Aggrenox
NDC Package 0597-0001-60
Package Information
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 Boehringer Ingelheim Pharmaceuticals Inc., this product is identified by NDC 0597-0001 and is authorized under FDA application NDA020884.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0597 - Boehringer Ingelheim Pharmaceuticals Inc.
- 0597-0001 - Aggrenox
- 0597-0001-60 - 1 BOTTLE in 1 CARTON / 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
- 0597-0001 - Aggrenox
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.
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Other Available Packages
The following commercial packages are registered under the same Product NDC (0597-0001). Click a package code to view its specific billing and regulatory data.
* 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 0597-0001-60 identifies a specific commercial package of 1 bottle in 1 carton / 60 capsule, extended release in 1 bottle of Aggrenox, labeled by Boehringer Ingelheim Pharmaceuticals Inc.. 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 Boehringer Ingelheim Pharmaceuticals Inc. on December 19, 1999. The current certification is valid through March 31, 2021.
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 Boehringer Ingelheim Pharmaceuticals Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00597000160. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.