Synthroid
NDC Package 54868-1012-2
Package Information
Synthroid is levothyroxine is used to treat an underactive thyroid (hypothyroidism). Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-1012 and is authorized under FDA application NDA021402.
Identification & Billing
- RxCUI: 892246 - levothyroxine sodium 100 MCG Oral Tablet
- RxCUI: 892246 - levothyroxine sodium 0.1 MG Oral Tablet
- RxCUI: 892251 - levothyroxine sodium 200 MCG Oral Tablet
- RxCUI: 892251 - levothyroxine sodium 0.2 MG Oral Tablet
- RxCUI: 892255 - levothyroxine sodium 300 MCG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 54868 - Physicians Total Care, Inc.
- 54868-1012 - Synthroid
- 54868-1012-2 - 90 TABLET in 1 BOTTLE
- 54868-1012 - Synthroid
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 (54868-1012). Click a package code to view its specific billing and regulatory data.
* 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 54868-1012-2 identifies a specific commercial package of 90 tablet in 1 bottle of Synthroid, labeled by Physicians Total Care, 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 Physicians Total Care, Inc. on May 24, 1995. The current certification is valid through June 30, 2013.
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 Physicians Total Care, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868101202. 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:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.
