Lansoprazole
NDC Package 68196-075-03

11-digit billing NDC: 68196007503
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.

Lansoprazole is adults 18 years of age and olderthis product is to be used once a day (every 24 hours), every day for 14 daysit may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatmentswallow 1 capsule with a glass of water before eating in the morningtake every day for 14 daysdo not take more than 1 capsule a dayswallow whole. Marketed by Sam's West Inc., this product is identified by NDC 68196-075 and is authorized under FDA application ANDA202194.

Identification & Billing

NDC Package Code
68196-075-03
Package Description
3 BOTTLE in 1 PACKAGE / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68196-075-01)
Product Code
68196-075
11-Digit Billing Format
68196007503
RxNorm Crosswalk
RxCUI: 596843 - lansoprazole 15 MG Delayed Release Oral Capsule

Clinical Specifications

Proprietary Name
Lansoprazole
Dosage Form
-
Usage Information
Adults 18 years of age and olderthis product is to be used once a day (every 24 hours), every day for 14 daysit may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatmentswallow 1 capsule with a glass of water before eating in the morningtake every day for 14 daysdo not take more than 1 capsule a dayswallow whole. Do not crush or chew capsules.do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)you may repeat a 14-day course every 4 monthsdo not take for more than 14 days or more often than every 4 months unless directed by a doctorchildren under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.

Regulatory & Marketing

Labeler Name
Sam's West Inc.
FDA Application #
ANDA202194
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-12-2022
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 68196-075-03 identifies a specific commercial package of 3 bottle in 1 package / 14 capsule, delayed release in 1 bottle (68196-075-01) of Lansoprazole, labeled by Sam's West Inc.. 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 Sam's West Inc. on April 12, 2022. The current certification is valid through December 31, 2025.

How is this Sam's West Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68196007503. 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)
68196-075-03
11-Digit CMS (5-4-2)
68196-0075-03

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