Exforge
NDC Package 54868-5804-0

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.

Exforge is a medication used to treat high blood pressure. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5804 and is authorized under FDA application NDA021990.

Identification & Billing

NDC Package Code
54868-5804-0
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
54868-5804
11-Digit Billing Format
54868580400
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 722126 - amLODIPine 10 MG / valsartan 160 MG Oral Tablet
  • RxCUI: 722126 - amlodipine 10 MG / valsartan 160 MG Oral Tablet
  • RxCUI: 722126 - amlodipine (as amlodipine besylate) 10 MG / valsartan 160 MG Oral Tablet
  • RxCUI: 722131 - amLODIPine 10 MG / valsartan 320 MG Oral Tablet
  • RxCUI: 722131 - amlodipine 10 MG / valsartan 320 MG Oral Tablet

Clinical Specifications

Proprietary Name
Exforge
Dosage Form
-
Usage Information
This product is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This product contains 2 medications: amlodipine and valsartan. They both work by relaxing blood vessels so blood can flow more easily. Amlodipine is a calcium channel blocker and valsartan is an angiotensin receptor blocker (ARB).

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA021990
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-15-2007
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 54868-5804-0 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Exforge, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 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 Physicians Total Care, Inc. on August 15, 2007. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This product is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This product contains 2 medications: amlodipine and valsartan. They both work by relaxing blood vessels so blood can flow more easily. Amlodipine is a calcium channel blocker and valsartan is an angiotensin receptor blocker (ARB).

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868580400. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 (5-4-1)
54868-5804-0
11-Digit CMS (5-4-2)
54868-5804-00

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