NDC Package 69367-195-30 Omeprazole/bicarbonate

View Billable Units, 11-Digit Format, RxNorm

Package Information
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:

69367-195-30

Package Description:

30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC

Product Code:

69367-195

Proprietary Name:

Omeprazole/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

Labeler Name:

Westminster Pharmaceuticals, Llc

Sample Package:

FDA Application Number:

ANDA207476

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

07-27-2018

End Marketing Date:

07-31-2025

Listing Expiration Date:

07-31-2025

Exclude Flag:

Code Structure:

69367 - Westminster Pharmaceuticals, Llc
- 69367-195 - Omeprazole/bicarbonate
  - 69367-195-30 - 30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC

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, labeled by Westminster Pharmaceuticals, Llc. The product's dosage form is and is administered via form.

Is NDC 69367-195 included in the NDC Directory?

No, Omeprazole/bicarbonate with product code 69367-195 is excluded from the NDC Directory because it was discontinued by the manufacturer. 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 July 31, 2025 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	69367-195-30	5-4-2	69367-0195-30

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