Pfizer-BioNTech Vaccine: Package Insert / Prescribing Info

Package insert / product label
Generic name: covid-19 vaccine, mrna
Dosage form: injection, suspension
Drug class: Viral vaccines

Medically reviewed by Drugs.com. Last updated on Oct 17, 2023.

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

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 – 10 Multiple Dose Vial Carton

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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

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

PRINCIPAL DISPLAY PANEL – 10 Single Dose Vial Carton

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

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

Ingredient Name	Strength
Inactive Ingredients
((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)

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
((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)

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved drug other		08/21/2023

Labeler - Pfizer Manufacturing Belgium NV (370156507)

Registrant - Pfizer Inc (113480771)

Name	Address	ID/FEI	Business Operations
Establishment
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)

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

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

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

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

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

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

Frequently asked questions

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Medical Disclaimer

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

User Reviews & Ratings

7.1 / 10

17 Reviews