Winrho
NDC Package 53270-3000-1

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Winrho is a . Marketed by Cangene Biopharma, Llc, this product is identified by NDC 53270-3000 and is authorized under FDA application BLA103649.

Identification & Billing

NDC Package Code
53270-3000-1
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 13 mL in 1 VIAL, SINGLE-DOSE
Product Code
53270-3000
11-Digit Billing Format
53270300001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Winrho
Dosage Form
-

Regulatory & Marketing

Labeler Name
Cangene Biopharma, Llc
FDA Application #
BLA103649
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-31-2005
End Marketing Date
02-28-2018
Listing Expiration
02-28-2018
Exclude Flag
D
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 53270-3000-1 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 13 ml in 1 vial, single-dose of Winrho, labeled by Cangene Biopharma, Llc. 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 Cangene Biopharma, Llc on March 31, 2005. The current certification is valid through February 28, 2018.

How is this Cangene Biopharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53270300001. 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 (5-4-1)
53270-3000-1
11-Digit CMS (5-4-2)
53270-3000-01

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