NDC Package 0480-4053-56 Gefitinib

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
NDC HCPCS Crosswalk
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

0480-4053-56

Package Description:

30 TABLET, FILM COATED in 1 BOTTLE

Product Code:

0480-4053

Proprietary Name:

Gefitinib

Non-Proprietary Name:

Gefitinib

Substance Name:

Gefitinib

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).

11-Digit NDC Billing Format:

00480405356

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

30 EA

NDC to RxNorm Crosswalk:

RxCUI: 349472 - gefitinib 250 MG Oral Tablet

Product Type:

Human Prescription Drug

Labeler Name:

Teva Pharmaceuticals, Inc.

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(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

GEFITINIB 250 mg/1

Pharmacologic Class(es):

Sample Package:

FDA Application Number:

ANDA208913

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

06-21-2023

Listing Expiration Date:

12-31-2025

Exclude Flag:

Code Structure:

0480 - Teva Pharmaceuticals, Inc.
- 0480-4053 - Gefitinib
  - 0480-4053-56 - 30 TABLET, FILM COATED in 1 BOTTLE

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 disclaimer below.

NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 0480-4053-56 HCPCS crosswalk information with package details and bill units information.

NDC Billing Code	HCPCS Code	HCPCS Code Desc.	Dosage	Package Size	Package Quantity	Billable Units	Billable Units / Pkg
00480405356	J8565	GEFITINIB, ORAL, 250 MG	250 MG	30		EA

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0480-4053-56?

The NDC Packaged Code 0480-4053-56 is assigned to a package of 30 tablet, film coated in 1 bottle of Gefitinib, a human prescription drug labeled by Teva Pharmaceuticals, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package.

Is NDC 0480-4053 included in the NDC Directory?

Yes, Gefitinib with product code 0480-4053 is active and included in the NDC Directory. The product was first marketed by Teva Pharmaceuticals, Inc. on June 21, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0480-4053-56?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

What is the 11-digit format for NDC 0480-4053-56?

The 11-digit format is 00480405356. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0480-4053-56	5-4-2	00480-4053-56

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