Lapatinib Tablet
NDC Package 68180-801-36

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

Package Information

Lapatinib tablets is lapatinib is used to treat a certain type of breast cancer (HER2-positive). This formulation utilizes a tablet delivery system. Marketed by Lupin Pharmaceuticals, Inc., this product is identified by NDC 68180-801 and is authorized under FDA application ANDA203007.

Identification & Billing

NDC Package Code
68180-801-36
Package Description
150 TABLET in 1 BOTTLE
Product Code
68180-801
11-Digit Billing Format
68180080136
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lapatinib
Non-Proprietary Name
Lapatinib
Substance Name
Lapatinib Ditosylate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LAPATINIB DITOSYLATE 250 mg/1
Pharmacologic Class
Usage Information
Lapatinib is used to treat a certain type of breast cancer (HER2-positive). It works by slowing or stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Lupin Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA203007
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-29-2020
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 68180-801-36 identifies a specific commercial package of 150 tablet in 1 bottle of Lapatinib, a human prescription drug labeled by Lupin Pharmaceuticals, Inc.. This tablet is formulated for oral use and contains lapatinib ditosylate 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 Lupin Pharmaceuticals, Inc. on September 29, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Lapatinib is used to treat a certain type of breast cancer (HER2-positive). It works by slowing or stopping the growth of cancer cells.

How is this Lupin Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68180080136. 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)
68180-801-36
11-Digit CMS (5-4-2)
68180-0801-36

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