Azithromycin Powder
NDC Package 65427-310-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Azithromycin powders is a medication used to treat certain eye infections. This formulation utilizes a powder delivery system. Marketed by Viatris Pharmaceuticals Llc, this product is identified by NDC 65427-310.

Identification & Billing

NDC Package Code
65427-310-01
Package Description
100 kg in 1 DRUM
Product Code
65427-310
11-Digit Billing Format
65427031001

Clinical Specifications

Proprietary Name
Azithromycin
Non-Proprietary Name
Azithromycin
Substance Name
Azithromycin, Unspecified Form
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
AZITHROMYCIN, UNSPECIFIED FORM 1 kg/kg
Usage Information
This medication is used to treat certain eye infections. It is a macrolide antibiotic that works by stopping the growth of bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Viatris Pharmaceuticals Llc
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
04-08-2014
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 65427-310-01 identifies a specific commercial package of 100 kg in 1 drum of Azithromycin (UNFINISHED drug), a bulk ingredient labeled by Viatris Pharmaceuticals Llc. This powder is formulated for use and contains azithromycin, unspecified form as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Viatris Pharmaceuticals Llc on April 08, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat certain eye infections. It is a macrolide antibiotic that works by stopping the growth of bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

How is this Viatris Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65427031001. 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)
65427-310-01
11-Digit CMS (5-4-2)
65427-0310-01

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