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  4. NDC Product Code: 30698-463 Lopressor Hct

NDC 30698-463 Lopressor Hct

Metoprolol Tartrate And Hydrochlorothiazide Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 30698-463?
  4. Lopressor Hct Uses
  5. Active Ingredients
  6. NDC to RxNorm Crosswalk
  7. Pharmacologic Classes

Product Information

NDC Product Code:
30698-463
Proprietary Name:
Lopressor Hct
Non-Proprietary Name: [1]
Metoprolol Tartrate And Hydrochlorothiazide
Substance Name: [2]
Hydrochlorothiazide; Metoprolol Tartrate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Validus Pharmaceuticals Llc
    Labeler Code:
    30698
    Product Label ID:
    d8964894-3cd8-41c1-a844-148d2ef38a88
    FDA Application Number: [6]
    NDA018303
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    06-30-2014
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 30698-463?

    The NDC code 30698-463 is assigned by the FDA to the product Lopressor Hct which is a human prescription drug product labeled by Validus Pharmaceuticals Llc. The generic name of Lopressor Hct is metoprolol tartrate and hydrochlorothiazide. The product's dosage form is tablet and is administered via oral form. The product is distributed in a single package with assigned NDC code 30698-463-01 100 tablet 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 Lopressor Hct?

    Lopressor HCT is indicated for the management of hypertension.This fixed-combination drug is not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patient's needs, therapy with the fixed combination may be more convenient than with the separate components.

    What are Lopressor 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.
    • METOPROLOL TARTRATE 50 mg/1 - A selective adrenergic beta-1 blocking agent that is commonly used to treat ANGINA PECTORIS; HYPERTENSION; and CARDIAC ARRHYTHMIAS.

    What is the NDC to RxNorm Crosswalk for Lopressor 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: 866479 - metoprolol tartrate 100 MG / hydroCHLOROthiazide 25 MG Oral Tablet
    • RxCUI: 866479 - hydrochlorothiazide 25 MG / metoprolol tartrate 100 MG Oral Tablet
    • RxCUI: 866479 - HCTZ 25 MG / metoprolol tartrate 100 MG Oral Tablet
    • RxCUI: 866482 - metoprolol tartrate 50 MG / hydroCHLOROthiazide 25 MG Oral Tablet
    • RxCUI: 866482 - hydrochlorothiazide 25 MG / metoprolol tartrate 50 MG Oral Tablet

    Which are the Pharmacologic Classes for Lopressor 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.

    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".