MODERNA COVID-19 VACCINE- moderna covid-19 vaccine 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

Moderna COVID-19 Vaccine 2023-2024 Formula Suspension for Intramuscular Injection Single Dose Vial 0.25 mL

Moderna COVID-19 Vaccine

2023-2024 Formula

For Intramuscular Use

For use under EUA

For 6m through 11y

0.25 mL Single Dose Vial

Mfd. for: Moderna US, Inc.

NDC 80777-287-07

Package/Label Display Panel

Moderna COVID-19 Vaccine 2023-2024 Formula Suspension for Intramuscular Injection Single Dose Vial Carton 0.25 mL

NDC 80777-287-92

Moderna

Moderna COVID-19 Vaccine

Suspension for Intramuscular Injection

2023-2024 Formula

For use under Emergency Use Authorization

For 6 months through 11 years

STORE FROZEN between -50°C to -15°C (-58°F to 5°F)

Protect from light

10 Single Dose Vials

Each dose is 0.25 mL

MODERNA COVID-19 VACCINE 
moderna covid-19 vaccine injection, suspension
Product Information
Product TypeVACCINEItem Code (Source)NDC:80777-287
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)25 ug  in 0.25 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:80777-287-9210 in 1 CARTON
1NDC:80777-287-070.25 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
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
 
Moderna US, Inc.