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  5. NDC Package Code: 59368-325-01 Topcare Omeprazole Delayed Release

NDC Package 59368-325-01 Topcare Omeprazole Delayed Release

View Billable Units, 11-Digit Format, RxNorm

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 certification is expired.

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:
59368-325-01
Package Description:
1 BOTTLE in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code:
59368-325
Proprietary Name:
Topcare Omeprazole Delayed Release
Usage Information:
For adults 18 years of age and olderthis product is to be used once a day (every 24 hours), every day for 14 daysit may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours14-Day Course of Treatmentswallow 1 tablet with a glass of water before eating in the morningtake every day for 14 daysdo not take more than 1 tablet a daydo not use for more than 14 days unless directed by your doctorswallow whole. Do not chew, crush, or suck tablets.Repeated 14-Day Courses (if needed)you may repeat a 14-day course every 4 monthsdo not take for more than 14 days or more often than every 4 months unless directed by a doctorchildren under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.
11-Digit NDC Billing Format:
59368032501
NDC to RxNorm Crosswalk:
  • RxCUI: 402014 - omeprazole 20 MG Delayed Release Oral Tablet
  • RxCUI: 402014 - omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet
Labeler Name:
Praxis, Llc
Sample Package:
No
FDA Application Number:
NDA022032
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
02-02-2016
Listing Expiration Date:
12-31-2026
Exclude Flag:
E
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
59368-325-023 BOTTLE in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 59368-325-01?

The NDC Packaged Code 59368-325-01 is assigned to a package of 1 bottle in 1 carton / 14 tablet, delayed release in 1 bottle of Topcare Omeprazole Delayed Release, labeled by Praxis, Llc. The product's dosage form is and is administered via form.

Is NDC 59368-325 included in the NDC Directory?

No, Topcare Omeprazole Delayed Release with product code 59368-325 is excluded from the NDC Directory for failure to respond to FDA's requests for correction to deficient or non-compliant submissions. The product was first marketed by Praxis, Llc on February 02, 2016 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 59368-325-01?

The 11-digit format is 59368032501. 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
5-3-259368-325-015-4-259368-0325-01