PFIZER-BIONTECH COVID-19 VACCINE- rna ingredient bnt-162b2 injection, suspension 
Pfizer Manufacturing Belgium NV

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Pfizer-BioNTech COVID-19 Vaccine

PRINCIPAL DISPLAY PANEL - 1.8 mL Vial Label

PAA156051
LOT/EXP

Pfizer-BioNTech COVID-19 Vaccine
After dilution, vial contains 5 doses of 0.3 mL

For intramuscular use. Contains no preservative.

For use under Emergency Use Authorization.

DILUTE BEFORE USE. Discard 6 hours after
dilution when stored at 2 to 25°C (35 to 77°F).

Dilution date and time:

NDC 59267-1000-1

Principal Display Panel - 1.8 mL Vial Label

PRINCIPAL DISPLAY PANEL - 195 Vial Carton

NDC 59267-1000-2

Pfizer-BioNTech COVID-19 Vaccine
Suspension for Intramuscular Injection

195 Multiple Dose Vials
(after dilution each vial contains
5 doses of 0.3 mL)

Pfizer | BIONTECH

STORAGE: Prior to dilution, store at
-80°C to -60°C (-112°F to -76°F).
Store in this carton to protect from light.

DOSAGE AND ADMINISTRATION: After
dilution, each vial contains 5 doses of 0.3 mL.
See FDA-authorized Fact Sheet or scan
QR code for information.

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 after 6 hours.
Contains no preservative.
For use under Emergency Use Authorization.

Rx only

Manufactured by
Pfizer Inc
New York, NY 10017

Manufactured for
BioNTech
Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany

PAA156052

LOT:
EXP:

Principal Display Panel - 195 Vial Carton
PFIZER-BIONTECH COVID-19 VACCINE 
rna ingredient bnt-162b2 injection, suspension
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59267-1000
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RNA ingredient BNT-162B2 (UNII: 5085ZFP6S) (RNA ingredient BNT-162B2 - UNII:5085ZFP6S) RNA ingredient BNT-162B20.23 g  in 1.8 mL
Inactive Ingredients
Ingredient NameStrength
lipid ALC-0159 (UNII: PJH39UMU6H)  
lipid ALC-0315 (UNII: AVX8DX713V)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
MONOBASIC POTASSIUM PHOSPHATE (UNII: 4J9FJ0HL51)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59267-1000-2195 in 1 CARTON11/04/2020
1NDC:59267-1000-11.8 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
2NDC:59267-1000-325 in 1 CARTON11/04/2020
21.8 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER11/04/2020
Labeler - Pfizer Manufacturing Belgium NV (370156507)
Registrant - Pfizer Inc (113480771)
Establishment
NameAddressID/FEIBusiness Operations
Pfizer Manufacturing Belgium NV370156507PACK(59267-1000) , MANUFACTURE(59267-1000) , ANALYSIS(59267-1000) , LABEL(59267-1000)
Establishment
NameAddressID/FEIBusiness Operations
Pharmacia and Upjohn Company LLC618054084MANUFACTURE(59267-1000) , LABEL(59267-1000) , PACK(59267-1000) , ANALYSIS(59267-1000)
Establishment
NameAddressID/FEIBusiness Operations
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC174350868ANALYSIS(59267-1000) , API MANUFACTURE(59267-1000)
Establishment
NameAddressID/FEIBusiness Operations
Pfizer Inc004954111ANALYSIS(59267-1000)

Revised: 11/2020
 
Pfizer Manufacturing Belgium NV