Gefitinib Tablet, Coated
NDC Package 67184-0531-2

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

Package Information

Gefitinib tablets is gefitinib is used to treat lung cancer. This formulation utilizes a tablet, coated delivery system. Marketed by Qilu Pharmaceutical Co., Ltd., this product is identified by NDC 67184-0531 and is authorized under FDA application ANDA211591.

Identification & Billing

NDC Package Code
67184-0531-2
Package Description
500 TABLET, COATED in 1 BOTTLE
Product Code
67184-0531
11-Digit Billing Format
67184053102
RxNorm Crosswalk
RxCUI: 349472 - gefitinib 250 MG Oral Tablet

Clinical Specifications

Proprietary Name
Gefitinib
Non-Proprietary Name
Gefitinib
Substance Name
Gefitinib
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
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
Qilu Pharmaceutical Co., Ltd.
Product Type
Human Prescription Drug
FDA Application #
ANDA211591
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-13-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (67184-0531). Click a package code to view its specific billing and regulatory data.

67184-0531-1
30 TABLET, COATED in 1 BOTTLE
67184-0531-3
3 BLISTER PACK in 1 CARTON / 10 TABLET, COATED in 1 BLISTER PACK

* 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 67184-0531-2 identifies a specific commercial package of 500 tablet, coated in 1 bottle of Gefitinib, a human prescription drug labeled by Qilu Pharmaceutical Co., Ltd.. This tablet, 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 Qilu Pharmaceutical Co., Ltd. on February 13, 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 Qilu Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67184053102. 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 (5-4-1)
67184-0531-2
11-Digit CMS (5-4-2)
67184-0531-02

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