NDC Package 0078-0383-15 Diovan Hct

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

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:
0078-0383-15
Package Description:
30 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0383-61)
Product Code:
Proprietary Name:
Diovan Hct
Non-Proprietary Name:
Valsartan And Hydrochlorothiazide
Substance Name:
Hydrochlorothiazide; Valsartan
Usage Information:
This drug is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This product contains two medications: valsartan and hydrochlorothiazide. Valsartan is an angiotensin receptor blocker (ARB) and works by relaxing blood vessels so that blood can flow more easily. Hydrochlorothiazide is a "water pill" (diuretic) that causes you to make more urine, which helps your body get rid of extra salt and water.
11-Digit NDC Billing Format:
00078038315
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: 200284 - HCTZ 12.5 MG / valsartan 80 MG Oral Tablet
  • RxCUI: 200284 - hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet
  • RxCUI: 200285 - valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
  • RxCUI: 200285 - hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet
  • RxCUI: 200285 - HCTZ 12.5 MG / valsartan 160 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.
Sample Package:
No
FDA Application Number:
NDA020818
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
03-06-1998
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.

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Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
0078-0383-3490 TABLET, FILM COATED in 1 BOTTLE

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Frequently Asked Questions

What is NDC 0078-0383-15?

The NDC Packaged Code 0078-0383-15 is assigned to a package of 30 blister pack in 1 box, unit-dose / 1 tablet, film coated in 1 blister pack (0078-0383-61) of Diovan 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 0078-0383 included in the NDC Directory?

Yes, Diovan Hct with product code 0078-0383 is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on March 06, 1998 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 0078-0383-15?

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 0078-0383-15?

The 11-digit format is 00078038315. 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
4-4-20078-0383-155-4-200078-0383-15