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  5. NDC Package Code: 0078-0561-30 Exforge Hct

NDC Package 0078-0561-30 Exforge Hct

Amlodipine Valsartan And Hydrochlorothiazide Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0078-0561-30
Package Description:
30 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
0078-0561
Proprietary Name:
Exforge Hct
Non-Proprietary Name:
Amlodipine Valsartan And Hydrochlorothiazide
Substance Name:
Amlodipine Besylate; Hydrochlorothiazide; Valsartan
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 3 medications: amlodipine, valsartan, and hydrochlorothiazide. Amlodipine is a calcium channel blocker, and valsartan is an angiotensin receptor blocker (ARB). They both work by relaxing blood vessels so blood can flow more easily. Hydrochlorothiazide is called a "water pill" (diuretic) and causes your body to get rid of extra salt and water by making more urine.
11-Digit NDC Billing Format:
00078056130
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 848131 - amLODIPine 10 MG / valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
  • RxCUI: 848131 - amlodipine 10 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet
  • RxCUI: 848131 - amlodipine (as amlodipine besylate) 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet
  • RxCUI: 848131 - amlodipine 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet
  • RxCUI: 848134 - EXFORGE HCT 10 MG / 160 MG / 12.5 MG Oral Tablet
Product Type:
Human Prescription Drug
Labeler Name:
Novartis Pharmaceuticals Corporation
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
NDA022314
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
04-04-2009
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
0078-0561-1530 TABLET, FILM COATED in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0078-0561-30?

The NDC Packaged Code 0078-0561-30 is assigned to a package of 30 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack of Exforge Hct, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 0078-0561 included in the NDC Directory?

Yes, Exforge Hct with product code 0078-0561 is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on April 04, 2009 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0078-0561-30?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

What is the 11-digit format for NDC 0078-0561-30?

The 11-digit format is 00078056130. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20078-0561-305-4-200078-0561-30