COMIRNATY- covid-19 vaccine, mrna injection, suspension 
Pfizer Laboratories Div Pfizer Inc

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Comirnaty Vaccine

PRINCIPAL DISPLAY PANEL – 0.3 mL Single Dose Vial Label

COVID-19 Vaccine, mRNA
COMIRNATY ®
Rx only

2023 – 2024 Formula

DO NOT DILUTE
Age 12y & older

Vial contains 1 dose of 0.3 mL

For intramuscular use.
US License No. 2229
BioNTech Manufacturing GmbH & Pfizer Inc.

NDC 0069-2362-01

PRINCIPAL DISPLAY PANEL – 0.3 mL Single Dose Vial Label

PRINCIPAL DISPLAY PANEL – 10 Single Dose Vial Carton

NDC 0069-2362-10

COVID-19 Vaccine, mRNA
COMIRNATY ®

2023 – 2024 Formula

Suspension for Intramuscular Injection

DO NOT DILUTE

10 Single Dose Vials

Each vial contains 1 dose of 0.3 mL

For 12 years of age and older

BIONTECH
Pfizer
Rx only

PRINCIPAL DISPLAY PANEL – 10 Single Dose Vial Carton

PRINCIPAL DISPLAY PANEL – 0.3 mL Prefilled Syringe Label

NDC 0069-2392-01
LOT:/EXP:

XXXXXXXX

FPO

LOT:/EXP:

COVID-19 Vaccine, mRNA
COMIRNATY®

YYYY/MM/DD

Age 12y & older

Contains 1 dose
of 0.3 mL

For intramuscular use.
US License No. 2229
BioNTech Manufacturing
GmbH & Pfizer Inc.

NDC 0069-2392-01

Rx only

COVID-19
Vaccine, mRNA
COMIRNATY®

2023 – 2024 Formula

PRINCIPAL DISPLAY PANEL – 0.3 mL Prefilled Syringe Label

PRINCIPAL DISPLAY PANEL – 10 Prefilled Syringe Carton

NDC 0069-2392-10

COVID-19 Vaccine, mRNA
COMIRNATY ®

2023 – 2024 Formula

Suspension for Intramuscular Injection

10 Single Dose Prefilled Syringes

Each prefilled syringe contains 1 dose of 0.3 mL

For 12 years of age and older

BIONTECH
Pfizer
Rx only

PRINCIPAL DISPLAY PANEL – 10 Prefilled Syringe Carton
COMIRNATY 
covid-19 vaccine, mrna injection, suspension
Product Information
Product TypeVACCINEItem Code (Source)NDC:0069-2362
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RAXTOZINAMERAN (UNII: N36VHK46PR) (RAXTOZINAMERAN - UNII:N36VHK46PR) RAXTOZINAMERAN0.048 mg  in 0.48 mL
Inactive Ingredients
Ingredient NameStrength
((4-HYDROXYBUTYL)AZANEDIYL)BIS(HEXANE-6,1-DIYL)BIS(2-HEXYLDECANOATE) (UNII: AVX8DX713V) 0.69 mg  in 0.48 mL
2-(MPEG 2000)-N,N-DITETRADECYLACETAMIDE (UNII: PJH39UMU6H) 0.09 mg  in 0.48 mL
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: 043IPI2M0K) 0.15 mg  in 0.48 mL
CHOLESTEROL (UNII: 97C5T2UQ7J) 0.30 mg  in 0.48 mL
SUCROSE (UNII: C151H8M554) 49.44 mg  in 0.48 mL
TROMETHAMINE (UNII: 023C2WHX2V) 0.10 mg  in 0.48 mL
TROMETHAMINE HYDROCHLORIDE (UNII: 383V75M34E) 0.63 mg  in 0.48 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0069-2362-1010 in 1 CARTON
1NDC:0069-2362-010.48 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other08/21/2023
COMIRNATY 
covid-19 vaccine, mrna injection, suspension
Product Information
Product TypeVACCINEItem Code (Source)NDC:0069-2392
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RAXTOZINAMERAN (UNII: N36VHK46PR) (RAXTOZINAMERAN - UNII:N36VHK46PR) RAXTOZINAMERAN0.043 mg  in 0.432 mL
Inactive Ingredients
Ingredient NameStrength
((4-HYDROXYBUTYL)AZANEDIYL)BIS(HEXANE-6,1-DIYL)BIS(2-HEXYLDECANOATE) (UNII: AVX8DX713V) 0.618 mg  in 0.432 mL
2-(MPEG 2000)-N,N-DITETRADECYLACETAMIDE (UNII: PJH39UMU6H) 0.078 mg  in 0.432 mL
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: 043IPI2M0K) 0.134 mg  in 0.432 mL
CHOLESTEROL (UNII: 97C5T2UQ7J) 0.268 mg  in 0.432 mL
SUCROSE (UNII: C151H8M554) 44.5 mg  in 0.432 mL
TROMETHAMINE (UNII: 023C2WHX2V) 0.086 mg  in 0.432 mL
TROMETHAMINE HYDROCHLORIDE (UNII: 383V75M34E) 0.570 mg  in 0.432 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0069-2392-1010 in 1 CARTON
1NDC:0069-2392-010.432 mL in 1 SYRINGE, GLASS; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other08/21/2023
Labeler - Pfizer Laboratories Div Pfizer Inc (134489525)
Registrant - Pfizer Inc (113480771)
Establishment
NameAddressID/FEIBusiness Operations
Pfizer Manufacturing Belgium NV370156507PACK(0069-2362, 0069-2392) , MANUFACTURE(0069-2362, 0069-2392) , ANALYSIS(0069-2362, 0069-2392) , LABEL(0069-2362, 0069-2392)
Establishment
NameAddressID/FEIBusiness Operations
Pharmacia & Upjohn Company LLC618054084MANUFACTURE(0069-2362) , LABEL(0069-2362) , PACK(0069-2362) , ANALYSIS(0069-2362)
Establishment
NameAddressID/FEIBusiness Operations
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC174350868ANALYSIS(0069-2362, 0069-2392) , API MANUFACTURE(0069-2362, 0069-2392)
Establishment
NameAddressID/FEIBusiness Operations
BioNTech Manufacturing GmbH314382536ANALYSIS(0069-2362, 0069-2392)
Establishment
NameAddressID/FEIBusiness Operations
BioNTech Manufacturing Marburg GmbH313270335ANALYSIS(0069-2362, 0069-2392) , API MANUFACTURE(0069-2362, 0069-2392)
Establishment
NameAddressID/FEIBusiness Operations
Pfizer Ireland Pharmaceuticals985586408ANALYSIS(0069-2362, 0069-2392) , API MANUFACTURE(0069-2362, 0069-2392)
Establishment
NameAddressID/FEIBusiness Operations
Labor LS SE & Co. KG314929072ANALYSIS(0069-2362, 0069-2392)
Establishment
NameAddressID/FEIBusiness Operations
BioNTech Innovative Manufacturing Services GmbH537365801ANALYSIS(0069-2362, 0069-2392)

Revised: 8/2023
Document Id: fea45986-eb42-4fd2-93c5-8dcdbe8a1068
Set id: ddd7c1e5-1098-481a-9d9c-e1359f8dde86
Version: 1
Effective Time: 20230821
 
Pfizer Laboratories Div Pfizer Inc