Aggrenox
NDC Package 21695-656-60

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Aggrenox is a medication used to reduce the risk of stroke in patients who have had "mini-strokes" (transient ischemic attacks) or a previous stroke due to a blood clot and are at high risk for another stroke. Marketed by Rebel Distributors Corp., this product is identified by NDC 21695-656 and is authorized under FDA application NDA020884.

Identification & Billing

NDC Package Code
21695-656-60
Package Description
60 CAPSULE in 1 BOTTLE
Product Code
21695-656
11-Digit Billing Format
21695065660
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk
  • RxCUI: 1362082 - Aggrenox 25 MG / 200 MG 12HR Extended Release Oral Capsule
  • RxCUI: 1362082 - 12 HR aspirin 25 MG / dipyridamole 200 MG Extended Release Oral Capsule [Aggrenox]
  • RxCUI: 1362082 - 12 HR ASA 25 MG / Dipyridamole 200 MG Extended Release Oral Capsule [Aggrenox]
  • RxCUI: 1362082 - Aggrenox 25/200 (aspirin 25 MG / dipyridamole 200 MG) 12HR Extended Release Oral Capsule
  • RxCUI: 1362082 - Aggrenox 25/200 12HR Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Aggrenox
Dosage Form
-
Usage Information
This medication is used to reduce the risk of stroke in patients who have had "mini-strokes" (transient ischemic attacks) or a previous stroke due to a blood clot and are at high risk for another stroke. It contains two medications: a very low dose of aspirin (25 milligrams per tablet) and dipyridamole in a slow-release form. Low-dose aspirin and dipyridamole are antiplatelet drugs that work to keep blood flowing to the brain by stopping platelets from clumping together. This helps prevent the platelets from forming blood clots, which can lodge in the brain and cause a certain type of stroke (ischemic stroke).

Regulatory & Marketing

Labeler Name
Rebel Distributors Corp.
FDA Application #
NDA020884
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-19-1999
Listing Expiration
12-31-2017
Exclude Flag
I
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 21695-656-60 identifies a specific commercial package of 60 capsule in 1 bottle of Aggrenox, labeled by Rebel Distributors Corp.. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Rebel Distributors Corp. on December 19, 1999. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This medication is used to reduce the risk of stroke in patients who have had "mini-strokes" (transient ischemic attacks) or a previous stroke due to a blood clot and are at high risk for another stroke. It contains two medications: a very low dose of aspirin (25 milligrams per tablet) and dipyridamole in a slow-release form. Low-dose aspirin and dipyridamole are antiplatelet drugs that work to keep blood flowing to the brain by stopping platelets from clumping together. This helps prevent the platelets from forming blood clots, which can lodge in the brain and cause a certain type of stroke (ischemic stroke).

How is this Rebel Distributors Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21695065660. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 total billable units per package. 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 (5-3-2)
21695-656-60
11-Digit CMS (5-4-2)
21695-0656-60

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