NDC Package 0409-1593-04 Tham

Tromethamine Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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:
Proprietary Name:
Tham
Non-Proprietary Name:
Tromethamine
Substance Name:
Tromethamine
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.
11-Digit NDC Billing Format:
00409159304
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 198412 - THAM 36 MG/ML in 500 ML Injection
  • RxCUI: 198412 - 500 ML tromethamine 36 MG/ML Injection
  • RxCUI: 198412 - tromethamine 18 GM per 500 ML Injection
  • RxCUI: 198412 - tromethamine 3.6 GM per 100 ML Injection
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hospira, Inc.
    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(s):
  • Intravenous - Administration within or into a vein or veins.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    NDA013025
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    06-24-2020
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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.

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    Frequently Asked Questions

    What is NDC 0409-1593-04?

    The NDC Packaged Code 0409-1593-04 is assigned to a 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.. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 0409-1593 included in the NDC Directory?

    Yes, Tham with product code 0409-1593 is active and included in the NDC Directory. The product was first marketed by Hospira, Inc. on June 24, 2020 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0409-1593-04?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0409-1593-04?

    The 11-digit format is 00409159304. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20409-1593-045-4-200409-1593-04