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  5. NDC Package Code: 53041-663-77 Omeprazole, Sodium Bicarbonate

NDC Package 53041-663-77 Omeprazole, Sodium Bicarbonate

Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
53041-663-77
Package Description:
30 CAPSULE in 1 BOTTLE
Product Code:
53041-663
Proprietary Name:
Omeprazole, Sodium Bicarbonate
Non-Proprietary Name:
Omeprazole, 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 capsules used for longer than 8 weeks in patient 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 no extend beyond 12 months
11-Digit NDC Billing Format:
53041066377
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:
    Guardian Drug Company
    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 40 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:
    ANDA212587
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-07-2020
    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.

    Frequently Asked Questions

    What is NDC 53041-663-77?

    The NDC Packaged Code 53041-663-77 is assigned to a package of 30 capsule in 1 bottle of Omeprazole, Sodium Bicarbonate, a human prescription drug labeled by Guardian Drug Company. The product's dosage form is capsule and is administered via oral form.

    Is NDC 53041-663 included in the NDC Directory?

    Yes, Omeprazole, Sodium Bicarbonate with product code 53041-663 is active and included in the NDC Directory. The product was first marketed by Guardian Drug Company on May 07, 2020 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 53041-663-77?

    The 11-digit format is 53041066377. 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
    5-3-253041-663-775-4-253041-0663-77