Relenza
NDC Package 54868-4377-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Relenza is zanamivir is used to treat symptoms caused by the flu virus (influenza) if you have had symptoms for 2 days or less. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4377 and is authorized under FDA application NDA021036.

Identification & Billing

NDC Package Code
54868-4377-0
Package Description
5 PACKAGE in 1 CARTON / 4 POWDER in 1 PACKAGE
Product Code
11-Digit Billing Format
54868437700
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
5 EA
RxNorm Crosswalk
  • RxCUI: 759471 - zanamivir 5 MG/INHAL Dry Powder Inhaler, 20 Blisters
  • RxCUI: 759471 - 20 ACTUAT zanamivir 5 MG/ACTUAT Dry Powder Inhaler
  • RxCUI: 759471 - zanamivir 5 MG/ACTUAT Dry Powder Inhaler, 20 ACTUAT
  • RxCUI: 759473 - RELENZA DISKHALER 5 MG/INHAL Dry Powder Inhaler, 20 Blisters
  • RxCUI: 759473 - 20 ACTUAT zanamivir 5 MG/ACTUAT Dry Powder Inhaler [Relenza]

Clinical Specifications

Proprietary Name
Relenza
Dosage Form
-
Usage Information
Zanamivir is used to treat symptoms caused by the flu virus (influenza) if you have had symptoms for 2 days or less. It helps lessen symptoms (such as stuffy nose, cough, sore throat, fever/chills, headache, body aches, tiredness) and shortens the recovery time by about 1 to 2 days. Zanamivir may also be used to prevent the flu if you have been exposed to someone who already has the flu (such as a sick household member) or if there is a flu outbreak in the community. Talk to your doctor for more details. This medication works by stopping the flu virus from growing. It is not a substitute for the flu vaccine. If you have the flu, zanamivir does not reduce the risk of giving the flu to others.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA021036
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-20-2009
Listing Expiration
12-31-2017
Exclude Flag
I
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54868-4377-0 identifies a specific commercial package of 5 package in 1 carton / 4 powder in 1 package of Relenza, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 5 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Physicians Total Care, Inc. on January 20, 2009. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

Zanamivir is used to treat symptoms caused by the flu virus (influenza) if you have had symptoms for 2 days or less. It helps lessen symptoms (such as stuffy nose, cough, sore throat, fever/chills, headache, body aches, tiredness) and shortens the recovery time by about 1 to 2 days. Zanamivir may also be used to prevent the flu if you have been exposed to someone who already has the flu (such as a sick household member) or if there is a flu outbreak in the community. Talk to your doctor for more details. This medication works by stopping the flu virus from growing. It is not a substitute for the flu vaccine. If you have the flu, zanamivir does not reduce the risk of giving the flu to others.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868437700. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 5 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 (5-4-1)
54868-4377-0
11-Digit CMS (5-4-2)
54868-4377-00

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