product NDC 50090-1223
Requested package NDC 50090-1223-1
11-digit product format 500901223
Labeler code 50090
Product ID 50090-1223_461dcfb9-3b96-47e1-8061-4d98a6a22f4f
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 2027-12-31
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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 50090-1223-0 2023-12-05 These 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 50090-1223-0 2023-12-05 These 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 50090-1223-1 2023-12-05 These 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 50090-1223-1 2023-12-05 These 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 50090-1223-0 2020-01-31 These 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 50090-1223-0 2020-01-31 These 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 50090-1223-1 2020-01-31 These 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 50090-1223-1 2020-01-31 These 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 NDC Product Description Form Quantity Strength SPL version 50090-1223-0 ENGERIX-B 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SUSPENSION 1 42 50090-1223-1 ENGERIX-B 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SUSPENSION 1 42 50090-1223-1 ENGERIX-B 1 in 1 POUCH INJECTION, SUSPENSION 1 42 50090-1223-2 ENGERIX-B 10 in 1 CARTON INJECTION, SUSPENSION 10 42
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-1223 ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS] 42 Current NDC, Legacy NDC, 4 package rows 20250516_dcecf9e0-6c28-4964-9ddb-9379705fa26c.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103239 Engerix-B Hepatitis B Vaccine (Recombinant) 351(a) Rx 2026-08-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 50090-1223-1 50090122301 1 VIAL, SINGLE-DOSE in 1 POUCH (50090-1223-1) / 1 mL in 1 VIAL, SINGLE-DOSE 2007-03-28 No No Current