Tham Injection, Solution
NDC Package 0409-1593-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Tham (tromethamine) injection is tham Solution (tromethamine injection) is indicated for the prevention and correction of metabolic acidosis. This formulation utilizes a injection, solution delivery system. Marketed by Hospira, Inc., this product is identified by NDC 0409-1593 and is authorized under FDA application NDA013025.

Identification & Billing

NDC Package Code
0409-1593-04
Package Description
6 BOTTLE, GLASS in 1 CASE / 500 mL in 1 BOTTLE, GLASS (0409-1593-14)
Product Code
0409-1593
11-Digit Billing Format
00409159304
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tham
Non-Proprietary Name
Tromethamine
Substance Name
Tromethamine
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
TROMETHAMINE 3.6 g/100mL
Usage Information
Tham Solution (tromethamine injection) is indicated for the prevention and correction of metabolic acidosis. In the following conditions it may help to sustain vital functions and thus provide time for treatment of the primary disease:Metabolic Acidosis Associated with Cardiac Bypass Surgery.Tham Solution has been found to be primarily beneficial in correcting metabolic acidosis which may occur during or immediately following cardiac bypass surgical procedures.Correction of Acidity of ACD Blood in Cardiac Bypass Surgery.It is well known that ACD blood is acidic and becomes more acidic on storage. Tromethamine effectively corrects this acidity. Tham Solution may be added directly to the blood used to prime the pump-oxygenator. When ACD blood is brought to a normal pH range the patient is spared an initial acid load. Additional tromethamine may be indicated during cardiac bypass surgery should metabolic acidosis appear.Metabolic Acidosis Associated with Cardiac Arrest.Acidosis is nearly always one of the consequences of cardiac arrest and, in some instances, may even be a causative factor in arrest. It is important therefore, that the correction of acidosis should be started promptly with other resuscitative efforts. By correcting acidosis, Tham Solution (tromethamine injection) has caused the arrested heart to respond to resuscitative efforts after standard methods alone had failed. In these cases, tromethamine was given intraventricularly. It is to be noted, however, that such precariously ill patients often have died subsequently of causes unrelated to the administration of tromethamine. With administration by the peripheral venous route, metabolic acidosis has been corrected in a majority of patients. The success in reinstitution of cardiac rhythm by this means probably has not been of the same order of magnitude as with the intraventricular route.

Regulatory & Marketing

Labeler Name
Hospira, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA013025
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-24-2020
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 0409-1593-04 identifies a specific commercial package of 6 bottle, glass in 1 case / 500 ml in 1 bottle, glass (0409-1593-14) of Tham, a human prescription drug labeled by Hospira, Inc.. This injection, solution is formulated for intravenous use and contains tromethamine 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 Hospira, Inc. on June 24, 2020. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00409159304. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (4-4-2)
0409-1593-04
11-Digit CMS (5-4-2)
00409-1593-04

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