Vaccine Information: Moderna COVID-19 Vaccine

MODERNA COVID-19 VACCINE- cx-024414 injection, suspension
Moderna US, Inc.

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 Suspension for Intramuscular Injection for use under Emergency Use Authorization-Age 6mo through 5y Multi-Dose Vial (10 doses of 0.25 mL)
(click image for full-size original)

NDC 80777-279-05

Moderna COVID-19 Vaccine

Suspension for Intramuscular Injection

For use under Emergency Use Authorization

Age 6mo through 5y

Vial contains 10 doses of 0.25 mL

Package/Label Display Panel

Moderna COVID-19 Vaccine Suspension for Intramuscular Injection for use under Emergency Use Authorization-Age 6mo through 5y Carton (10 doses of 0.25 mL)
(click image for full-size original)

NDC 80777-279-99

Moderna COVID-19 Vaccine

Suspension for Intramuscular Injection

For use under Emergency Use Authorization

For age 6 months through 5 years

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

Protect from light

Ten multi-dose vials

Each vial contains 10 doses of 0.25 mL

MODERNA COVID-19 VACCINE
cx-024414 injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:80777-279
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CX-024414 (ELASOMERAN) CX-024414 0.1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SM-102
CHOLESTEROL
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE
1,2-DIMYRISTOYL-RAC-GLYCERO-3-METHOXYPOLYETHYLENE GLYCOL 2000
TROMETHAMINE
TROMETHAMINE HYDROCHLORIDE
ACETIC ACID
SODIUM ACETATE
SUCROSE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80777-279-99 10 VIAL in 1 CARTON contains a VIAL (80777-279-05)
1 NDC:80777-279-05 2.5 mL in 1 VIAL This package is contained within the CARTON (80777-279-99)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 04/12/2022
Labeler — Moderna US, Inc. (117626450)
Establishment
Name Address ID/FEI Operations
ModernaTX, Inc. 116912313 ANALYSIS (80777-279), API MANUFACTURE (80777-279)
Establishment
Name Address ID/FEI Operations
Catalent Indiana, LLC 172209277 MANUFACTURE (80777-279), ANALYSIS (80777-279), LABEL (80777-279), PACK (80777-279)

Revised: 04/2022 Moderna US, Inc.

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