Pentoxifylline Tablet, Extended Release
NDC Package 60505-0033-9

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

Pentoxifylline tablets is a medication used to improve the symptoms of a certain blood flow problem in the legs/arms (intermittent claudication due to occlusive artery disease). This formulation utilizes a tablet, extended release delivery system. Marketed by Apotex Corp., this product is identified by NDC 60505-0033 and is authorized under FDA application ANDA075191.

Identification & Billing

NDC Package Code
60505-0033-9
Package Description
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
60505-0033
11-Digit Billing Format
60505003309
RxNorm Crosswalk
RxCUI: 312301 - pentoxifylline 400 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Pentoxifylline
Non-Proprietary Name
Pentoxifylline
Substance Name
Pentoxifylline
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PENTOXIFYLLINE 400 mg/1
Pharmacologic Class
Usage Information
This medication is used to improve the symptoms of a certain blood flow problem in the legs/arms (intermittent claudication due to occlusive artery disease). Pentoxifylline can decrease the muscle aching/pain/cramps during exercise, including walking, that occur with intermittent claudication. Pentoxifylline belongs to a class of drugs known as hemorrheologic agents. It works by helping blood flow more easily through narrowed arteries. This increases the amount of oxygen that can be delivered by the blood when the muscles need more (such as during exercise) thereby increasing walking distance and duration.

Regulatory & Marketing

Labeler Name
Apotex Corp.
Product Type
Human Prescription Drug
FDA Application #
ANDA075191
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-10-1999
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 (60505-0033). Click a package code to view its specific billing and regulatory data.

60505-0033-6
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
60505-0033-7
500 TABLET, EXTENDED RELEASE in 1 BOTTLE
60505-0033-8
5500 TABLET, EXTENDED RELEASE in 1 BOTTLE

* 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 60505-0033-9 identifies a specific commercial package of 1000 tablet, extended release in 1 bottle of Pentoxifylline, a human prescription drug labeled by Apotex Corp.. This tablet, extended release is formulated for oral use and contains pentoxifylline 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 Apotex Corp. on June 10, 1999. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to improve the symptoms of a certain blood flow problem in the legs/arms (intermittent claudication due to occlusive artery disease). Pentoxifylline can decrease the muscle aching/pain/cramps during exercise, including walking, that occur with intermittent claudication. Pentoxifylline belongs to a class of drugs known as hemorrheologic agents. It works by helping blood flow more easily through narrowed arteries. This increases the amount of oxygen that can be delivered by the blood when the muscles need more (such as during exercise) thereby increasing walking distance and duration.

How is this Apotex Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60505003309. 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)
60505-0033-9
11-Digit CMS (5-4-2)
60505-0033-09

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