FDA.reportPublic FDA data

PREHEVBRIO

Product NDC
75052-001
11-digit product format
750520001
Labeler code
75052
Product ID
75052-001_f1126e8c-6fd9-2ec9-e053-2995a90a9c24
Type
VACCINE
Nonproprietary name
Hepatitis B Vaccine (Recombinant)
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
VBI Vaccines (Delaware) Inc.
Application
BLA125737
Marketing category
BLA
Marketing start
2021-12-01
Marketing end
0000-00-00
Substance
RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM L /SCI-B-VAC); RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM M/SCI-B-VAC); RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM S/SCI-B-VAC)
Active strength
10 ug/mL; ug/mL; ug/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct75052-001IInactivated by FDA2026-10-05
excluded packagepackage75052-00175052-001-10IInactivated by FDA2026-10-05

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage75052-001-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage75052-001-10f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75052-001-102025-07-29C16284748780-13b156c62-312a-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use PREHEVBRIO TM safely and effectively. See full prescribing information for PREHEVBRIO. PREHEVBRIO [Hepatitis B Vaccine (Recombinant)] Injectable suspension, for intramuscular use Initial U.S. Approval: 2021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75052-001-01PREHEVBRIO1 mL in 1 VIAL, GLASSINJECTION, SUSPENSION16
75052-001-10PREHEVBRIO10 in 1 CARTONINJECTION, SUSPENSION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75052-001-01ML - Milliliter75052-001b0c8c71c-c3f9-46ff-a3c5-52c3e2eca77212022-02-07
75052-001-10ML - Milliliter75052-001893b43ad-57c5-4d07-badb-8347f8ac3adf12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75052-001PREHEVBRIO (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [VBI VACCINES (DELAWARE) INC.]6Legacy NDC, 2 package rows20240224_36e9a878-d6c2-4808-9915-294f47b1fe3d.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125737PrehevbrioHepatitis B Vaccine (Recombinant)351(a)Disc2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2588237Hepatitis B (Recombinant) Vaccine 1 ML InjectionPSN36e9a878-d6c2-4808-9915-294f47b1fe3d6
2588240PREHEVBRIO Hepatitis B (Recombinant) Vaccine 1 ML InjectionPSN36e9a878-d6c2-4808-9915-294f47b1fe3d6
25882401 ML hepatitis B surface antigen (isoform L), recombinant 0.01 MG/ML / hepatitis B surface antigen (isoform M), recombinant 0.01 MG/ML / hepatitis B surface antigen (isoform S), recombinant 0.01 MG/ML Injection [Prehevbrio]SBD36e9a878-d6c2-4808-9915-294f47b1fe3d6
25882371 ML hepatitis B surface antigen (isoform L), recombinant 0.01 MG/ML / hepatitis B surface antigen (isoform M), recombinant 0.01 MG/ML / hepatitis B surface antigen (isoform S), recombinant 0.01 MG/ML InjectionSCD36e9a878-d6c2-4808-9915-294f47b1fe3d6
2588240Prehevbrio vaccine 1 ML InjectionSY36e9a878-d6c2-4808-9915-294f47b1fe3d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75052-001-01750520001011 mL in 1 VIAL, GLASS1 mlHistorical
75052-001-107505200011010 VIAL, GLASS in 1 CARTON (75052-001-10) > 1 mL in 1 VIAL, GLASS (75052-001-01) 2021-12-010000-00-00NoNoCurrent