FDA Label for Spikevax
View Indications, Usage & Precautions
Spikevax Product Label
The following document was submitted to the FDA by the labeler of this product Moderna Us, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Package/Label Display Panel
Rx Only
COIVD-19 Vaccine, mRNA
SpikevaxTM
2023-2024 Formula
Suspension for Intramuscular Injection
For 12 years and older
Multiple-Dose Vial
Each dose is 0.5 mL
Each vial contains 5 doses
NDC 80777-102-05
NDC 80777-102-97
Moderna
COVID-19 Vaccine, mRNA
SpikevaxTM
2023-2024 Formula
Suspension for Intramuscular Injection
For 12 years and older
Rx Only
Store frozen between -50°C to -15°C (-58°F to 5°F)
Protect from light
10 Multiple-Dose Vials
Each dose is 0.5 mL
Each vial contains 5 doses
COIVD-19 Vaccine, mRNA
SpikevaxTM
2023-2024 Formula
For Intramuscular Use
For 12y and older
0.5 mL Single Dose Vial
Mfd. for: Moderna US, Inc.
NDC 80777-102-04
Rx Only
NDC 80777-102-95
Moderna
COVID-19 Vaccine, mRNA
SpikevaxTM
2023-2024 Formula
Suspension for Intramuscular Injection
For 12 years and older
Rx Only
Store frozen between -50°C to -15°C (-58°F to 5°F)
Protect from light
10 Single Dose Vials
Each dose is 0.5 mL
COVID-19 Vaccine, mRNA
SpikevaxTM
2023-2024 Formula
For 12 years and older
NDC 80777-102-01
0.5 mL Single Dose
Rx Only
For IM Use
Mfd. for: Moderna US, Inc.
NDC 80777-102-96
Moderna
For 12 years and older
Rx Only
COVID-19 Vaccine, mRNA
SpikevaxTM
2023-2024 Formula
Suspension for Intramuscular Injection
Store frozen between -50°C to -15°C (-58°F to 5°F)
Protect from light
10 Single Dose Pre-Filled Syringes
Each dose is 0.5 mL
NDC 80777-102-93
Moderna
COVID-19 Vaccine, mRNA
SpikevaxTM
2023-2024 Formula
Suspension for Intramuscular Injection
For 12 years and older
Rx Only
Store frozen between -50°C to -15°C (-58°F to 5°F)
Protect from light
10 Single Dose Pre-Filled Syringes
Each dose is 0.5 mL
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