Omesec
NDC Package 16853-1308-2

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

Package Information

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

Omesec is a medication used as UseTreats frequent heartburn (occurs 2 or more days a week)Not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect. Marketed by Corporacion Infarmasa, this product is identified by NDC 16853-1308 and is authorized under FDA application ANDA075410.

Identification & Billing

NDC Package Code
16853-1308-2
Package Description
28 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
Product Code
16853-1308
11-Digit Billing Format
16853130802
RxNorm Crosswalk
  • RxCUI: 198051 - omeprazole 20 MG Delayed Release Oral Capsule
  • RxCUI: 198051 - omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule
  • RxCUI: 967525 - omeprazole 20 MG Delayed Release Oral Capsule [Omesec]
  • RxCUI: 967525 - Omesec 20 MG Delayed Release Oral Capsule

Clinical Specifications

Proprietary Name
Omesec
Dosage Form
-
Usage Information
This product is used as UseTreats frequent heartburn (occurs 2 or more days a week)Not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.

Regulatory & Marketing

Labeler Name
Corporacion Infarmasa
FDA Application #
ANDA075410
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-28-2010
Listing Expiration
12-31-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (16853-1308). Click a package code to view its specific billing and regulatory data.

16853-1308-1
14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
16853-1308-3
42 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
16853-1308-4
2 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK

* 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 16853-1308-2 identifies a specific commercial package of 28 capsule, delayed release in 1 blister pack of Omesec, labeled by Corporacion Infarmasa. 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 Corporacion Infarmasa on February 28, 2010. The current certification is valid through December 31, 2017.

How is this Corporacion Infarmasa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16853130802. 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 (5-4-1)
16853-1308-2
11-Digit CMS (5-4-2)
16853-1308-02

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