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  4. NDC Product Code: 0069-2465 Abrysvo

NDC 0069-2465 Abrysvo

Respiratory Syncytial Virus Vaccine Injection, Powder, Lyophilized, For Solution - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0069-2465?
  4. Abrysvo Uses
  5. Active Ingredients
  6. NDC to RxNorm Crosswalk

Product Information

Get all the details for National Drug Code (NDC) 0069-2465 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
0069-2465
Proprietary Name:
Abrysvo
Non-Proprietary Name: [1]
Respiratory Syncytial Virus Vaccine
Substance Name: [2]
Recombinant Stabilized Rsv A Prefusion F Antigen; Recombinant Stabilized Rsv B Prefusion F Antigen
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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(s): [4]
Intramuscular - Administration within a muscle.
Labeler Name: [5]
Pfizer Laboratories Div Pfizer Inc
Labeler Code:
0069
Product Label ID:
be18292e-b1a2-4815-a0ed-003efaa6bea3
FDA Application Number: [6]
BLA125769
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
07-30-2024
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
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Product Details

What is NDC 0069-2465?

The NDC code 0069-2465 is assigned by the FDA to the product Abrysvo which is a vaccine label product labeled by Pfizer Laboratories Div Pfizer Inc. The generic name of Abrysvo is respiratory syncytial virus vaccine. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intramuscular form. The product is distributed in 2 packages with assigned NDC codes 0069-2465-01 1 vial in 1 carton / .5 ml in 1 vial (0069-2465-19), 0069-2465-10 10 vial in 1 carton / .5 ml in 1 vial (0069-2465-19). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Abrysvo?

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.

What are Abrysvo Active Ingredients?

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 Abrysvo?

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: 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]

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Product Footnotes

[1] 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.

[2] 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.

[3] 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.

[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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".