Home NDC 50090-1223 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.
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 Units Marketing start Sample Exclude flag Status 50090-1223-0 50090122300 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 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 50090-1223-2 50090122302 10 VIAL, SINGLE-DOSE in 1 CARTON (50090-1223-2) / 1 mL in 1 VIAL, SINGLE-DOSE (50090-1223-0) 2007-03-28 No No Current