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  5. NDC Package Code: 53041-690-03 Diatrizoate Meglumine And Diatrizoate Sodium

NDC Package 53041-690-03 Diatrizoate Meglumine And Diatrizoate Sodium

Solution Oral; Rectal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

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:
53041-690-03
Package Description:
120 mL in 1 BOTTLE, GLASS
Product Code:
53041-690
Proprietary Name:
Diatrizoate Meglumine And Diatrizoate Sodium
Non-Proprietary Name:
Diatrizoate Meglumine And Diatrizoate Sodium
Substance Name:
Diatrizoate Meglumine; Diatrizoate Sodium
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.
11-Digit NDC Billing Format:
53041069003
Product Type:
Human Prescription Drug
Labeler Name:
Guardian Drug Company
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(s):
  • Oral - Administration to or by way of the mouth.
  • Rectal - Administration to the rectum.
    • Active Ingredient(s):
  • DIATRIZOATE MEGLUMINE 660 mg/mL
  • DIATRIZOATE SODIUM 100 mg/mL
    • Pharmacologic Class(es):
  • Radiographic Contrast Agent - [EPC] (Established Pharmacologic Class)
  • Radiographic Contrast Agent - [EPC] (Established Pharmacologic Class)
  • X-Ray Contrast Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA214201
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-18-2019
    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.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    53041-690-0930 mL in 1 BOTTLE, GLASS

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53041-690-03?

    The NDC Packaged Code 53041-690-03 is assigned to a package of 120 ml in 1 bottle, glass of Diatrizoate Meglumine And Diatrizoate Sodium, a human prescription drug labeled by Guardian Drug Company. The product's dosage form is solution and is administered via oral; rectal form.

    Is NDC 53041-690 included in the NDC Directory?

    Yes, Diatrizoate Meglumine And Diatrizoate Sodium with product code 53041-690 is active and included in the NDC Directory. The product was first marketed by Guardian Drug Company on December 18, 2019 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 11-digit format for NDC 53041-690-03?

    The 11-digit format is 53041069003. 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 5-3-2 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
    5-3-253041-690-035-4-253041-0690-03