Felodipine
NDC Package 68151-3083-0

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.

Felodipine is extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Marketed by Carilion Materials Management, this product is identified by NDC 68151-3083 and is authorized under FDA application ANDA075896.

Identification & Billing

NDC Package Code
68151-3083-0
Package Description
1 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE
Product Code
68151-3083
11-Digit Billing Format
68151308300
RxNorm Crosswalk
  • RxCUI: 402698 - felodipine 2.5 MG 24HR Extended Release Oral Tablet
  • RxCUI: 402698 - 24 HR felodipine 2.5 MG Extended Release Oral Tablet
  • RxCUI: 402698 - felodipine 2.5 MG 24 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Felodipine
Dosage Form
-
Usage Information
Felodipine extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including felodipine.Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.Felodipine extended-release tablets may be administered with other antihypertensive agents.

Regulatory & Marketing

Labeler Name
Carilion Materials Management
FDA Application #
ANDA075896
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-02-2004
Listing Expiration
12-31-2018
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 68151-3083-0 identifies a specific commercial package of 1 tablet, film coated, extended release in 1 package of Felodipine, labeled by Carilion Materials Management. 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 Carilion Materials Management on November 02, 2004. The current certification is valid through December 31, 2018.

How is this Carilion Materials Management product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68151308300. 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)
68151-3083-0
11-Digit CMS (5-4-2)
68151-3083-00

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