Vaccine Information: PFIZER-BIONTECH COVID-19 VACCINE
PFIZER-BIONTECH COVID-19 VACCINE- raxtozinameran injection, suspension
Pfizer Manufacturing Belgium NV
PRINCIPAL DISPLAY PANEL – 3 doses of 0.3 mL Multiple Dose Vial Label
Pfizer-BioNTech COVID-19 Vaccine
2023 – 2024 Formula
DILUTE PRIOR TO USE
Age 6m to < 5y
After dilution – 3 doses of 0.3 mL
For intramuscular use. Contains no preservative.
For use under Emergency Use Authorization.
After dilution store at 2 to 25°C (35 to 77°F) and
discard after 12 hours.Dilution date and time:
NDC 59267-4315-1
PRINCIPAL DISPLAY PANEL – 10 Multiple Dose Vial Carton
NDC 59267-4315-2
Pfizer-BioNTech
COVID-19 Vaccine
2023 – 2024 Formula
Suspension for Intramuscular Injection
DILUTE PRIOR TO USE
10 Multiple Dose Vials
After dilution each vial contains 3 doses of 0.3 mL
For age 6 months to < 5 years
For use under Emergency Use Authorization.
BIONTECH
PfizerRx only
PRINCIPAL DISPLAY PANEL – 0.3 mL Single Dose Vial Label
Pfizer-BioNTech COVID-19 Vaccine
2023 – 2024 Formula
DO NOT DILUTE
Age 5y to < 12y
Vial contains 1 dose of 0.3 mL
For intramuscular use.
For use under Emergency Use Authorization.
NDC 59267-4331-1
PRINCIPAL DISPLAY PANEL – 10 Single Dose Vial Carton
NDC 59267-4331-2
Pfizer-BioNTech
COVID-19 Vaccine
2023 – 2024 Formula
Suspension for Intramuscular Injection
DO NOT DILUTE
10 Single Dose Vials
Each vial contains 1 dose of 0.3 mL
For age 5 years to < 12 years
For use under Emergency Use Authorization.
BIONTECH
PfizerRx only
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PFIZER-BIONTECH COVID-19 VACCINE covid-19 vaccine, mrna injection, suspension | ||||||||||||||||||||
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Labeler — Pfizer Manufacturing Belgium NV (370156507) |
Registrant — Pfizer Inc (113480771) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Pfizer Manufacturing Belgium NV | 370156507 | PACK (59267-4315), PACK (59267-4331), MANUFACTURE (59267-4315), MANUFACTURE (59267-4331), ANALYSIS (59267-4315), ANALYSIS (59267-4331), LABEL (59267-4315), LABEL (59267-4331) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | 174350868 | ANALYSIS (59267-4315), ANALYSIS (59267-4331), API MANUFACTURE (59267-4315), API MANUFACTURE (59267-4331) |
Establishment | |||
Name | Address | ID/FEI | Operations |
BioNTech Manufacturing GmbH | 314382536 | ANALYSIS (59267-4315), ANALYSIS (59267-4331) |
Establishment | |||
Name | Address | ID/FEI | Operations |
BioNTech Manufacturing Marburg GmbH | 313270335 | ANALYSIS (59267-4315), ANALYSIS (59267-4331), API MANUFACTURE (59267-4315), API MANUFACTURE (59267-4331) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Pfizer Ireland Pharmaceuticals | 985586408 | ANALYSIS (59267-4315), ANALYSIS (59267-4331), API MANUFACTURE (59267-4315), API MANUFACTURE (59267-4331) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Labor LS SE & Co. KG | 314929072 | ANALYSIS (59267-4315), ANALYSIS (59267-4331) |
Establishment | |||
Name | Address | ID/FEI | Operations |
BioNTech Innovative Manufacturing Services GmbH | 537365801 | ANALYSIS (59267-4315), ANALYSIS (59267-4331) |
Revised: 08/2023 Pfizer Manufacturing Belgium NV
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