SPIKEVAX- covid-19 vaccine, mrna injection, suspension 
Moderna US, Inc.

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DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS AND USAGE

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

General

Information for Patients

Laboratory Tests

Interactions

Drug Interactions

Drug/Laboratory Test Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy

Labor and Delivery

Nursing Mothers

Pediatric Use

Geriatric Use

ADVERSE REACTIONS

DRUG ABUSE AND DEPENDENCE

Controlled Substance

Abuse

Dependence

OVERDOSAGE

DOSAGE AND ADMINISTRATION

HOW SUPPLIED

Package/Label Display Panel

Spikevax (COVID-19 Vaccine, mRNA) 2023-2024 Formula Suspension for Intramuscular Injection Multiple-Dose Vial 2.5 mL

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

Package/Label Display Panel

Spikevax (COVID-19 Vaccine, mRNA) 2023-2024 Formula Suspension for Intramuscular Injection Multiple-Dose Vial Carton 2.5 mL

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

Package/Label Display Panel

Spikevax (COVID-19 Vaccine, mRNA) 2023-2024 Formula Suspension for Intramuscular Injection Single Dose Vial 0.5 mL

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

Package/Label Display Panel

Spikevax (COVID-19 Vaccine, mRNA) 2023-2024 Formula Suspension for Intramuscular Injection Single Dose Vial Carton 0.5 mL

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

Package/Label Display Panel

Spikevax (COVID-19 Vaccine, mRNA) 2023-2024 Formula Suspension for Intramuscular Injection Single Dose Pre-Filled Syringe 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.

Package/Label Display Panel

Spikevax (COVID-19 Vaccine, mRNA) 2023-2024 Formula Suspension for Intramuscular Injection Single Dose Pre-Filled Syringe Carton 0.5 mL (80777-102-96)

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

Package/Label Display Panel

Spikevax (COVID-19 Vaccine, mRNA) 2023-2024 Formula Suspension for Intramuscular Injection Single Dose Pre-Filled Syringe Carton 0.5 mL (80777-102-93)

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

SPIKEVAX 
covid-19 vaccine, mrna injection, suspension
Product Information
Product TypeVACCINEItem Code (Source)NDC:80777-102
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CX-038839 OMICRON (XBB.1.5) (UNII: 4F9QRS7ZV2) (CX-038839 OMICRON (XBB.1.5) - UNII:4F9QRS7ZV2) CX-038839 OMICRON (XBB.1.5)50 ug  in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
SM-102 (UNII: T7OBQ65G2I)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: 043IPI2M0K)  
1,2-DIMYRISTOYL-RAC-GLYCERO-3-METHOXYPOLYETHYLENE GLYCOL 2000 (UNII: 9X2596CIE0)  
TROMETHAMINE (UNII: 023C2WHX2V)  
TROMETHAMINE HYDROCHLORIDE (UNII: 383V75M34E)  
ACETIC ACID (UNII: Q40Q9N063P)  
SODIUM ACETATE (UNII: 4550K0SC9B)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80777-102-9710 in 1 CARTON
1NDC:80777-102-052.5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:80777-102-9510 in 1 CARTON
2NDC:80777-102-040.5 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
3NDC:80777-102-9610 in 1 CARTON
3NDC:80777-102-010.5 mL in 1 SYRINGE, PLASTIC; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
4NDC:80777-102-9310 in 1 CARTON
4NDC:80777-102-010.5 mL in 1 SYRINGE, PLASTIC; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other08/29/2023
Labeler - Moderna US, Inc. (117626450)

Revised: 8/2023
Document Id: f96b315c-fa57-4876-a7e5-a9b584d8e6e6
Set id: f96b315c-fa57-4876-a7e5-a9b584d8e6e6
Version: 1
Effective Time: 20230829
 
Moderna US, Inc.