Felodipine
NDC Package 55648-412-01

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

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.Felodipine extended-release tablets may be used alone or concomitantly with other antihypertensive agents. Marketed by Wockhardt Limited, this product is identified by NDC 55648-412 and is authorized under FDA application ANDA091484.

Identification & Billing

NDC Package Code
55648-412-01
Package Description
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
55648-412
11-Digit Billing Format
55648041201
RxNorm Crosswalk
  • RxCUI: 402695 - felodipine 10 MG 24HR Extended Release Oral Tablet
  • RxCUI: 402695 - 24 HR felodipine 10 MG Extended Release Oral Tablet
  • RxCUI: 402695 - felodipine 10 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 402696 - felodipine 5 MG 24HR Extended Release Oral Tablet
  • RxCUI: 402696 - 24 HR felodipine 5 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Felodipine
Dosage Form
-
Usage Information
Felodipine extended-release tablets are indicated for the treatment of hypertension.Felodipine extended-release tablets may be used alone or concomitantly with other antihypertensive agents.

Regulatory & Marketing

Labeler Name
Wockhardt Limited
FDA Application #
ANDA091484
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-05-2010
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (55648-412). Click a package code to view its specific billing and regulatory data.

55648-412-02
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
55648-412-03
10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
55648-412-04
500 TABLET, FILM COATED, 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 55648-412-01 identifies a specific commercial package of 30 tablet, film coated, extended release in 1 bottle of Felodipine, labeled by Wockhardt Limited. 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 Wockhardt Limited on December 05, 2010. The current certification is valid through December 31, 2018.

How is this Wockhardt Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55648041201. 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)
55648-412-01
11-Digit CMS (5-4-2)
55648-0412-01

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