Gefitinib Tablet, Film Coated
NDC Package 0480-4053-56

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

Package Information

Gefitinib tablets is gefitinib is used to treat lung cancer. This formulation utilizes a tablet, film coated delivery system. Marketed by Teva Pharmaceuticals, Inc., this product is identified by NDC 0480-4053 and is authorized under FDA application ANDA208913.

Identification & Billing

NDC Package Code
0480-4053-56
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
0480-4053
11-Digit Billing Format
00480405356
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
RxCUI: 349472 - gefitinib 250 MG Oral Tablet

Clinical Specifications

Proprietary Name
Gefitinib
Non-Proprietary Name
Gefitinib
Substance Name
Gefitinib
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)
GEFITINIB 250 mg/1
Pharmacologic Class
Usage Information
Gefitinib is used to treat lung cancer. It works by slowing or stopping the growth of cancer cells. Gefitinib blocks a certain protein (an enzyme called tyrosine kinase).

Regulatory & Marketing

Labeler Name
Teva Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA208913
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-21-2023
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J8565
Source: PDAC
GEFITINIB, ORAL, 250 MG
HCPCS Dosage 250 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 0480-4053-56 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Gefitinib, a human prescription drug labeled by Teva Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This tablet, film coated is formulated for oral use and contains gefitinib 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 June 21, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Gefitinib is used to treat lung cancer. It works by slowing or stopping the growth of cancer cells. Gefitinib blocks a certain protein (an enzyme called tyrosine kinase).

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00480405356. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
0480-4053-56
11-Digit CMS (5-4-2)
00480-4053-56

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