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  5. NDC Package Code: 68382-501-10 Omeprazole And Sodium Bicarbonate

NDC Package 68382-501-10 Omeprazole And Sodium Bicarbonate

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 data was discontinued by the firm.

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:
68382-501-10
Package Description:
1000 CAPSULE in 1 BOTTLE
Product Code:
68382-501
Proprietary Name:
Omeprazole And Sodium Bicarbonate
Usage Information:
Omeprazole and Sodium bicarbonate capsules are indicated in adults for the: short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.short-term treatment (4 to 8 weeks) of active benign gastric ulcer.treatment of heartburn and other symptoms associated with GERD for up to 4 weeks.short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults.The efficacy of omeprazole and sodium bicarbonate capsules used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole and sodium bicarbonate capsules may be considered.maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months.
11-Digit NDC Billing Format:
68382050110
Labeler Name:
Zydus Pharmaceuticals Usa Inc.
Sample Package:
No
FDA Application Number:
ANDA203290
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
05-29-2018
End Marketing Date:
04-29-2025
Listing Expiration Date:
04-29-2025
Exclude Flag:
D
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
68382-501-01100 CAPSULE in 1 BOTTLE
68382-501-05500 CAPSULE in 1 BOTTLE
68382-501-0630 CAPSULE in 1 BOTTLE
68382-501-1690 CAPSULE in 1 BOTTLE
68382-501-6714 CAPSULE in 1 BOTTLE
68382-501-7710 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK (68382-501-30)

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 68382-501-10?

The NDC Packaged Code 68382-501-10 is assigned to a package of 1000 capsule in 1 bottle of Omeprazole And Sodium Bicarbonate, labeled by Zydus Pharmaceuticals Usa Inc.. The product's dosage form is and is administered via form.

Is NDC 68382-501 included in the NDC Directory?

No, Omeprazole And Sodium Bicarbonate with product code 68382-501 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Zydus Pharmaceuticals Usa Inc. on May 29, 2018 and its listing in the NDC Directory is set to expire on April 29, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 68382-501-10?

The 11-digit format is 68382050110. 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
5-3-268382-501-105-4-268382-0501-10