FDA.reportPublic FDA data

Shingrix

Product NDC
50090-5147
11-digit product format
500905147
Labeler code
50090
Product ID
50090-5147_268695c9-903d-4304-ade9-9eae53764f27
Type
VACCINE
Nonproprietary name
Zoster Vaccine Recombinant, Adjuvanted
Dosage form
KIT
Labeler
A-S Medication Solutions
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
2022-12-31
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 productproduct50090-5147IInactivated by FDA2026-07-31
excluded packagepackage50090-514750090-5147-0IInactivated by FDA2026-07-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5147-02023-01-30C16284748780-1f386c649-d313-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SHINGRIX safely and effectively. See full prescribing information for SHINGRIX. SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted), suspension for intramuscular injection Initial U.S. Approval: 2017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5147-0Shingrix1 in 1 KITKIT12
58160-828-01Shingrix0.5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,1 mL50 ug in 0.5mL2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5147-0EA - Each50090-5147b8f34d62-6596-49ea-afd0-e7a118411e9a12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5147SHINGRIX (ZOSTER VACCINE RECOMBINANT, ADJUVANTED) KIT [A-S MEDICATION SOLUTIONS]2Legacy NDC, 2 package rows20210416_e9ba0102-8cbb-4c4c-810e-292119095a8a.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125614ShingrixZoster Vaccine Recombinant, Adjuvanted351(a)Rx2026-06-01

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
50090-5147-0500905147001 KIT in 1 KIT (50090-5147-0) * .5 mL in 1 VIAL (58160-828-01) * .5 mL in 1 VIAL (58160-829-01) 1 kit2017-10-200000-00-00NoNoCurrent
58160-828-01581600828010.5 mL in 1 VIAL0.5 mlHistorical