Comirnaty Injection, Suspension
NDC 0069-2528
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Comirnaty (covid-19 vaccine, mrna) is a BLA-approved product labeled by Pfizer Laboratories Div Pfizer Inc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a injection, suspension for intramuscular administration. This product entry covers the primary NDC 0069-2528 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
0069-2528
Proprietary Name:
Comirnaty
Non-Proprietary Name: [1]
Covid-19 Vaccine, Mrna
Substance Name: [2]
Bnt162b2 Omicron (lp.8.1)
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Injection, Suspension
- A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route(s): [4]
Intramuscular - Administration within a muscle.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
0069
Product Label ID:
FDA Application Number: [6]
BLA125742
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
08-27-2025
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 0069-2528?
The NDC code 0069-2528 is assigned by the FDA to the product Comirnaty. It is commonly known by its generic name, covid-19 vaccine, mrna. This pharmaceutical product is labeled by Pfizer Laboratories Div Pfizer Inc and is currently categorized as listed product. The medication is a injection, suspension administered via intramuscular route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0069-2528-10. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
What are Active Ingredients of this product?
An 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.
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 2722598 - SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-BNT162b2 OMICRON (LP.8.1) 0.3 ML Prefilled Syringe, 12y+
- RxCUI: 2722598 - 0.3 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-BNT162b2 OMICRON (LP.8.1) 0.1 MG/ML Prefilled Syringe
- RxCUI: 2722605 - COMIRNATY 2025-2026 vaccine, 0.3 ML Prefilled Syringe, 12y+
- RxCUI: 2722605 - 0.3 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-BNT162b2 OMICRON (LP.8.1) 0.1 MG/ML Prefilled Syringe [Comirnaty 2025-2026]
- RxCUI: 2722605 - 0.3 ML Comirnaty 2025-2026 0.1 MG/ML Prefilled Syringe
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An 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.
What kind of product is this? Indicates 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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product 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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
