NDC 0078-0383 Diovan Hct

Valsartan And Hydrochlorothiazide Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0078-0383
Proprietary Name:
Diovan Hct
Non-Proprietary Name: [1]
Valsartan And Hydrochlorothiazide
Substance Name: [2]
Hydrochlorothiazide; Valsartan
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Code:
    0078
    FDA Application Number: [6]
    NDA020818
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    03-06-1998
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    ORANGE (C48331 - LIGHT ORANGE)
    RED (C48326 - DARK RED)
    BROWN (C48332 - BROWN ORANGE)
    Shape:
    OVAL (C48345)
    Size(s):
    10 MM
    15 MM
    14 MM
    Imprint(s):
    CG;HGH
    CG;HHH
    NVR;HXH
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 0078-0383?

    The NDC code 0078-0383 is assigned by the FDA to the product Diovan Hct which is a human prescription drug product labeled by Novartis Pharmaceuticals Corporation. The generic name of Diovan Hct is valsartan and hydrochlorothiazide. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in a single package with assigned NDC code 0078-0383-34 90 tablet, film coated in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Diovan Hct?

    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.

    What are Diovan Hct Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • HYDROCHLOROTHIAZIDE 25 mg/1 - A thiazide diuretic often considered the prototypical member of this class. It reduces the reabsorption of electrolytes from the renal tubules. This results in increased excretion of water and electrolytes, including sodium, potassium, chloride, and magnesium. It is used in the treatment of several disorders including edema, hypertension, diabetes insipidus, and hypoparathyroidism.
    • VALSARTAN 160 mg/1 - A tetrazole derivative and ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to treat HYPERTENSION.

    Which are Diovan Hct UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Diovan Hct Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Diovan Hct?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • 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

    Which are the Pharmacologic Classes for Diovan Hct?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Hydrochlorothiazide


    Hydrochlorothiazide is used alone or in combination with other medications to treat high blood pressure. Hydrochlorothiazide is used to treat edema (fluid retention; excess fluid held in body tissues) caused by various medical problems, including heart, kidney, and liver disease and to treat edema caused by using certain medications including estrogen and corticosteroids. Hydrochlorothiazide is in a class of medications called diuretics ('water pills'). It works by causing the kidneys to get rid of unneeded water and salt from the body into the urine. High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.
    [Learn More]


    Valsartan and Hydrochlorothiazide


    Combination product This product contains two medications, valsartan and hydrochlorothiazide. Please see the individual monographs for information about each of the medications contained in this product.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".