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

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PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT 
original and omicron ba.4/ba.5 injection, suspension
Product Information
Product TypeVACCINEItem Code (Source)NDC:59267-0609
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOZINAMERAN (UNII: 5085ZFP6SJ) (TOZINAMERAN - UNII:5085ZFP6SJ) TOZINAMERAN0.02 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 NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59267-0609-210 in 1 CARTON
1NDC:59267-0609-12.6 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 AUTHORIZATION08/15/202208/15/2022
Labeler - Pfizer Manufacturing Belgium NV (370156507)
Registrant - Pfizer Inc (113480771)
Establishment
NameAddressID/FEIBusiness Operations
Pfizer Manufacturing Belgium NV370156507ANALYSIS(59267-0609) , MANUFACTURE(59267-0609) , PACK(59267-0609) , LABEL(59267-0609)
Establishment
NameAddressID/FEIBusiness Operations
Pharmacia & Upjohn Company LLC618054084ANALYSIS(59267-0609) , MANUFACTURE(59267-0609) , PACK(59267-0609) , LABEL(59267-0609)
Establishment
NameAddressID/FEIBusiness Operations
BioNTech Innovative Manufacturing Services GmbH537365801ANALYSIS(59267-0609)
Establishment
NameAddressID/FEIBusiness Operations
BioNTech Manufacturing GmbH314382536ANALYSIS(59267-0609) , API MANUFACTURE(59267-0609)
Establishment
NameAddressID/FEIBusiness Operations
BioNTech Manufacturing Marburg GmbH313270335ANALYSIS(59267-0609) , API MANUFACTURE(59267-0609)
Establishment
NameAddressID/FEIBusiness Operations
Hospira, Inc.030606222ANALYSIS(59267-0609) , MANUFACTURE(59267-0609) , PACK(59267-0609) , LABEL(59267-0609)
Establishment
NameAddressID/FEIBusiness Operations
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC174350868ANALYSIS(59267-0609) , API MANUFACTURE(59267-0609)
Establishment
NameAddressID/FEIBusiness Operations
Pfizer Inc004954111ANALYSIS(59267-0609)
Establishment
NameAddressID/FEIBusiness Operations
Pfizer Ireland Pharmaceuticals985586408ANALYSIS(59267-0609)

Revised: 12/2022
 
Pfizer Manufacturing Belgium NV