Shingrix

Product NDC
58160-849
11-digit product format
581600849
Labeler code
58160
Product ID
58160-849_e8a2f0fb-062a-4adc-ac30-f378fbcf87ed
Type
VACCINE
Nonproprietary name
Zoster Vaccine Recombinant, Adjuvanted
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
GlaxoSmithKline Biologicals SA
Application
BLA125614
Marketing category
BLA
Marketing start
2025-07-16
Substance
RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN
Active strength
50 ug/.5mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Related Records

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58160-849-525816008495210 SYRINGE in 1 CARTON (58160-849-52) / .5 mL in 1 SYRINGE (58160-849-43) 10 syringe2025-07-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ShingrixA-S Medication Solutions2026-03-06VACCINE LABEL1
ShingrixGlaxoSmithKline Biologicals SA2026-02-13VACCINE LABEL23
ShingrixGlaxoSmithKline Biologicals SA2025-07-16VACCINE LABEL21