Levothroxine Sodium Powder
NDC Package 46014-1013-1

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.

Levothroxine Sodium powders is levothyroxine is used to treat an underactive thyroid (hypothyroidism). This formulation utilizes a powder delivery system. Marketed by Excella Gmbh & Co. Kg, this product is identified by NDC 46014-1013.

Identification & Billing

NDC Package Code
46014-1013-1
Package Description
50 kg in 1 DRUM
Product Code
46014-1013
11-Digit Billing Format
46014101301

Clinical Specifications

Proprietary Name
Levothroxine Sodium
Non-Proprietary Name
Levothroxine Sodium
Substance Name
Levothyroxine Sodium
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)
LEVOTHYROXINE SODIUM 1 kg/kg
Usage Information
Levothyroxine is used to treat an underactive thyroid (hypothyroidism). It replaces or provides more thyroid hormone, which is normally produced by the thyroid gland. Low thyroid hormone levels can occur naturally or when the thyroid gland is injured by radiation/medications or removed by surgery. Having enough thyroid hormone is important for maintaining normal mental and physical activity. In children, having enough thyroid hormone is important for normal mental and physical development. This medication is also used to treat other types of thyroid disorders (such as certain types of goiters, thyroid cancer). This medication should not be used to treat infertility unless it is caused by low thyroid hormone levels.

Regulatory & Marketing

Labeler Name
Excella Gmbh & Co. Kg
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
10-20-2011
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 46014-1013-1 identifies a specific commercial package of 50 kg in 1 drum of Levothroxine Sodium (UNFINISHED drug), a bulk ingredient labeled by Excella Gmbh & Co. Kg. This powder is formulated for use and contains levothyroxine sodium 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 Excella Gmbh & Co. Kg on October 20, 2011. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Levothyroxine is used to treat an underactive thyroid (hypothyroidism). It replaces or provides more thyroid hormone, which is normally produced by the thyroid gland. Low thyroid hormone levels can occur naturally or when the thyroid gland is injured by radiation/medications or removed by surgery. Having enough thyroid hormone is important for maintaining normal mental and physical activity. In children, having enough thyroid hormone is important for normal mental and physical development. This medication is also used to treat other types of thyroid disorders (such as certain types of goiters, thyroid cancer). This medication should not be used to treat infertility unless it is caused by low thyroid hormone levels.

How is this Excella Gmbh & Co. Kg product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46014101301. 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 (5-4-1)
46014-1013-1
11-Digit CMS (5-4-2)
46014-1013-01

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