NDC 0093-1062 Sotalol Hydrochloride

Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0093-1062
Proprietary Name:
Sotalol Hydrochloride
Non-Proprietary Name: [1]
Sotalol Hydrochloride
Substance Name: [2]
Sotalol Hydrochloride
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]
    Teva Pharmaceuticals Usa, Inc.
    Labeler Code:
    0093
    FDA Application Number: [6]
    ANDA075429
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    05-05-2000
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    BLUE (C48333 - LIGHT BLUE)
    Shape:
    OVAL (C48345)
    Size(s):
    12 MM
    14 MM
    15 MM
    Imprint(s):
    93;61
    93;1060
    93;62
    Score:
    2

    Product Packages

    NDC Code 0093-1062-01

    Package Description: 100 TABLET in 1 BOTTLE

    Price per Unit: $0.17443 per EA

    Product Details

    What is NDC 0093-1062?

    The NDC code 0093-1062 is assigned by the FDA to the product Sotalol Hydrochloride which is a human prescription drug product labeled by Teva Pharmaceuticals Usa, Inc.. 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 0093-1062-01 100 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 Sotalol Hydrochloride?

    Sotalol hydrochloride tablets are contraindicated in patients with:•Sinus bradycardia, sick sinus syndrome, second and third degree AV block, unless a functioning pacemaker is present•Congenital or acquired long QT syndromes•Cardiogenic shock or decompensated heart failure•Serum potassium <4 mEq/L•Bronchial asthma or related bronchospastic conditions•Hypersensitivity to sotalolFor the treatment of AFIB/AFL, sotalol hydrochloride tablets are also contraindicated in patients with:•Baseline QT interval >450 ms•Creatinine clearance <40 mL/min

    What are Sotalol Hydrochloride 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.

    Which are Sotalol Hydrochloride UNII Codes?

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

    Which are Sotalol Hydrochloride 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 Sotalol Hydrochloride?

    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:

    Which are the Pharmacologic Classes for Sotalol Hydrochloride?

    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

    Sotalol


    Sotalol is used to treat irregular heartbeats. Sotalol is in a class of medications called antiarrhythmics. It works by acting on the heart muscle to improve the heart's rhythm.
    [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".