Zaroxolyn
NDC Package 53014-975-71

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.

Zaroxolyn is a . Marketed by Unither Manufacturing Llc, this product is identified by NDC 53014-975 and is authorized under FDA application NDA017386.

Identification & Billing

NDC Package Code
53014-975-71
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
53014-975
11-Digit Billing Format
53014097571
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Zaroxolyn
Dosage Form
-

Regulatory & Marketing

Labeler Name
Unither Manufacturing Llc
FDA Application #
NDA017386
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-27-1973
End Marketing Date
04-30-2015
Listing Expiration
04-30-2015
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 53014-975-71 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Zaroxolyn, labeled by Unither Manufacturing Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 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 Unither Manufacturing Llc on November 27, 1973. The current certification is valid through April 30, 2015.

How is this Unither Manufacturing Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53014097571. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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 (5-3-2)
53014-975-71
11-Digit CMS (5-4-2)
53014-0975-71

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