Diatrizoate Meglumine And Diatrizoate Sodium Solution
NDC Package 53041-690-09

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

Diatrizoate Meglumine And Diatrizoate Sodium solution is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). This formulation utilizes a solution delivery system. Marketed by Guardian Drug Company, this product is identified by NDC 53041-690 and is authorized under FDA application ANDA214201.

Identification & Billing

NDC Package Code
53041-690-09
Package Description
30 mL in 1 BOTTLE, GLASS
Product Code
53041-690
11-Digit Billing Format
53041069009

Clinical Specifications

Proprietary Name
Diatrizoate Meglumine And Diatrizoate Sodium
Non-Proprietary Name
Diatrizoate Meglumine And Diatrizoate Sodium
Substance Name
Diatrizoate Meglumine; Diatrizoate Sodium
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
  • Oral - Administration to or by way of the mouth.
  • Rectal - Administration to the rectum.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Diatrizoate Meglumine and Diatrizoate Sodium Solution is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). The preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water-soluble, is not feasible or is potentially dangerous.Diatrizoate Meglumine and Diatrizoate Sodium Solution may also be used as an adjunct to contrast enhancement is computed tomography of the torso (body imaging); the preparation is indicated, in conjunction with intravenous administration of a radiopaque contrast agent, when unenhanced imaging may not provide sufficient definition in distinguishing normal loops of bowel from adjacent organs or areas of suspected pathology.

Regulatory & Marketing

Labeler Name
Guardian Drug Company
Product Type
Human Prescription Drug
FDA Application #
ANDA214201
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-18-2019
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (53041-690). Click a package code to view its specific billing and regulatory data.

53041-690-03
120 mL in 1 BOTTLE, GLASS

* 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 53041-690-09 identifies a specific commercial package of 30 ml in 1 bottle, glass of Diatrizoate Meglumine And Diatrizoate Sodium, a human prescription drug labeled by Guardian Drug Company. This solution is formulated for oral; rectal use and contains diatrizoate meglumine; diatrizoate sodium 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 Guardian Drug Company on December 18, 2019. The current certification is valid through December 31, 2026.

How is this Guardian Drug Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53041069009. 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)
53041-690-09
11-Digit CMS (5-4-2)
53041-0690-09

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