Spikevax Injection, Suspension - FDA Label NDC 80777-113

The following Structured Product Label (SPL) was submitted to the FDA by Moderna Us, Inc. for the product Spikevax (NDC 80777-113). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package/label display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package/Label Display Panel

Spikevax (covid-19 Vaccine, Mrna) 2023-2024 Formula Suspension For Intramuscular Injection Multiple-dose Vial 2.5 mL (Image 01)

Rx Only

COIVD-19 Vaccine, mRNA

Spikevax^TM

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

Spikevax (covid-19 Vaccine, Mrna) 2023-2024 Formula Suspension For Intramuscular Injection Multiple-dose Vial Carton 2.5 mL (Image 02)

NDC 80777-102-97

Moderna

COVID-19 Vaccine, mRNA

Spikevax^TM

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

Spikevax (covid-19 Vaccine, Mrna) 2023-2024 Formula Suspension For Intramuscular Injection Single Dose Vial 0.5 mL (Image 03)

COIVD-19 Vaccine, mRNA

Spikevax^TM

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

Spikevax (covid-19 Vaccine, Mrna) 2023-2024 Formula Suspension For Intramuscular Injection Single Dose Vial Carton 0.5 mL (Image 04)

NDC 80777-102-95

Moderna

COVID-19 Vaccine, mRNA

Spikevax^TM

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

Spikevax (covid-19 Vaccine, Mrna) 2023-2024 Formula Suspension For Intramuscular Injection Single Dose Pre-filled Syringe 0.5 mL (Image 05)

COVID-19 Vaccine, mRNA

Spikevax^TM

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.

Spikevax (covid-19 Vaccine, Mrna) 2023-2024 Formula Suspension For Intramuscular Injection Single Dose Pre-filled Syringe Carton 0.5 mL (80777-102-96) (Image 06)

NDC 80777-102-96

Moderna

For 12 years and older

Rx Only

COVID-19 Vaccine, mRNA

Spikevax^TM

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

Spikevax (covid-19 Vaccine, Mrna) 2023-2024 Formula Suspension For Intramuscular Injection Single Dose Pre-filled Syringe Carton 0.5 mL (80777-102-93) (Image 07)

NDC 80777-102-93

Moderna

COVID-19 Vaccine, mRNA

Spikevax^TM

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

Spikevax Injection, Suspension
FDA Label NDC 80777-113

Structured Product Label

Label Section Quick Index

Package/Label Display Panel