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  5. NDC Package Code: 50228-363-05 Omeprazole And Sodium Bicarbonate

NDC Package 50228-363-05 Omeprazole And Sodium Bicarbonate

Capsule Oral - 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:
50228-363-05
Package Description:
500 CAPSULE in 1 BOTTLE
Product Code:
50228-363
Proprietary Name:
Omeprazole And Sodium Bicarbonate
Non-Proprietary Name:
Omeprazole And Sodium Bicarbonate
Substance Name:
Omeprazole; 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 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 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:
50228036305
NDC to RxNorm Crosswalk:
  • RxCUI: 616539 - omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule
  • RxCUI: 616539 - Omeprazole 20 MG / NaHCO3 1100 MG Oral Capsule
  • RxCUI: 616541 - omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule
  • RxCUI: 616541 - Omeprazole 40 MG / NaHCO3 1100 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sciegen Pharmaceuticals, Inc.
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • OMEPRAZOLE 20 mg/1
  • SODIUM BICARBONATE 1100 mg/1
    • Pharmacologic Class(es):
  • Alkalinizing Activity - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C19 Inhibitors - [MoA] (Mechanism of Action)
  • Proton Pump Inhibitor - [EPC] (Established Pharmacologic Class)
  • Proton Pump Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA207476
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-06-2016
    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
    50228-363-3030 CAPSULE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50228-363-05?

    The NDC Packaged Code 50228-363-05 is assigned to a package of 500 capsule in 1 bottle of Omeprazole And Sodium Bicarbonate, a human prescription drug labeled by Sciegen Pharmaceuticals, Inc.. The product's dosage form is capsule and is administered via oral form.

    Is NDC 50228-363 included in the NDC Directory?

    Yes, Omeprazole And Sodium Bicarbonate with product code 50228-363 is active and included in the NDC Directory. The product was first marketed by Sciegen Pharmaceuticals, Inc. on December 06, 2016 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 50228-363-05?

    The 11-digit format is 50228036305. 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
    5-3-250228-363-055-4-250228-0363-05