Label: PFIZER-BIONTECH COVID-19 VACCINE- bnt162b2 injection, suspension
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NDC Code(s):
59267-0078-1,
59267-0078-2,
59267-0078-4,
59267-1025-1, view more59267-1025-2, 59267-1025-3, 59267-1025-4, 59267-1055-1, 59267-1055-2, 59267-1055-4
- Packager: Pfizer Manufacturing Belgium NV
- Category: VACCINE LABEL
- DEA Schedule: None
Drug Label Information
Updated August 13, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PRINCIPAL DISPLAY PANEL - 0.3 mL Vial Label - 1025-1
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PRINCIPAL DISPLAY PANEL - 0.3 mL Vial Carton Label - 1025-2
NDC 59267-1025-2
Pfizer-BioNTech COVID-19 Vaccine
Suspension for Intramuscular Injection
DO NOT DILUTE
195 Multiple Dose VialsEach vial contains
6 doses of 0.3 mLFor 12 years of age and older
BIONTECH
PfizerFor storage and expiry information, see
FDA-authorized Fact Sheet or scan QR code.
Store in this carton to protect from light.
After first use, store the vaccine at 2°C to 25°C (35°F to 77°F).
Discard 6 hours after first use. Contains no preservative.
For use under Emergency Use Authorization.
Rx onlyManufactured for
BioNTech
Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, GermanyManufactured by
Pfizer Inc.
New York, NY 10017PAA177759
LOT:
MFG:
- PRINCIPAL DISPLAY PANEL - 0.3 mL Vial Carton - 1025-3
- PRINCIPAL DISPLAY PANEL - 0.3 mL Vial Carton - 1025-4
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PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Label - 1055-1
Pfizer-BioNTech COVID-19 Vaccine
DILUTE PRIOR TO USE
Age 5y to < 12y
After dilution - 10 doses of 0.2 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 6 hours.
Dilution date and time:NDC 59267-1055-1
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PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Carton Label - 1055-2
NDC 59267-1055-2
Pfizer-BioNTech COVID-19 Vaccine
Suspension for Intramuscular Injection
DILUTE PRIOR TO USE
195 Multiple Dose Vials
After dilution each vial contains
10 doses of 0.2 mL
For age 5 years to < 12 yearsBIONTECH
PfizerFor storage and expiry information, see
FDA-authorized Fact Sheet or scan QR code.
Store in this carton to protect from light.
MUST BE DILUTED BEFORE USE with sterile
0.9% Sodium Chloride Injection, USP (not supplied).
After dilution, store the vaccine at 2°C to 25°C (35°F to 77°F).
Discard 6 hours after dilution. Contains no preservative.
For use under Emergency Use Authorization.Manufactured for
BioNTech
Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, GermanyManufactured by
Pfizer Inc.
New York, NY 10017Rx only
GTIN: 00359267105523
LOT/MFG:
PAA177912
- PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Carton - 1055-4
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PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Label - 0078-1
Pfizer-BioNTech COVID-19 Vaccine
DILUTE PRIOR TO USE
Age 2y to < 5y
After dilution - 10 doses of 0.2 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 6 hours.
Dilution date and time:NDC 59267-0078-1
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PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Carton Label - 0078-2
NDC 59267-0078-2
Pfizer-BioNTech COVID-19 Vaccine
Suspension for Intramuscular Injection
DILUTE PRIOR TO USE
195 Multiple Dose Vials
After dilution each vial contains
10 doses of 0.2 mL
For age 2 years to < 5 yearsBIONTECH
PfizerFor storage and expiry information, see
FDA-authorized Fact Sheet or scan QR code.
Store in this carton to protect from light.
MUST BE DILUTED BEFORE USE with sterile
0.9% Sodium Chloride Injection, USP (not supplied).
After dilution, store the vaccine at 2°C to 25°C (35°F to 77°F).
Discard 6 hours after dilution. Contains no preservative.
For use under Emergency Use Authorization.Manufactured for
BioNTech
Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, GermanyManufactured by
Pfizer Inc.
