Lansoprazole Capsule, Delayed Release
NDC Package 68196-045-03

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

Package Information

Lansoprazole capsules is lansoprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). This formulation utilizes a capsule, delayed release delivery system. Marketed by Sam's West Inc., this product is identified by NDC 68196-045 and is authorized under FDA application ANDA202194.

Identification & Billing

NDC Package Code
68196-045-03
Package Description
3 BOTTLE in 1 PACKAGE / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68196-045-01)
Product Code
68196-045
11-Digit Billing Format
68196004503
RxNorm Crosswalk
RxCUI: 596843 - lansoprazole 15 MG Delayed Release Oral Capsule

Clinical Specifications

Proprietary Name
Lansoprazole
Non-Proprietary Name
Lansoprazole
Substance Name
Lansoprazole
Dosage Form
Capsule, Delayed Release - 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, and which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LANSOPRAZOLE 15 mg/1
Pharmacologic Class
Usage Information
Lansoprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Lansoprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). If you are self-treating with this medication, over-the-counter lansoprazole products are used to treat frequent heartburn (occurring 2 or more days a week). Since it may take 1 to 4 days to have full effect, these products do not relieve heartburn right away. For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar brand names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Regulatory & Marketing

Labeler Name
Sam's West Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA202194
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-19-2019
Listing Expiration
12-31-2026
Exclude Flag
N
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 68196-045-03 identifies a specific commercial package of 3 bottle in 1 package / 14 capsule, delayed release in 1 bottle (68196-045-01) of Lansoprazole, a human over the counter drug labeled by Sam's West Inc.. This capsule, delayed release is formulated for oral use and contains lansoprazole as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Sam's West Inc. on August 19, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Lansoprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Lansoprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). If you are self-treating with this medication, over-the-counter lansoprazole products are used to treat frequent heartburn (occurring 2 or more days a week). Since it may take 1 to 4 days to have full effect, these products do not relieve heartburn right away. For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar brand names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

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: 68196004503. 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)
68196-045-03
11-Digit CMS (5-4-2)
68196-0045-03

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