Oraltag
NDC Package 54702-501-98

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Oraltag is indicated for use in computed tomography of the abdomen and pelvis to opacify bowel loops and delineate between normal loops and adjacent organs or areas of suspected pathology.Limitations of UseOraltag is not indicated for diagnostic examination of the gastrointestinal tract. Marketed by Interpharma Praha, A.s., this product is identified by NDC 54702-501 and is authorized under FDA application NDA205383.

Identification & Billing

NDC Package Code
54702-501-98
Package Description
12 POUCH in 1 CASE / 1 BOTTLE, PLASTIC in 1 POUCH (54702-501-99) / 1 FOR SOLUTION in 1 BOTTLE, PLASTIC (54702-501-21)
Product Code
54702-501
11-Digit Billing Format
54702050198

Clinical Specifications

Proprietary Name
Oraltag
Dosage Form
-
Usage Information
Oraltag is indicated for use in computed tomography of the abdomen and pelvis to opacify bowel loops and delineate between normal loops and adjacent organs or areas of suspected pathology.Limitations of UseOraltag is not indicated for diagnostic examination of the gastrointestinal tract.

Regulatory & Marketing

Labeler Name
Interpharma Praha, A.s.
FDA Application #
NDA205383
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-01-2016
Listing Expiration
12-31-2024
Exclude Flag
I
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 (54702-501). Click a package code to view its specific billing and regulatory data.

54702-501-52
12 POUCH in 1 CASE / 1 BOTTLE, PLASTIC in 1 POUCH (54702-501-51) / 1 FOR SOLUTION in 1 BOTTLE, PLASTIC (54702-501-21)
54702-501-62
25 POUCH in 1 CASE / 1 BOTTLE, PLASTIC in 1 POUCH (54702-501-51) / 1 FOR SOLUTION in 1 BOTTLE, PLASTIC (54702-501-21)

* 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 54702-501-98 identifies a specific commercial package of 12 pouch in 1 case / 1 bottle, plastic in 1 pouch (54702-501-99) / 1 for solution in 1 bottle, plastic (54702-501-21) of Oraltag, labeled by Interpharma Praha, A.s.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Interpharma Praha, A.s. on July 01, 2016. The current certification is valid through December 31, 2024.

How is this Interpharma Praha, A.s. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54702050198. 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)
54702-501-98
11-Digit CMS (5-4-2)
54702-0501-98

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