New York, NY 10017Rx only
GTIN: 00359267007827
LOT/MFG:
PAA177570
- PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Carton - 0078-4
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INGREDIENTS AND APPEARANCE
PFIZER-BIONTECH COVID-19 VACCINE
bnt162b2 injection, suspensionProduct Information Product Type VACCINE Item Code (Source) NDC:59267-1025 Route of Administration INTRAMUSCULAR Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOZINAMERAN (UNII: 5085ZFP6SJ) (TOZINAMERAN - UNII:5085ZFP6SJ) TOZINAMERAN 0.225 mg in 2.25 mL Inactive Ingredients Ingredient Name Strength ALC-0159 (UNII: PJH39UMU6H) 0.41 mg in 2.25 mL ALC-0315 (UNII: AVX8DX713V) 3.22 mg in 2.25 mL TROMETHAMINE (UNII: 023C2WHX2V) 0.45 mg in 2.25 mL TROMETHAMINE HYDROCHLORIDE (UNII: 383V75M34E) 3 mg in 2.25 mL SUCROSE (UNII: C151H8M554) 231.8 mg in 2.25 mL 1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: 043IPI2M0K) 0.7 mg in 2.25 mL CHOLESTEROL (UNII: 97C5T2UQ7J) 1.4 mg in 2.25 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59267-1025-2 195 in 1 CARTON 1 NDC:59267-1025-1 2.25 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product 2 NDC:59267-1025-3 25 in 1 CARTON 2 NDC:59267-1025-1 2.25 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product 3 NDC:59267-1025-4 10 in 1 CARTON 3 NDC:59267-1025-1 2.25 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date EMERGENCY USE AUTHORIZATION 08/13/2021 PFIZER-BIONTECH COVID-19 VACCINE
bnt162b2 injection, suspensionProduct Information Product Type VACCINE Item Code (Source) NDC:59267-1055 Route of Administration INTRAMUSCULAR Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOZINAMERAN (UNII: 5085ZFP6SJ) (TOZINAMERAN - UNII:5085ZFP6SJ) TOZINAMERAN 10 ug in 0.2 mL Inactive Ingredients Ingredient Name Strength ALC-0159 (UNII: PJH39UMU6H) ALC-0315 (UNII: AVX8DX713V) TROMETHAMINE (UNII: 023C2WHX2V) TROMETHAMINE HYDROCHLORIDE (UNII: 383V75M34E) SUCROSE (UNII: C151H8M554) 1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: 043IPI2M0K) CHOLESTEROL (UNII: 97C5T2UQ7J) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59267-1055-2 195 in 1 CARTON 1 NDC:59267-1055-1 2 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product 2 NDC:59267-1055-4 10 in 1 CARTON 2 NDC:59267-1055-1 2 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date EMERGENCY USE AUTHORIZATION 08/13/2021 PFIZER-BIONTECH COVID-19 VACCINE
bnt162b2 injection, suspensionProduct Information Product Type VACCINE Item Code (Source) NDC:59267-0078 Route of Administration INTRAMUSCULAR Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOZINAMERAN (UNII: 5085ZFP6SJ) (TOZINAMERAN - UNII:5085ZFP6SJ) TOZINAMERAN 3 ug in 0.2 mL Inactive Ingredients Ingredient Name Strength ALC-0159 (UNII: PJH39UMU6H) ALC-0315 (UNII: AVX8DX713V) TROMETHAMINE (UNII: 023C2WHX2V) TROMETHAMINE HYDROCHLORIDE (UNII: 383V75M34E) SUCROSE (UNII: C151H8M554) 1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: 043IPI2M0K) CHOLESTEROL (UNII: 97C5T2UQ7J) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59267-0078-2 195 in 1 CARTON 1 NDC:59267-0078-1 2 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product 2 NDC:59267-0078-4 10 in 1 CARTON 2 NDC:59267-0078-1 2 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date EMERGENCY USE AUTHORIZATION 08/13/2021 Labeler - Pfizer Manufacturing Belgium NV (370156507) Registrant - Pfizer Inc (113480771) Establishment Name Address ID/FEI Business Operations Pfizer Manufacturing Belgium NV 370156507 ANALYSIS(59267-0078, 59267-1025, 59267-1055) , MANUFACTURE(59267-0078, 59267-1025, 59267-1055) , PACK(59267-0078, 59267-1025, 59267-1055) , LABEL(59267-0078, 59267-1025, 59267-1055) Establishment Name Address ID/FEI Business Operations Pharmacia & Upjohn Company LLC 618054084 ANALYSIS(59267-0078, 59267-1025, 59267-1055) , MANUFACTURE(59267-0078, 59267-1025, 59267-1055) , PACK(59267-0078, 59267-1025, 59267-1055) , LABEL(59267-0078, 59267-1025, 59267-1055) Establishment Name Address ID/FEI Business Operations Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC 174350868 ANALYSIS(59267-0078, 59267-1025, 59267-1055) , API MANUFACTURE(59267-0078, 59267-1025, 59267-1055) Establishment Name Address ID/FEI Business Operations Pfizer Inc 004954111 ANALYSIS(59267-0078, 59267-1025, 59267-1055) Establishment Name Address ID/FEI Business Operations Polymun Scientific Immunbiologische Forschung GmbH 301584660 API MANUFACTURE(59267-0078, 59267-1025, 59267-1055)
