Levothyroxine Sodium Injection, Powder, Lyophilized, For Solution
NDC Package 70511-112-10

11-digit billing NDC: 70511011210
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Levothyroxine Sodium (levothyroxine sodium anhydrous) injection is levothyroxine Sodium for Injection is indicated for the treatment of myxedema coma. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Maia Pharmaceuticals, Inc., this product is identified by NDC 70511-112 and is authorized under FDA application ANDA208749.

Identification & Billing

NDC Package Code
70511-112-10
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-USE
Product Code
70511-112
11-Digit Billing Format
70511011210
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Levothyroxine Sodium
Non-Proprietary Name
Levothyroxine Sodium Anhydrous
Substance Name
Levothyroxine Sodium Anhydrous
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
LEVOTHYROXINE SODIUM ANHYDROUS 200 ug/5mL
Pharmacologic Class
Usage Information
Levothyroxine Sodium for Injection is indicated for the treatment of myxedema coma. Important Limitations of Use: The relative bioavailability between Levothyroxine Sodium for Injection and oral levothyroxine products has not been established. Caution should be used when switching patients from oral levothyroxine products to Levothyroxine Sodium for Injection as accurate dosing conversion has not been studied.

Regulatory & Marketing

Labeler Name
Maia Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA208749
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-27-2018
Listing Expiration
12-31-2027
Exclude Flag
N
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70511-112-10 identifies a specific commercial package of 1 vial, single-use in 1 carton / 5 ml in 1 vial, single-use of Levothyroxine Sodium, a human prescription drug labeled by Maia Pharmaceuticals, Inc.. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains levothyroxine sodium anhydrous 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 Maia Pharmaceuticals, Inc. on December 27, 2018. The current certification is valid through December 31, 2027.

How is this Maia Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70511011210. 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)
70511-112-10
11-Digit CMS (5-4-2)
70511-0112-10

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