Levothyroxine Sodium
NDC Package 43602-421-10

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Levothyroxine Sodium is levothyroxine is used to treat an underactive thyroid (hypothyroidism). Marketed by Ascent Pharmaceuticals, Inc, this product is identified by NDC 43602-421 and is authorized under FDA application ANDA215259.

Identification & Billing

NDC Package Code
43602-421-10
Package Description
1000 TABLET in 1 BOTTLE
Product Code
43602-421
11-Digit Billing Format
43602042110

Clinical Specifications

Proprietary Name
Levothyroxine Sodium
Dosage Form
-
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
Ascent Pharmaceuticals, Inc
FDA Application #
ANDA215259
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-18-2023
End Marketing Date
01-19-2023
Listing Expiration
01-19-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (43602-421). Click a package code to view its specific billing and regulatory data.

43602-421-30
30 TABLET in 1 BOTTLE
43602-421-90
90 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 43602-421-10 identifies a specific commercial package of 1000 tablet in 1 bottle of Levothyroxine Sodium, labeled by Ascent Pharmaceuticals, Inc. 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 Ascent Pharmaceuticals, Inc on January 18, 2023. The current certification is valid through January 19, 2023.

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 Ascent Pharmaceuticals, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43602042110. 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)
43602-421-10
11-Digit CMS (5-4-2)
43602-0421-10

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