FDA.reportPublic FDA data

Shingrix

Product NDC
50090-3372
Requested package NDC
50090-3372-0
11-digit product format
500903372
Labeler code
50090
Product ID
50090-3372_6f4fbb1a-709b-4f96-86de-4ff86fbb30c2
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
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-337250090-3372-0DDiscontinued by firm2026-07-31

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
50090-3372-02023-02-07C16284748780-1f386c649-c992-0266-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
50090-3372-02023-01-30C16284748780-1f386c649-c992-0266-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
50090-3372-0Shingrix1 in 1 KITKIT16
58160-828-03Shingrix0.5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,10 mL50 ug in 0.5mL6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3372-0EA - Each50090-3372b2874be8-a718-43ce-8139-7fbeb476497a12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3372SHINGRIX (ZOSTER VACCINE RECOMBINANT, ADJUVANTED) KIT [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20240110_279a251c-f4d0-4c47-b999-7ef1a45ac0d0.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 InjectionPSN279a251c-f4d0-4c47-b999-7ef1a45ac0d06
1986825varicella zoster virus glycoprotein E vaccine recombinant 0.1 MG/mL InjectionPSN279a251c-f4d0-4c47-b999-7ef1a45ac0d06
19868300.5 ML varicella zoster virus glycoprotein E, recombinant 0.1 MG/ML Injection [Shingrix]SBD279a251c-f4d0-4c47-b999-7ef1a45ac0d06
19868250.5 ML varicella zoster virus glycoprotein E, recombinant 0.1 MG/ML InjectionSCD279a251c-f4d0-4c47-b999-7ef1a45ac0d06
19868300.5 ML Shingrix 0.1 MG/ML InjectionSY279a251c-f4d0-4c47-b999-7ef1a45ac0d06
19868250.5 ML zoster vaccine, recombinant 0.1 MG/MLSY279a251c-f4d0-4c47-b999-7ef1a45ac0d06
1986830Shingrix vaccine 0.5 ML InjectionSY279a251c-f4d0-4c47-b999-7ef1a45ac0d06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3372-0500903372001 KIT in 1 KIT (50090-3372-0) * .5 mL in 1 VIAL (58160-828-03) * .5 mL in 1 VIAL (58160-829-03) 1 kit2017-10-200000-00-00NoNoCurrent