ANTIGEN COMPONENT

Manufacturer
Sanofi Pasteur Inc.
Effective date
2020-11-09
Label type
VACCINE LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:07:00

Label at a glance#

ProductANTIGEN COMPONENT
Active ingredientCOV-2 PRES DTM ANTIGEN
Label structure3 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 - 10 Dose Vial Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49281-618-78
Vial 1 of 2
ANTIGEN COMPONENT
for Sanofi Pasteur COVID-19 Vaccine, Adjuvanted

After mixing, emulsion for intramuscular injection
For use under Emergency Use Authorization.
NOT TO BE USED ALONE.
Add 1 vial of AS03 Adjuvant Component to form the Vaccine.
Multiple Dose Vial (after mixing, contains 10 doses of 0.5 mL). After
mixing, hold at 23°C to 27°C (73°F to 80°F). Discard after 6 hours.
Refer to FDA-authorized Fact Sheet for mixing instructions.
No Preservative
Record date and time of mixing:
Manufactured by: Sanofi Pasteur Inc.

PRINCIPAL DISPLAY PANEL - 10 Vial Label
PRINCIPAL DISPLAY PANEL - 10 Vial Label

PRINCIPAL DISPLAY PANEL - 10 Vial Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49281-618-20
ANTIGEN COMPONENT
for Sanofi Pasteur COVID-19 Vaccine, Adjuvanted

After mixing, emulsion for intramuscular injection
For use under Emergency Use Authorization

CONTENTS: 10 Multiple Dose Vials (after mixing with AS03 Adjuvant Component,
each vial contains ten 0.5 mL doses of Vaccine)

NOTICE: NOT TO BE USED ALONE
One vial of AS03 Adjuvant Component MUST BE ADDED to one vial of
Antigen Component to form the Vaccine.

794426

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL - 10 Vial Carton
PRINCIPAL DISPLAY PANEL - 10 Vial Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49281-618-202024-10-21C16284748780-1f386c649-c5b6-0266-e053-dadaa90a7c1aANTIGEN COMPONENT
49281-618-202023-01-30C16284748780-1f386c649-c5b6-0266-e053-dadaa90a7c1aANTIGEN COMPONENT

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49281-618-20ML - Milliliter49281-618ea047f64-72a5-41c2-b64e-edd4d2e6bd5e12022-04-06
49281-618-78ML - Milliliter49281-6182430666e-ed0b-43a2-9e86-b2f3120755c212022-04-06

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49281-61849281-618-78, 49281-618-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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