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 2.5 mL Multi-Dose Vial
(click image for full-size original)

NDC 80777-275-05

Moderna COVID-19 Vaccine

Suspension for Intramuscular Injection

For use under Emergency Use Authorization

2.5 mL Multi-Dose Vial

Booster Dose: 0.5 mL

Package/Label Display Panel

Moderna COVID-19 Vaccine Suspension for Intramuscular Injection for use under Emergency Use Authorization 2.5 mL Carton
(click image for full-size original)

NDC 80777-275-99

Moderna COVID-19 Vaccine

Suspension for Intramuscular Injection

For use under Emergency Use Authorization

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

Protect from light

Ten multi-dose vials containing 2.5 mL

Booster Dose: 0.5 mL

MODERNA COVID-19 VACCINE
cx-024414 injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:80777-275
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CX-024414 (CX-024414) 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:80777-275-99 10 VIAL in 1 CARTON contains a VIAL (80777-275-05)
1 NDC:80777-275-05 2.5 mL in 1 VIAL This package is contained within the CARTON (80777-275-99)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/03/2022
Labeler — Moderna US, Inc. (117626450)
Establishment
Name Address ID/FEI Operations
ModernaTX, Inc. 116912313 ANALYSIS (80777-275), API MANUFACTURE (80777-275)
Establishment
Name Address ID/FEI Operations
Lonza Biologics, Inc. 093149750 ANALYSIS (80777-275), API MANUFACTURE (80777-275)
Establishment
Name Address ID/FEI Operations
Catalent Indiana, LLC 172209277 MANUFACTURE (80777-275), LABEL (80777-275), PACK (80777-275)
Establishment
Name Address ID/FEI Operations
Baxter Pharmaceutical Solutions, LLC 604719430 MANUFACTURE (80777-275), ANALYSIS (80777-275), LABEL (80777-275), PACK (80777-275)

Revised: 12/2021 Moderna US, Inc.

VxLabels.com provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VxLabels.com. Every individual vaccine label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Vaccine Sections

Vaccine Information by RSS

As the leading independent provider of trustworthy vaccine information, our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VxLabels.com provides the full vaccine subset of the FDA's repository. Vaccine information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.