Omeprazole And Sodium Bicarbonate
NDC Package 69665-216-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Omeprazole And Sodium Bicarbonate is  capsules is contraindicated in patients with known hypersensitivity to any components of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria. Marketed by Medarbor Llc, this product is identified by NDC 69665-216 and is authorized under FDA application ANDA204922.

Identification & Billing

NDC Package Code
69665-216-30
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
69665-216
11-Digit Billing Format
69665021630
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 616541 - omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule
  • RxCUI: 616541 - Omeprazole 40 MG / NaHCO3 1100 MG Oral Capsule

Clinical Specifications

Proprietary Name
Omeprazole And Sodium Bicarbonate
Dosage Form
-
Usage Information
Omeprazole and sodium bicarbonate capsules is contraindicated in patients with known hypersensitivity to any components of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria. [See Adverse Reactions (6)]

Regulatory & Marketing

Labeler Name
Medarbor Llc
FDA Application #
ANDA204922
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-01-2017
Listing Expiration
12-31-2025
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69665-216-30 identifies a specific commercial package of 30 capsule in 1 bottle of Omeprazole And Sodium Bicarbonate, labeled by Medarbor Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Medarbor Llc on July 01, 2017. The current certification is valid through December 31, 2025.

How is this Medarbor Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69665021630. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
69665-216-30
11-Digit CMS (5-4-2)
69665-0216-30

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.