Abrysvo Injection, Powder, Lyophilized, For Solution
NDC Package 0069-2465-01

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

Package Information

Abrysvo (respiratory syncytial virus vaccine) injection is aBRYSVO is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Pfizer Laboratories Div Pfizer Inc, this product is identified by NDC 0069-2465 and is authorized under FDA application BLA125769.

Identification & Billing

NDC Package Code
0069-2465-01
Package Description
1 VIAL in 1 CARTON / .5 mL in 1 VIAL (0069-2465-19)
Product Code
0069-2465
11-Digit Billing Format
00069246501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 2642142 - respiratory syncytial virus pre-fusion F protein, A, recombinant, stabilized 60 MCG / respiratory syncytial virus pre-fusion F protein, B, recombinant, stabilized 60 MCG in 0.5 ML Injection
  • RxCUI: 2642142 - 0.5 ML respiratory syncytial virus pre-fusion F protein, A, recombinant, stabilized 0.12 MG/ML / respiratory syncytial virus pre-fusion F protein, B, recombinant, stabilized 0.12 MG/ML Injection
  • RxCUI: 2642142 - respiratory syncytial virus pre-fusion F protein, A, recombinant, stabilized 60 MCG / respiratory syncytial virus pre-fusion F protein, B, recombinant, stabilized 60 MCG per 0.5 ML Injection
  • RxCUI: 2642148 - ABRYSVO 60 MCG / 60 MCG in 0.5 ML Injection
  • RxCUI: 2642148 - 0.5 ML respiratory syncytial virus pre-fusion F protein, A, recombinant, stabilized 0.12 MG/ML / respiratory syncytial virus pre-fusion F protein, B, recombinant, stabilized 0.12 MG/ML Injection [Abrysvo]

Clinical Specifications

Proprietary Name
Abrysvo
Non-Proprietary Name
Respiratory Syncytial Virus Vaccine
Substance Name
Recombinant Stabilized Rsv A Prefusion F Antigen; Recombinant Stabilized Rsv B Prefusion F Antigen
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
Usage Information
ABRYSVO is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older.

Regulatory & Marketing

Labeler Name
Pfizer Laboratories Div Pfizer Inc
Product Type
Vaccine
FDA Application #
BLA125769
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-30-2024
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0069-2465). Click a package code to view its specific billing and regulatory data.

0069-2465-10
10 VIAL in 1 CARTON / .5 mL in 1 VIAL (0069-2465-19)

* 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 0069-2465-01 identifies a specific commercial package of 1 vial in 1 carton / .5 ml in 1 vial (0069-2465-19) of Abrysvo, a vaccine label labeled by Pfizer Laboratories Div Pfizer Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intramuscular use and contains recombinant stabilized rsv a prefusion f antigen; recombinant stabilized rsv b prefusion f antigen 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 July 30, 2024. The current certification is valid through December 31, 2026.

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: 00069246501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
0069-2465-01
11-Digit CMS (5-4-2)
00069-2465-01

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