59267-1000 NDC - PFIZER-BIONTECH COVID-19 VACCINE (BNT162B2)

Drug Information

Product NDC: 59267-1000

Proprietary Name: Pfizer-BioNTech Covid-19 Vaccine

Non Proprietary Name: BNT162b2

Active Ingredient(s):
  • .225 mg/2.25mL TOZINAMERAN


Administration Route(s): INTRAMUSCULAR

Dosage Form(s): INJECTION, SUSPENSION

Labeler Information

Labeler Name: Pfizer Manufacturing Belgium NV
Product Type: VACCINE
FDA Application Number:
Marketing Category: EMERGENCY USE AUTHORIZATION
Start Marketing Date:12/12/2020

Package Information

No. Package Code Package Description Billing Unit
159267-1000-2195 VIAL, GLASS in 1 CARTON (59267-1000-2) / 2.25 mL in 1 VIAL, GLASS (59267-1000-1)
259267-1000-325 VIAL, GLASS in 1 CARTON (59267-1000-3) / 2.25 mL in 1 VIAL, GLASS (59267-1000-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC59267-1000The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEVACCINEIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEPfizer-BioNTech Covid-19 VaccineThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEBNT162b2The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SUSPENSIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAMUSCULARThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE12/12/2020This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEEMERGENCY USE AUTHORIZATIONProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMEPfizer Manufacturing Belgium NVName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMETOZINAMERANAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH.225 
ACTIVE INGRED UNITmg/2.25mL 

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This page was last updated on: 2/1/2023