Comirnaty Injection, Suspension
NDC Package 0069-2501-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Comirnaty (covid-19 vaccine, mrna) injection is 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. This formulation utilizes a injection, suspension delivery system. Marketed by Pfizer Laboratories Div Pfizer Inc, this product is identified by NDC 0069-2501 and is authorized under FDA application BLA125742.

Identification & Billing

NDC Package Code
0069-2501-10
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / .48 mL in 1 VIAL, SINGLE-DOSE (0069-2501-01)
Product Code
0069-2501
11-Digit Billing Format
00069250110
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Comirnaty
Non-Proprietary Name
Covid-19 Vaccine, Mrna
Substance Name
Bnt162b2 Omicron (lp.8.1)
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
Intramuscular - Administration within a muscle.
Active Ingredient(s)
BNT162B2 OMICRON (LP.8.1) .0158 mg/.48mL
Usage Information
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.

Regulatory & Marketing

Labeler Name
Pfizer Laboratories Div Pfizer Inc
Product Type
Vaccine
FDA Application #
BLA125742
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-27-2025
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

91319
Source: AWP
SARSCV2 VAC 10MCG TRS-SUC IM
HCPCS Dosage 0.3 ML
Units / Pkg 10

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0069-2501-10 identifies a specific commercial package of 10 vial, single-dose in 1 carton / .48 ml in 1 vial, single-dose (0069-2501-01) of Comirnaty, a vaccine label labeled by Pfizer Laboratories Div Pfizer Inc. This injection, suspension is formulated for intramuscular use and contains bnt162b2 omicron (lp.8.1) as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Pfizer Laboratories Div Pfizer Inc on August 27, 2025. The current certification is valid through December 31, 2027.

How is this Pfizer Laboratories Div Pfizer Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00069250110. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0069-2501-10
11-Digit CMS (5-4-2)
00069-2501-10

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.