Lansoprazole Tablet, Orally Disintegrating, Delayed Release
NDC Package 43598-561-78

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

Package Information

Lansoprazole tablets is lansoprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). This formulation utilizes a tablet, orally disintegrating, delayed release delivery system. Marketed by Dr.reddys Laboratories Inc, this product is identified by NDC 43598-561 and is authorized under FDA application ANDA210465.

Identification & Billing

NDC Package Code
43598-561-78
Package Description
100 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (43598-561-79)
Product Code
43598-561
11-Digit Billing Format
43598056178
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 351260 - lansoprazole 30 MG Delayed Release Disintegrating Oral Tablet
  • RxCUI: 351260 - lansoprazole 30 MG Disintegrating Oral Tablet
  • RxCUI: 351261 - lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet
  • RxCUI: 351261 - lansoprazole 15 MG Disintegrating Oral Tablet

Clinical Specifications

Proprietary Name
Lansoprazole
Non-Proprietary Name
Lansoprazole
Substance Name
Lansoprazole
Dosage Form
Tablet, Orally Disintegrating, Delayed Release - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue, but which releases a drug (or drugs) at a time other than promptly after administration.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LANSOPRAZOLE 30 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
Dr.reddys Laboratories Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA210465
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-01-2021
End Marketing Date
09-30-2026
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 43598-561-78 identifies a specific commercial package of 100 blister pack in 1 carton / 10 tablet, orally disintegrating, delayed release in 1 blister pack (43598-561-79) of Lansoprazole, a human prescription drug labeled by Dr.reddys Laboratories Inc. This tablet, orally disintegrating, 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.reddys Laboratories Inc on February 01, 2021.

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 Dr.reddys Laboratories Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43598056178. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
43598-561-78
11-Digit CMS (5-4-2)
43598-0561-78

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