Label: NOVAVAX COVID-19 VACCINE, ADJUVANTED- nvx-cov2373 injection, suspension
- NDC Code(s): 80631-100-01, 80631-100-10
- Packager: Novavax, Inc.
- Category: VACCINE LABEL
Drug Label Information
Updated March 7, 2022
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 80631-100-10 novavax
10 Multi-Dose Vials
(10 doses of 0.5mL)
novavax
COVID-19 Vaccine, AdjuvantedSuspension for
Intramuscular InjectionFor use under Emergency Use Authorization
novavax NDC 80631-100-01
COVID-19 Vaccine, Adjuvanted
Suspension for Intramuscular Injection
Multi-dose vial (10 doses of 0.5mL)Record date/time of first
puncture:No Preservative
Date: Time:
For use under Emergency Use Authorization
See FDA-authorized Fact Sheet for dosage and
administration. Store at 2 to 8ºC (36 to 46ºF)
DO NOT FREEZE. Discard 6 hours after first
puncture when stored at 2 to 25°C (36 to 77°F)
Keep the vial in carton to protect from light
EXP: See www.NovavaxCovidVaccine.comManufactured for: Novavax, Inc., Gaithersburg, MD 20878
xxxxxx-xxx GTIN 0123456789
novavax
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INGREDIENTS AND APPEARANCE
NOVAVAX COVID-19 VACCINE, ADJUVANTED
nvx-cov2373 injection, suspensionProduct Information Product Type VACCINE Item Code (Source) NDC:80631-100 Route of Administration INTRAMUSCULAR Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SARS-COV-2 SPIKE GLYCOPROTEIN VACCINE ANTIGEN NVX-COV2373 (UNII: UK9AK2IN1P) (SARS-COV-2 SPIKE GLYCOPROTEIN VACCINE ANTIGEN NVX-COV2373 - UNII:UK9AK2IN1P) SARS-COV-2 SPIKE GLYCOPROTEIN VACCINE ANTIGEN NVX-COV2373 5 ug in 0.5 mL Inactive Ingredients Ingredient Name Strength CHOLESTEROL (UNII: 97C5T2UQ7J) MONOBASIC POTASSIUM PHOSPHATE (UNII: 4J9FJ0HL51) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM HYDROXIDE (UNII: 55X04QC32I) HYDROCHLORIC ACID (UNII: QTT17582CB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80631-100-10 10 in 1 CARTON 1 NDC:80631-100-01 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date emergency use authorization 01/31/2022 Labeler - Novavax, Inc. (808837520)