Pfizer-BioNTech COVID-19 Vaccine, Bivalent Original and Omicron BA.4/BA.5

Pfizer-BioNTech Covid-19 Vaccine, Bivalent by

Drug Labeling and Warnings

Pfizer-BioNTech Covid-19 Vaccine, Bivalent by is a Other medication manufactured, distributed, or labeled by Pfizer Manufacturing Belgium NV, Pfizer Inc, Pharmacia & Upjohn Company LLC, BioNTech Innovative Manufacturing Services GmbH, BioNTech Manufacturing GmbH, BioNTech Manufacturing Marburg GmbH, Hospira, Inc., Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC, Pfizer Ireland Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT- original and omicron ba.4/ba.5 injection, suspension 
Pfizer Manufacturing Belgium NV

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Pfizer-BioNTech COVID-19 Vaccine, Bivalent
Original and Omicron BA.4/BA.5

PRINCIPAL DISPLAY PANEL

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PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT 
original and omicron ba.4/ba.5 injection, suspension

Product Information
Product Type	VACCINE	Item Code (Source)	NDC: 59267-0609
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOZINAMERAN (UNII: 5085ZFP6SJ) (TOZINAMERAN - UNII:5085ZFP6SJ)	TOZINAMERAN	0.02 mg  in 2.6 mL
BNT162B2 OMICRON (BA.4/BA.5) (UNII: JSV288Q5CV) (BNT162B2 OMICRON (BA.4/BA.5) - UNII:JSV288Q5CV)	BNT162B2 OMICRON (BA.4/BA.5)	0.02 mg  in 2.6 mL

Inactive Ingredients
Ingredient Name	Strength
2-(MPEG 2000)-N,N-DITETRADECYLACETAMIDE (UNII: PJH39UMU6H)	0.07 mg  in 2.6 mL
((4-HYDROXYBUTYL)AZANEDIYL)BIS(HEXANE-6,1-DIYL)BIS(2-HEXYLDECANOATE) (UNII: AVX8DX713V)	0.57 mg  in 2.6 mL
TROMETHAMINE (UNII: 023C2WHX2V)	0.08 mg  in 2.6 mL
TROMETHAMINE HYDROCHLORIDE (UNII: 383V75M34E)	0.53 mg  in 2.6 mL
SUCROSE (UNII: C151H8M554)	41.2 mg  in 2.6 mL
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: 043IPI2M0K)	0.12 mg  in 2.6 mL
CHOLESTEROL (UNII: 97C5T2UQ7J)	0.25 mg  in 2.6 mL
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)	19.8 mg  in 2.6 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59267-0609-2	10 in 1 CARTON
1	NDC: 59267-0609-1	2.6 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		08/15/2022	08/15/2022

Labeler - Pfizer Manufacturing Belgium NV (370156507)

Registrant - Pfizer Inc (113480771)

Establishment
Name	Address	ID/FEI	Business Operations
Pfizer Manufacturing Belgium NV		370156507	ANALYSIS(59267-0609) , MANUFACTURE(59267-0609) , PACK(59267-0609) , LABEL(59267-0609)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmacia & Upjohn Company LLC		618054084	ANALYSIS(59267-0609) , MANUFACTURE(59267-0609) , PACK(59267-0609) , LABEL(59267-0609)

Establishment
Name	Address	ID/FEI	Business Operations
BioNTech Innovative Manufacturing Services GmbH		537365801	ANALYSIS(59267-0609)

Establishment
Name	Address	ID/FEI	Business Operations
BioNTech Manufacturing GmbH		314382536	ANALYSIS(59267-0609) , API MANUFACTURE(59267-0609)

Establishment
Name	Address	ID/FEI	Business Operations
BioNTech Manufacturing Marburg GmbH		313270335	ANALYSIS(59267-0609) , API MANUFACTURE(59267-0609)

Establishment
Name	Address	ID/FEI	Business Operations
Hospira, Inc.		030606222	ANALYSIS(59267-0609) , MANUFACTURE(59267-0609) , PACK(59267-0609) , LABEL(59267-0609)

Establishment
Name	Address	ID/FEI	Business Operations
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC		174350868	ANALYSIS(59267-0609) , API MANUFACTURE(59267-0609)

Establishment
Name	Address	ID/FEI	Business Operations
Pfizer Inc		004954111	ANALYSIS(59267-0609)

Establishment
Name	Address	ID/FEI	Business Operations
Pfizer Ireland Pharmaceuticals		985586408	ANALYSIS(59267-0609)

Revised: 12/2022

Document Id: e7c342f0-c014-4e39-9494-e359ff7634bc

53404-0

Set id: 8003e2b9-ea36-4275-b0ba-673460fd6305

Version: 3

Effective Time: 20221212