Exforge Tablet, Film Coated
NDC Package 0078-0488-15

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

Package Information

Exforge (amlodipine besylate and valsartan) tablets is a medication used to treat high blood pressure. This formulation utilizes a tablet, film coated delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0488 and is authorized under FDA application NDA021990.

Identification & Billing

NDC Package Code
0078-0488-15
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
0078-0488
11-Digit Billing Format
00078048815
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
Non-Proprietary Name
Amlodipine Besylate And Valsartan
Substance Name
Amlodipine Besylate; Valsartan
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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
Novartis Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA021990
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-20-2007
Listing Expiration
12-31-2027
Exclude Flag
N
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 0078-0488-15 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Exforge, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. This tablet, film coated is formulated for oral use and contains amlodipine besylate; valsartan as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Novartis Pharmaceuticals Corporation on June 20, 2007. The current certification is valid through December 31, 2027.

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 Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078048815. 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 (4-4-2)
0078-0488-15
11-Digit CMS (5-4-2)
00078-0488-15

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