FDA.reportPublic FDA data

Shingrix

Product NDC
58160-819
11-digit product format
581600819
Labeler code
58160
Product ID
58160-819_c4aade10-3ea5-4dfd-bda5-a240b9b2978d
Type
VACCINE
Nonproprietary name
Zoster Vaccine Recombinant, Adjuvanted
Dosage form
KIT
Labeler
GlaxoSmithKline Biologicals SA
Application
BLA125614
Marketing category
BLA
Marketing start
2017-10-20
Marketing end
0000-00-00
Active strength
0
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 productproduct58160-819DDiscontinued by firm2026-10-12
excluded packagepackage58160-81958160-819-12DDiscontinued by firm2026-10-12

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 packagepackage58160-819-12d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58160-819-12f5e01cc5f278…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
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58160-819-12EA - Each58160-81911daa83d-9d82-49c2-8682-8cb0defd046612017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58160-819SHINGRIX (ZOSTER VACCINE RECOMBINANT, ADJUVANTED) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]19Legacy NDC20250327_0280849d-5c78-4a9d-8941-4eab429f6bd8.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125614ShingrixZoster Vaccine Recombinant, Adjuvanted351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1986830SHINGRIX vaccine 0.5 ML InjectionPSNe9ba0102-8cbb-4c4c-810e-292119095a8a2
1986825varicella zoster virus glycoprotein E vaccine recombinant 0.1 MG/mL InjectionPSNe9ba0102-8cbb-4c4c-810e-292119095a8a2
19868300.5 ML varicella zoster virus glycoprotein E, recombinant 0.1 MG/ML Injection [Shingrix]SBDe9ba0102-8cbb-4c4c-810e-292119095a8a2
19868250.5 ML varicella zoster virus glycoprotein E, recombinant 0.1 MG/ML InjectionSCDe9ba0102-8cbb-4c4c-810e-292119095a8a2
19868300.5 ML Shingrix 0.1 MG/ML InjectionSYe9ba0102-8cbb-4c4c-810e-292119095a8a2
19868250.5 ML zoster vaccine, recombinant 0.1 MG/MLSYe9ba0102-8cbb-4c4c-810e-292119095a8a2
1986830Shingrix vaccine 0.5 ML InjectionSYe9ba0102-8cbb-4c4c-810e-292119095a8a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58160-819-12581600819121 KIT in 1 CARTON (58160-819-12) * .5 mL in 1 VIAL (58160-828-01) * .5 mL in 1 VIAL (58160-829-01) 1 kit2017-10-200000-00-00NoNoCurrent