Pentoxifylline Tablet, Extended Release
NDC Package 0615-8511-39

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 Ncs Healthcare Of Ky, Llc Dba Vangard Labs, this product is identified by NDC 0615-8511 and is authorized under FDA application ANDA074878.

Identification & Billing

NDC Package Code
0615-8511-39
Package Description
30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
0615-8511
11-Digit Billing Format
00615851139
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
Ncs Healthcare Of Ky, Llc Dba Vangard Labs
Product Type
Human Prescription Drug
FDA Application #
ANDA074878
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-15-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0615-8511-39 identifies a specific commercial package of 30 tablet, extended release in 1 blister pack of Pentoxifylline, a human prescription drug labeled by Ncs Healthcare Of Ky, Llc Dba Vangard Labs. 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 Ncs Healthcare Of Ky, Llc Dba Vangard Labs on January 15, 2024. 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 Ncs Healthcare Of Ky, Llc Dba Vangard Labs product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00615851139. 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)
0615-8511-39
11-Digit CMS (5-4-2)
00615-8511-39

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