Pfizer-BioNTech Vaccine

PFIZER-BIONTECH COVID-19 VACCINE by

Drug Labeling and Warnings

PFIZER-BIONTECH COVID-19 VACCINE by is a Other medication manufactured, distributed, or labeled by Pfizer Manufacturing Belgium NV, Pfizer Inc, Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC, BioNTech Manufacturing GmbH, BioNTech Manufacturing Marburg GmbH, Pfizer Ireland Pharmaceuticals, Labor LS SE & Co. KG, BioNTech Innovative Manufacturing Services GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PFIZER-BIONTECH COVID-19 VACCINE- covid-19 vaccine, mrna injection, suspension 
Pfizer Manufacturing Belgium NV

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Pfizer-BioNTech Vaccine

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
Pfizer
Rx 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
Pfizer
Rx only

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RAXTOZINAMERAN (UNII: N36VHK46PR) (RAXTOZINAMERAN - UNII:N36VHK46PR)	RAXTOZINAMERAN	0.0158 mg  in 1.58 mL

Inactive Ingredients
Ingredient Name	Strength
((4-HYDROXYBUTYL)AZANEDIYL)BIS(HEXANE-6,1-DIYL)BIS(2-HEXYLDECANOATE) (UNII: AVX8DX713V)	0.227 mg  in 1.58 mL
2-(MPEG 2000)-N,N-DITETRADECYLACETAMIDE (UNII: PJH39UMU6H)	0.028 mg  in 1.58 mL
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: 043IPI2M0K)	0.048 mg  in 1.58 mL
CHOLESTEROL (UNII: 97C5T2UQ7J)	0.1 mg  in 1.58 mL
SUCROSE (UNII: C151H8M554)	49.44 mg  in 1.58 mL
TROMETHAMINE (UNII: 023C2WHX2V)	0.10 mg  in 1.58 mL
TROMETHAMINE HYDROCHLORIDE (UNII: 383V75M34E)	0.63 mg  in 1.58 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)	9.9 mg  in 1.58 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59267-4315-2	10 in 1 CARTON
1	NDC: 59267-4315-1	1.58 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
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RAXTOZINAMERAN (UNII: N36VHK46PR) (RAXTOZINAMERAN - UNII:N36VHK46PR)	RAXTOZINAMERAN	0.0158 mg  in 0.48 mL

Inactive Ingredients
Ingredient Name	Strength
((4-HYDROXYBUTYL)AZANEDIYL)BIS(HEXANE-6,1-DIYL)BIS(2-HEXYLDECANOATE) (UNII: AVX8DX713V)	0.227 mg  in 0.48 mL
2-(MPEG 2000)-N,N-DITETRADECYLACETAMIDE (UNII: PJH39UMU6H)	0.028 mg  in 0.48 mL
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: 043IPI2M0K)	0.048 mg  in 0.48 mL
CHOLESTEROL (UNII: 97C5T2UQ7J)	0.1 mg  in 0.48 mL
SUCROSE (UNII: C151H8M554)	49.44 mg  in 0.48 mL
TROMETHAMINE (UNII: 023C2WHX2V)	0.10 mg  in 0.48 mL
TROMETHAMINE HYDROCHLORIDE (UNII: 383V75M34E)	0.63 mg  in 0.48 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59267-4331-2	10 in 1 CARTON
1	NDC: 59267-4331-1	0.48 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product

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	Business Operations
Pfizer Manufacturing Belgium NV		370156507	PACK(59267-4315, 59267-4331) , MANUFACTURE(59267-4315, 59267-4331) , ANALYSIS(59267-4315, 59267-4331) , LABEL(59267-4315, 59267-4331)

Establishment
Name	Address	ID/FEI	Business Operations
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC		174350868	ANALYSIS(59267-4315, 59267-4331) , API MANUFACTURE(59267-4315, 59267-4331)

Establishment
Name	Address	ID/FEI	Business Operations
BioNTech Manufacturing GmbH		314382536	ANALYSIS(59267-4315, 59267-4331)

Establishment
Name	Address	ID/FEI	Business Operations
BioNTech Manufacturing Marburg GmbH		313270335	ANALYSIS(59267-4315, 59267-4331) , API MANUFACTURE(59267-4315, 59267-4331)

Establishment
Name	Address	ID/FEI	Business Operations
Pfizer Ireland Pharmaceuticals		985586408	ANALYSIS(59267-4315, 59267-4331) , API MANUFACTURE(59267-4315, 59267-4331)

Establishment
Name	Address	ID/FEI	Business Operations
Labor LS SE & Co. KG		314929072	ANALYSIS(59267-4315, 59267-4331)

Establishment
Name	Address	ID/FEI	Business Operations
BioNTech Innovative Manufacturing Services GmbH		537365801	ANALYSIS(59267-4315, 59267-4331)

Revised: 8/2023

Document Id: 5de9e848-8dce-4c6c-a674-f7e1d9588938

53404-0

Set id: 5de9e848-8dce-4c6c-a674-f7e1d9588938

Version: 1

Effective Time: 20230821