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

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

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 Type	VACCINE	Item Code (Source)	NDC:80777-287
Route of Administration	INTRAMUSCULAR

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:80777-287-92	10 in 1 CARTON
1	NDC:80777-287-07	0.25 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved drug other		08/29/2023

Labeler - Moderna US, Inc. (117626450)

Revised: 8/2023

Document Id: 530786f0-58d9-4370-88f0-6e98e4b85183

Set id: 530786f0-58d9-4370-88f0-6e98e4b85183

Version: 1

Effective Time: 20230829

Moderna US, Inc.