NDC Package 58160-848-11 Arexvy

Respiratory Syncytial Visus Vaccine Recombinant,Adjuvanted Kit - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

58160-848-11

Package Description:

1 KIT in 1 CARTON * .5 mL in 1 VIAL (58160-723-03) * .5 mL in 1 VIAL (58160-744-03)

Product Code:

58160-848

Proprietary Name:

Arexvy

Non-Proprietary Name:

Respiratory Syncytial Visus Vaccine Recombinant, Adjuvanted

Usage Information:

AREXVY is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in individuals 60 years of age and older.

11-Digit NDC Billing Format:

58160084811

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

RxCUI: 2636593 - respiratory syncytial virus pre-fusion F protein, recombinant 120 MCG per 0.5 ML Injection

RxCUI: 2636593 - 0.5 ML respiratory syncytial virus pre-fusion F protein, recombinant 0.24 MG/ML Injection

RxCUI: 2636599 - AREXVY 120 MCG per 0.5 ML Injection

RxCUI: 2636599 - 0.5 ML respiratory syncytial virus pre-fusion F protein, recombinant 0.24 MG/ML Injection [Arexvy]

RxCUI: 2636599 - 0.5 ML Arexvy 0.24 MG/ML Injection

Product Type:

Vaccine

Labeler Name:

Glaxosmithkline Biologicals Sa

Dosage Form:

Kit - A packaged collection of related material.

Sample Package:

FDA Application Number:

BLA125775

Marketing Category:

BLA - A product marketed under an approved Biologic License Application.

Start Marketing Date:

05-03-2023

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

58160 - Glaxosmithkline Biologicals Sa
- 58160-848 - Arexvy
  - 58160-848-11 - 1 KIT in 1 CARTON * .5 mL in 1 VIAL (58160-723-03) * .5 mL in 1 VIAL (58160-744-03)

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 disclaimer below.

Frequently Asked Questions

What is NDC 58160-848-11?

The NDC Packaged Code 58160-848-11 is assigned to a package of 1 kit in 1 carton * .5 ml in 1 vial (58160-723-03) * .5 ml in 1 vial (58160-744-03) of Arexvy, a vaccine label labeled by Glaxosmithkline Biologicals Sa. The product's dosage form is kit and is administered via form.

Is NDC 58160-848 included in the NDC Directory?

Yes, Arexvy with product code 58160-848 is active and included in the NDC Directory. The product was first marketed by Glaxosmithkline Biologicals Sa on May 03, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 58160-848-11?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

What is the 11-digit format for NDC 58160-848-11?

The 11-digit format is 58160084811. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	58160-848-11	5-4-2	58160-0848-11

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