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 – Multiple Dose Vial Label
(click image for full-size original)

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 – 10 Multiple Dose Vial Carton
(click image for full-size original)

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 – 0.3 mL Single Dose Vial Label
(click image for full-size original)

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

PRINCIPAL DISPLAY PANEL – 10 Single Dose Vial Carton
(click image for full-size original)
PFIZER-BIONTECH COVID-19 VACCINE covid-19 vaccine, mrna injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:59267-4315
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RAXTOZINAMERAN (RAXTOZINAMERAN) RAXTOZINAMERAN 0.0158 mg in 1.58 mL
Inactive Ingredients
Ingredient Name Strength
((4-HYDROXYBUTYL)AZANEDIYL)BIS(HEXANE-6,1-DIYL)BIS(2-HEXYLDECANOATE) 0.227 mg in 1.58 mL
2-(MPEG 2000)-N,N-DITETRADECYLACETAMIDE 0.028 mg in 1.58 mL
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE 0.048 mg in 1.58 mL
CHOLESTEROL 0.1 mg in 1.58 mL
SUCROSE 49.44 mg in 1.58 mL
TROMETHAMINE 0.10 mg in 1.58 mL
TROMETHAMINE HYDROCHLORIDE 0.63 mg in 1.58 mL
SODIUM CHLORIDE 9.9 mg in 1.58 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59267-4315-2 10 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (59267-4315-1)
1 NDC:59267-4315-1 1.58 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (59267-4315-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 08/21/2023
PFIZER-BIONTECH COVID-19 VACCINE covid-19 vaccine, mrna injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:59267-4331
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RAXTOZINAMERAN (RAXTOZINAMERAN) RAXTOZINAMERAN 0.0158 mg in 0.48 mL
Inactive Ingredients
Ingredient Name Strength
((4-HYDROXYBUTYL)AZANEDIYL)BIS(HEXANE-6,1-DIYL)BIS(2-HEXYLDECANOATE) 0.227 mg in 0.48 mL
2-(MPEG 2000)-N,N-DITETRADECYLACETAMIDE 0.028 mg in 0.48 mL
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE 0.048 mg in 0.48 mL
CHOLESTEROL 0.1 mg in 0.48 mL
SUCROSE 49.44 mg in 0.48 mL
TROMETHAMINE 0.10 mg in 0.48 mL
TROMETHAMINE HYDROCHLORIDE 0.63 mg in 0.48 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59267-4331-2 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (59267-4331-1)
1 NDC:59267-4331-1 0.48 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (59267-4331-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 08/21/2023
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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