Moderna COVID-19 Vaccine: Package Insert and Label Information (Page 5 of 5)

Package/Label Display Panel

Moderna COVID-19 Vaccine Suspension for Intramuscular Injection for use under Emergency Use Authorization Carton (maximum 11 doses of 0.5 mL)
(click image for full-size original)

NDC 80777-273-99

Moderna COVID-19 Vaccine

Suspension for Intramuscular Injection

For use under Emergency Use Authorization

Contents: 10 multiple-dose vials (each vial contains maximum of 11 doses of 0.5 mL).

Protect from light

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

Package/Label Display Panel

Moderna COVID-19 Vaccine Suspension for Intramuscular Injection for use under Emergency Use Authorization Multiple-dose Vial (maximum 11 doses of 0.5 mL)
(click image for full-size original)

NDC 80777-273-10

Moderna COVID-19 Vaccine

Suspension for Intramuscular Injection

For use under Emergency Use Authorization

Multiple-dose vial

(maximum 11 doses of 0.5 mL)

Package/Label Display Panel

Moderna COVID-19 Vaccine Suspension for Intramuscular Injection for use under Emergency Use Authorization Multiple-dose Vial (maximum 15 doses of 0.5 mL)
(click image for full-size original)

NDC 80777-273-15

Moderna COVID-19 Vaccine

Suspension for Intramuscular Injection

For use under Emergency Use Authorization

Multiple-dose vial

(maximum 15 doses of 0.5 mL)

Package/Label Display Panel

Moderna COVID-19 Vaccine Suspension for Intramuscular Injection for use under Emergency Use Authorization Carton (maximum 15 doses of 0.5 mL)
(click image for full-size original)

NDC 80777-273-98

Moderna COVID-19 Vaccine

Suspension for Intramuscular Injection

For use under Emergency Use Authorization

Contents: 10 multiple-dose vials (each vial contains maximum of 15 doses of 0.5 mL).

Protect from light

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

MODERNA COVID-19 VACCINE cx-024414 injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:80777-273
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CX-024414 (CX-024414) CX-024414 0.2 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:80777-273-99 10 VIAL in 1 CARTON contains a VIAL (80777-273-10)
1 NDC:80777-273-10 5 mL in 1 VIAL This package is contained within the CARTON (80777-273-99)
2 NDC:80777-273-98 10 VIAL in 1 CARTON contains a VIAL (80777-273-15)
2 NDC:80777-273-15 7.5 mL in 1 VIAL This package is contained within the CARTON (80777-273-98)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/18/2020
Labeler — Moderna US, Inc. (117626450)
Establishment
Name Address ID/FEI Operations
Lonza Biologics, Inc. 093149750 analysis (80777-273), api manufacture (80777-273)
Establishment
Name Address ID/FEI Operations
ModernaTX, Inc. 116912313 analysis (80777-273), api manufacture (80777-273)
Establishment
Name Address ID/FEI Operations
Catalent Indiana, LLC 172209277 manufacture (80777-273), label (80777-273), pack (80777-273)

Revised: 09/2021 Moderna US, Inc.

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

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.