FDA.reportPublic FDA data

HEPLISAV-B

Product NDC
50090-3469
11-digit product format
500903469
Labeler code
50090
Product ID
50090-3469_83f8cd57-8c8a-476d-95d4-44524e0ebaa2
Type
VACCINE
Nonproprietary name
Hepatitis B Vaccine (Recombinant) Adjuvanted
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
A-S Medication Solutions
Application
BLA125428
Marketing category
BLA
Marketing start
2018-01-01
Marketing end
0000-00-00
Substance
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN
Active strength
20 ug/.5mL
Pharmacologic classes
Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [CS],Vaccines, Inactivated [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-3469DDiscontinued by firm2026-07-31
excluded packagepackage50090-346950090-3469-0DDiscontinued by firm2026-07-31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3469-0ML - Milliliter50090-346927104a1d-6b0d-4d71-a359-80bd81bcf56012018-11-06

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125428Heplisav-BHepatitis B Vaccine (Recombinant), Adjuvanted351(a)Rx2026-06-01