1/24/22, 4:50 PM Covid-19 Vaccine Novavax - FDA prescribing information, side effects and uses

Covid-19 Vaccine Novavax

Generic name: nvx-cov2373
Dosage form: injection, suspension

Package/Label Display Panel – Vial Label

NDC 80631-100-01

NOVAVAX

COVID-19 Vaccine,

Adjuvanted

Suspension for intramuscular injection

Multi-dose vial (10 doses of 0.5 mL)

Record date/time of first use:

Date: Time:

Manufactured for:
Novavax, Inc., Gaithersburg, MD 20878

Package/Label Display Panel – Vial Carton

NDC 80631-100-10

10 Multi-Dose Vials

(each vial contains 10 doses of 0.5 mL)

NOVAVAX

COVID-19 Vaccine, Adjuvanted

suspension for
intramuscular injection

For use under Emergency Use Authorization

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1/24/22, 4:50 PM Covid-19 Vaccine Novavax - FDA prescribing information, side effects and uses

NOVAVAX

NOVAVAX COVID-19 VACCINE, ADJUVANTED

nvx-cov2373 injection, suspension

Product Information

Product Type VACCINE Item Code (Source) NDC:80631-100

Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength

NVX-COV2373 (NVX-COV2373) NVX-COV2373 5 ug in 0.5 mL

Inactive Ingredients

Ingredient Name Strength

MONOBASIC POTASSIUM PHOSPHATE

POTASSIUM CHLORIDE

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

SODIUM CHLORIDE

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

POLYSORBATE 80

WATER

SODIUM HYDROXIDE

HYDROCHLORIC ACID

MATRIX-M1 ADJUVANT

Packaging

# Item Code Package Description

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1/24/22, 4:50 PM Covid-19 Vaccine Novavax - FDA prescribing information, side effects and uses

1 NDC:80631-100-10 10 VIAL, MULTI-DOSE in 1 CARTON

1 NDC:80631-100-01 5 mL in 1 VIAL, MULTI-DOSE

Marketing Information

Marketing Application Number or Monograph Marketing Start Marketing End

Category Citation Date Date

Unapproved drug 04/23/2021

other

Labeler - Novavax Inc. (808837520)

Registrant - Novavax Inc. (808837520)

Novavax Inc.

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