Empagliflozin Tablet
NDC Package 49629-034-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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 tablets 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 tablet delivery system. Marketed by Rottendorf Pharma Gmbh, this product is identified by NDC 49629-034.

Identification & Billing

NDC Package Code
49629-034-01
Package Description
30 TABLET in 1 BOTTLE
Product Code
49629-034
11-Digit Billing Format
49629003401

Clinical Specifications

Proprietary Name
Empagliflozin
Non-Proprietary Name
Empagliflozin
Substance Name
Empagliflozin
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Active Ingredient(s)
EMPAGLIFLOZIN 25 mg/1
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
Rottendorf Pharma Gmbh
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
09-01-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (49629-034). Click a package code to view its specific billing and regulatory data.

49629-034-02
7 TABLET in 1 BOTTLE

* 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 49629-034-01 identifies a specific commercial package of 30 tablet in 1 bottle of Empagliflozin (UNFINISHED drug), drug for further processing labeled by Rottendorf Pharma Gmbh. This tablet 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 Rottendorf Pharma Gmbh on September 01, 2020. The current certification is valid through December 31, 2026.

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 Rottendorf Pharma Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49629003401. 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)
49629-034-01
11-Digit CMS (5-4-2)
49629-0034-01

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