Polymyxin B
NDC Package 47781-596-91

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.

Polymyxin B is a . Marketed by Alvogen Inc., this product is identified by NDC 47781-596 and is authorized under FDA application ANDA207322.

Identification & Billing

NDC Package Code
47781-596-91
Package Description
10 VIAL in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (47781-596-07)
Product Code
47781-596
11-Digit Billing Format
47781059691
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA

Clinical Specifications

Proprietary Name
Polymyxin B
Dosage Form
-

Regulatory & Marketing

Labeler Name
Alvogen Inc.
FDA Application #
ANDA207322
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-23-2017
End Marketing Date
05-01-2020
Listing Expiration
05-01-2020
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 47781-596-91 identifies a specific commercial package of 10 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial (47781-596-07) of Polymyxin B, labeled by Alvogen Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 10 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 Alvogen Inc. on September 23, 2017. The current certification is valid through May 01, 2020.

How is this Alvogen Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47781059691. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 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)
47781-596-91
11-Digit CMS (5-4-2)
47781-0596-91

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