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  5. NDC Package Code: 68382-503-04 Omeprazole And Sodium Bicarbonate

NDC Package 68382-503-04 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:
68382-503-04
Package Description:
3 BOTTLE in 1 CARTON / 14 CAPSULE in 1 BOTTLE
Product Code:
68382-503
Proprietary Name:
Omeprazole And Sodium Bicarbonate
Non-Proprietary Name:
Omeprazole And Sodium Bicarbonate
Substance Name:
Omeprazole; Sodium Bicarbonate
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, although some people get complete relief of symptoms within 24 hours
11-Digit NDC Billing Format:
68382050304
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
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Zydus Pharmaceuticals Usa 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:
    ANDA203345
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-19-2018
    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
    68382-503-172 BOTTLE in 1 CARTON / 14 CAPSULE in 1 BOTTLE
    68382-503-671 BOTTLE in 1 CARTON / 14 CAPSULE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68382-503-04?

    The NDC Packaged Code 68382-503-04 is assigned to a package of 3 bottle in 1 carton / 14 capsule in 1 bottle of Omeprazole And Sodium Bicarbonate, a human over the counter drug labeled by Zydus Pharmaceuticals Usa Inc.. The product's dosage form is capsule and is administered via oral form.

    Is NDC 68382-503 included in the NDC Directory?

    Yes, Omeprazole And Sodium Bicarbonate with product code 68382-503 is active and included in the NDC Directory. The product was first marketed by Zydus Pharmaceuticals Usa Inc. on July 19, 2018 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 68382-503-04?

    The 11-digit format is 68382050304. 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
    5-3-268382-503-045-4-268382-0503-04