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  5. NDC Package Code: 69367-195-30 Omeprazole/bicarbonate

NDC Package 69367-195-30 Omeprazole/bicarbonate

Omeprazole And Sodium Bicarbonate Capsule, Gelatin Coated 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:
69367-195-30
Package Description:
30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC
Product Code:
69367-195
Proprietary Name:
Omeprazole/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:
69367019530
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
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:
    Westminster Pharmaceuticals, Llc
    Dosage Form:
    Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
    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:
    07-27-2018
    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.

    Frequently Asked Questions

    What is NDC 69367-195-30?

    The NDC Packaged Code 69367-195-30 is assigned to a package of 30 capsule, gelatin coated in 1 bottle, plastic of Omeprazole/bicarbonate, a human prescription drug labeled by Westminster Pharmaceuticals, Llc. The product's dosage form is capsule, gelatin coated and is administered via oral form.

    Is NDC 69367-195 included in the NDC Directory?

    Yes, Omeprazole/bicarbonate with product code 69367-195 is active and included in the NDC Directory. The product was first marketed by Westminster Pharmaceuticals, Llc on July 27, 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 NDC billing unit for package 69367-195-30?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 69367-195-30?

    The 11-digit format is 69367019530. 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
    5-3-269367-195-305-4-269367-0195-30