Comirnaty Vaccine

Comirnaty by

Drug Labeling and Warnings

Comirnaty by is a Other medication manufactured, distributed, or labeled by Pfizer Laboratories Div Pfizer Inc, Pfizer Inc, Pfizer Manufacturing Belgium NV, Pharmacia & Upjohn Company LLC, Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC, BioNTech Manufacturing GmbH, BioNTech Manufacturing Marburg GmbH, Pfizer Ireland Pharmaceuticals, Labor LS SE & Co. KG, BioNTech Innovative Manufacturing Services GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

----------

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 – 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 – 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 – 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

COMIRNATY 
covid-19 vaccine, mrna injection, suspension

Product Information
Product Type	VACCINE	Item Code (Source)	NDC: 0069-2362
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RAXTOZINAMERAN (UNII: N36VHK46PR) (RAXTOZINAMERAN - UNII:N36VHK46PR)	RAXTOZINAMERAN	0.048 mg  in 0.48 mL

Inactive Ingredients
Ingredient Name	Strength
((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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0069-2362-10	10 in 1 CARTON
1	NDC: 0069-2362-01	0.48 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		08/21/2023

COMIRNATY 
covid-19 vaccine, mrna injection, suspension

Product Information
Product Type	VACCINE	Item Code (Source)	NDC: 0069-2392
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RAXTOZINAMERAN (UNII: N36VHK46PR) (RAXTOZINAMERAN - UNII:N36VHK46PR)	RAXTOZINAMERAN	0.043 mg  in 0.432 mL

Inactive Ingredients
Ingredient Name	Strength
((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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0069-2392-10	10 in 1 CARTON
1	NDC: 0069-2392-01	0.432 mL in 1 SYRINGE, GLASS; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		08/21/2023

Labeler - Pfizer Laboratories Div Pfizer Inc (134489525)

Registrant - Pfizer Inc (113480771)

Establishment
Name	Address	ID/FEI	Business Operations
Pfizer Manufacturing Belgium NV		370156507	PACK(0069-2362, 0069-2392) , MANUFACTURE(0069-2362, 0069-2392) , ANALYSIS(0069-2362, 0069-2392) , LABEL(0069-2362, 0069-2392)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmacia & Upjohn Company LLC		618054084	MANUFACTURE(0069-2362) , LABEL(0069-2362) , PACK(0069-2362) , ANALYSIS(0069-2362)

Establishment
Name	Address	ID/FEI	Business Operations
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC		174350868	ANALYSIS(0069-2362, 0069-2392) , API MANUFACTURE(0069-2362, 0069-2392)

Establishment
Name	Address	ID/FEI	Business Operations
BioNTech Manufacturing GmbH		314382536	ANALYSIS(0069-2362, 0069-2392)

Establishment
Name	Address	ID/FEI	Business Operations
BioNTech Manufacturing Marburg GmbH		313270335	ANALYSIS(0069-2362, 0069-2392) , API MANUFACTURE(0069-2362, 0069-2392)

Establishment
Name	Address	ID/FEI	Business Operations
Pfizer Ireland Pharmaceuticals		985586408	ANALYSIS(0069-2362, 0069-2392) , API MANUFACTURE(0069-2362, 0069-2392)

Establishment
Name	Address	ID/FEI	Business Operations
Labor LS SE & Co. KG		314929072	ANALYSIS(0069-2362, 0069-2392)

Establishment
Name	Address	ID/FEI	Business Operations
BioNTech Innovative Manufacturing Services GmbH		537365801	ANALYSIS(0069-2362, 0069-2392)

Revised: 8/2023

Document Id: fea45986-eb42-4fd2-93c5-8dcdbe8a1068

53404-0

Set id: ddd7c1e5-1098-481a-9d9c-e1359f8dde86

Version: 1

Effective Time: 20230821