NDC 64543-118 Symax Duotab

Hyoscyamine Sulfate Tablet, Multilayer, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
64543-118
Proprietary Name:
Symax Duotab
Non-Proprietary Name: [1]
Hyoscyamine Sulfate
Substance Name: [2]
Hyoscyamine Sulfate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Multilayer, Extended Release - A solid dosage form containing medicinal substances that have been compressed to form a multiple-layered tablet or a tablet-within-a-tablet, the inner tablet being the core and the outer portion being the shell, which, additionally, is covered in a designated coating; the tablet is formulated in such manner as to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Capellon Pharmaceuticals, Llc
    Labeler Code:
    64543
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    11-07-2009
    End Marketing Date: [10]
    12-16-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - LAYER 2)
    PURPLE (C48327 - LAYER 1)
    Shape:
    OVAL (C48345)
    Size(s):
    15 MM
    Imprint(s):
    SYMAX;DUOTAB
    Score:
    1

    Product Packages

    NDC Code 64543-118-02

    Package Description: 12 POUCH in 1 CARTON / 1 TABLET, MULTILAYER, EXTENDED RELEASE in 1 POUCH

    NDC Code 64543-118-90

    Package Description: 90 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE

    Product Details

    What is NDC 64543-118?

    The NDC code 64543-118 is assigned by the FDA to the product Symax Duotab which is a human prescription drug product labeled by Capellon Pharmaceuticals, Llc. The generic name of Symax Duotab is hyoscyamine sulfate. The product's dosage form is tablet, multilayer, extended release and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 64543-118-02 12 pouch in 1 carton / 1 tablet, multilayer, extended release in 1 pouch, 64543-118-90 90 tablet, multilayer, extended release 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 Symax Duotab?

    Hyoscyamine is used to treat a variety of stomach/intestinal problems such as cramps and irritable bowel syndrome. It is also used to treat other conditions such as bladder and bowel control problems, cramping pain caused by kidney stones and gallstones, and Parkinson's disease. In addition, it is used to decrease side effects of certain medications (drugs used to treat myasthenia gravis) and insecticides. This medication works by decreasing acid production in the stomach, slowing down the natural movements of the gut, and relaxing muscles in many organs (such as the stomach, intestines, bladder, kidney, gallbladder). Hyoscyamine also lessens the amount of certain body fluids (e.g., saliva, sweat). This medication belongs to a class of drugs known as anticholinergics/antispasmodics.

    What are Symax Duotab 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 Symax Duotab UNII Codes?

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

    Which are Symax Duotab 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 Symax Duotab?

    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: 1807886 - hyoscyamine sulfate 0.375 MG Biphasic 12HR Extended Release Oral Tablet
    • RxCUI: 1807886 - Biphasic 12 HR hyoscyamine sulfate 0.375 MG Extended Release Oral Tablet
    • RxCUI: 1807886 - hyoscyamine sulfate 0.375 MG Biphasic (0.125 MG / 0.25 MG) 12 HR Extended Release Oral Tablet
    • RxCUI: 1807886 - hyoscyamine sulfate 0.375 MG Biphasic 12 HR Extended Release Oral Tablet
    • RxCUI: 1807887 - Symax Duotab 0.375 MG Biphasic 12HR Extended Release Oral Tablet

    * Please review the disclaimer below.

    Patient Education

    Hyoscyamine


    Hyoscyamine is used to control symptoms associated with disorders of the gastrointestinal (GI) tract. It works by decreasing the motion of the stomach and intestines and the secretion of stomach fluids, including acid. Hyoscyamine is also used in the treatment of bladder spasms, peptic ulcer disease, diverticulitis, colic, irritable bowel syndrome, cystitis, and pancreatitis. Hyoscyamine may also be used to treat certain heart conditions, to control the symptoms of Parkinson's disease and rhinitis (runny nose), and to reduce excess saliva production.
    [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.

    [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.

    [10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

    [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".