NDC Package 0310-0482-30 Iressa

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

Package Information
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:

0310-0482-30

Package Description:

30 TABLET, COATED in 1 BOTTLE

Product Code:

0310-0482

Proprietary Name:

Iressa

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:

00310048230

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

RxCUI: 402091 - Iressa 250 MG Oral Tablet

RxCUI: 402091 - gefitinib 250 MG Oral Tablet [Iressa]

Product Type:

Human Prescription Drug

Labeler Name:

Astrazeneca Pharmaceuticals Lp

Dosage Form:

Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

Administration Route(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

GEFITINIB 250 mg/1

Pharmacologic Class(es):

Kinase Inhibitor - [EPC] (Established Pharmacologic Class)

Protein Kinase Inhibitors - [MoA] (Mechanism of Action)

Sample Package:

FDA Application Number:

NDA206995

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

07-13-2015

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

0310 - Astrazeneca Pharmaceuticals Lp
- 0310-0482 - Iressa
  - 0310-0482-30 - 30 TABLET, 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.

Frequently Asked Questions

What is NDC 0310-0482-30?

The NDC Packaged Code 0310-0482-30 is assigned to a package of 30 tablet, coated in 1 bottle of Iressa, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. The product's dosage form is tablet, 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 0310-0482 included in the NDC Directory?

Yes, Iressa with product code 0310-0482 is active and included in the NDC Directory. The product was first marketed by Astrazeneca Pharmaceuticals Lp on July 13, 2015 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0310-0482-30?

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 0310-0482-30?

The 11-digit format is 00310048230. 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	0310-0482-30	5-4-2	00310-0482-30

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