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

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

| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49281-618-20 | 2024-10-21 | C162847 | 48780-1 | f386c649-c5b6-0266-e053-dadaa90a7c1a | ANTIGEN COMPONENT |
| 49281-618-20 | 2023-01-30 | C162847 | 48780-1 | f386c649-c5b6-0266-e053-dadaa90a7c1a | ANTIGEN COMPONENT |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49281-618-20 | ML - Milliliter | 49281-618 | ea047f64-72a5-41c2-b64e-edd4d2e6bd5e | 1 | 2022-04-06 |
| 49281-618-78 | ML - Milliliter | 49281-618 | 2430666e-ed0b-43a2-9e86-b2f3120755c2 | 1 | 2022-04-06 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49281-618 | 49281-618-78, 49281-618-20 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| COV-2 PRES DTM ANTIGEN | 76SQ8FDG7I | ACTIB |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE | E1W4N241FO | IACT |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | IACT |
| POLYSORBATE 20 | 7T1F30V5YH | IACT |
Adverse event summaries are temporarily unavailable. Other product information remains available.