Lapatinib Tablet, Film Coated
NDC Package 0480-3237-51

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, film coated delivery system. Marketed by Teva Pharmaceuticals, Inc., this product is identified by NDC 0480-3237 and is authorized under FDA application ANDA217968.

Identification & Billing

NDC Package Code
0480-3237-51
Package Description
150 TABLET, FILM COATED in 1 BOTTLE
Product Code
0480-3237
11-Digit Billing Format
00480323751
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
150 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lapatinib
Non-Proprietary Name
Lapatinib
Substance Name
Lapatinib Ditosylate
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
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
Teva Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA217968
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-19-2024
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 0480-3237-51 identifies a specific commercial package of 150 tablet, film coated in 1 bottle of Lapatinib, a human prescription drug labeled by Teva Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 150 billable units per package. This tablet, film coated 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 Teva Pharmaceuticals, Inc. on December 19, 2024. 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 Teva Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00480323751. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 150 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 (4-4-2)
0480-3237-51
11-Digit CMS (5-4-2)
00480-3237-51

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