Lansoprazole Capsule, Delayed Release
NDC Package 43598-161-33

11-digit billing NDC: 43598016133
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Lansoprazole capsules 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. This formulation utilizes a capsule, delayed release delivery system. Marketed by Dr. Reddy's Laboratories Inc., this product is identified by NDC 43598-161 and is authorized under FDA application ANDA202194.

Identification & Billing

NDC Package Code
43598-161-33
Package Description
3 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Product Code
43598-161
11-Digit Billing Format
43598016133
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
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 doctor Repeated 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
Dr. Reddy's Laboratories 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
10-01-2022
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (43598-161). Click a package code to view its specific billing and regulatory data.

43598-161-52
1 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

* 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 43598-161-33 identifies a specific commercial package of 3 bottle in 1 carton / 14 capsule, delayed release in 1 bottle of Lansoprazole, a human over the counter drug labeled by Dr. Reddy's Laboratories 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 Dr. Reddy's Laboratories Inc. on October 01, 2022. The current certification is valid through December 31, 2027.

How is this Dr. Reddy's Laboratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43598016133. 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)
43598-161-33
11-Digit CMS (5-4-2)
43598-0161-33

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