FDA.reportPublic FDA data

AS03

Manufacturer
GlaxoSmithKline Biologicals SA
Effective date
2025-12-31
Label type
VACCINE LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:52:18

Label at a glance#

ProductAS03
Label structure2 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Health Care Professional and Patient Fact Sheets are not available at this time.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58160-855-19

AS03 Adjuvant Component

NOTICE: NOT TO BE USED ALONE

One vial of AS03 Adjuvant Component and one vial of Antigen Component MUST BE COMBINED BEFORE USE.

10 Vials of AS03 Adjuvant Component

One vial of AS03 Adjuvant Component must be added to one vial of Antigen Component to form ten 0.5-mL doses of vaccine.

Rx only

Rev. 11/20

504407

AS03 Adjuvant 10 count carton
AS03 Adjuvant 10 count carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58160-855-192024-02-10C16284748780-11030e365-6622-111a-e063-dadaa90a10e2f136b41b-56f3-43a9-9d6a-61b2afca5b4a
58160-855-192024-01-30C16284748780-11030e365-6622-111a-e063-dadaa90a10e2f136b41b-56f3-43a9-9d6a-61b2afca5b4a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58160-855-01AS032.5 mL in 1 VIALINJECTION, SOLUTION2.53
58160-855-19AS0310 in 1 CARTONINJECTION, SOLUTION103

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58160-85558160-855-01, 58160-855-19

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
SQUALENE7QWM220FJHADJV
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01ADJV
POLYSORBATE 806OZP39ZG8HADJV

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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