Empagliflozin Powder
NDC Package 33342-608-80

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.

Empagliflozin powders is empagliflozin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. This formulation utilizes a powder delivery system. Marketed by Macleods Pharmaceuticals Limited, this product is identified by NDC 33342-608.

Identification & Billing

NDC Package Code
33342-608-80
Package Description
15 kg in 1 CONTAINER
Product Code
33342-608
11-Digit Billing Format
33342060880

Clinical Specifications

Proprietary Name
Empagliflozin
Non-Proprietary Name
Empagliflozin
Substance Name
Empagliflozin
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)
EMPAGLIFLOZIN 15 kg/15kg
Usage Information
Empagliflozin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Empagliflozin is also used in patients with type 2 diabetes and heart disease to lower the risk of death from heart attack or stroke. Empagliflozin works by increasing the removal of sugar by your kidneys.

Regulatory & Marketing

Labeler Name
Macleods Pharmaceuticals Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
09-24-2024
Listing Expiration
12-31-2027
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 33342-608-80 identifies a specific commercial package of 15 kg in 1 container of Empagliflozin (UNFINISHED drug), a bulk ingredient labeled by Macleods Pharmaceuticals Limited. This powder is formulated for use and contains empagliflozin 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 Macleods Pharmaceuticals Limited on September 24, 2024. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Empagliflozin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Empagliflozin is also used in patients with type 2 diabetes and heart disease to lower the risk of death from heart attack or stroke. Empagliflozin works by increasing the removal of sugar by your kidneys.

How is this Macleods Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33342060880. 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)
33342-608-80
11-Digit CMS (5-4-2)
33342-0608-80

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