PFIZER-BIONTECH COVID-19 VACCINE- bnt162b2 injection, suspension 
Pfizer Manufacturing Belgium NV

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Pfizer-BioNTech Covid-19 Vaccine

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

PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Label - 0078-1

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 years

BIONTECH
Pfizer

For 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, Germany

Manufactured by
Pfizer Inc.
New York, NY 10017

Rx only

GTIN: 00359267007827
LOT/MFG:
PAA177570

PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Carton Label - 0078-2

PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Carton - 0078-4

Pfizer-BioNTech
COVID-19 Vaccine
Suspension for Intramuscular Injection
DILUTE PRIOR TO USE
10 Multiple Dose Vials
After dilution each vial contains
10 doses of 0.2 mL
For age 2 years to < 5 years

BIONTECH
Pfizer

NDC 59267-0078-4

Rx only

PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Carton - 0078-4
PFIZER-BIONTECH COVID-19 VACCINE 
bnt162b2 injection, suspension
Product Information
Product TypeVACCINEItem Code (Source)NDC:59267-0078
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOZINAMERAN (UNII: 5085ZFP6SJ) (TOZINAMERAN - UNII:5085ZFP6SJ) TOZINAMERAN3 ug  in 0.2 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59267-0078-2195 in 1 CARTON
1NDC:59267-0078-12 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
2NDC:59267-0078-410 in 1 CARTON
2NDC:59267-0078-12 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
EMERGENCY USE AUTHORIZATION08/13/2021
Labeler - Pfizer Manufacturing Belgium NV (370156507)
Registrant - Pfizer Inc (113480771)
Establishment
NameAddressID/FEIBusiness Operations
Pfizer Manufacturing Belgium NV370156507ANALYSIS(59267-0078) , MANUFACTURE(59267-0078) , PACK(59267-0078) , LABEL(59267-0078)
Establishment
NameAddressID/FEIBusiness Operations
Pharmacia & Upjohn Company LLC618054084ANALYSIS(59267-0078) , MANUFACTURE(59267-0078) , PACK(59267-0078) , LABEL(59267-0078)
Establishment
NameAddressID/FEIBusiness Operations
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC174350868ANALYSIS(59267-0078) , API MANUFACTURE(59267-0078)
Establishment
NameAddressID/FEIBusiness Operations
Pfizer Inc004954111ANALYSIS(59267-0078)

Revised: 11/2021
Document Id: 5d96762d-8d1e-4bf8-8c60-88c580325a4c
Set id: 196608f2-21c1-4236-b3e1-06637f7be060
Version: 2
Effective Time: 20211101
 
Pfizer Manufacturing Belgium NV