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  4. NDC Product Code: 71335-0788 Hyoscyamine SL

NDC 71335-0788 Hyoscyamine SL

Hyoscyamine Sulfate Tablet, Orally Disintegrating Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 71335-0788?
  5. Hyoscyamine SL Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

NDC Product Code:
71335-0788
Proprietary Name:
Hyoscyamine SL
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, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Bryant Ranch Prepack
    Labeler Code:
    71335
    Product Label ID:
    32699ad4-811e-4b6c-a18c-a0bdf9d9161d
    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]
    04-15-2016
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    BLUE (C48333)
    Shape:
    ROUND (C48348)
    Size(s):
    8 MM
    Imprint(s):
    AP;113
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 71335-0788?

    The NDC code 71335-0788 is assigned by the FDA to the product Hyoscyamine SL which is a human prescription drug product labeled by Bryant Ranch Prepack. The generic name of Hyoscyamine SL is hyoscyamine sulfate. The product's dosage form is tablet, orally disintegrating and is administered via oral form. The product is distributed in 9 packages with assigned NDC codes 71335-0788-1 20 tablet, orally disintegrating in 1 bottle , 71335-0788-2 30 tablet, orally disintegrating in 1 bottle , 71335-0788-3 15 tablet, orally disintegrating in 1 bottle , 71335-0788-4 21 tablet, orally disintegrating in 1 bottle , 71335-0788-5 60 tablet, orally disintegrating in 1 bottle , 71335-0788-6 12 tablet, orally disintegrating in 1 bottle , 71335-0788-7 90 tablet, orally disintegrating in 1 bottle , 71335-0788-8 100 tablet, orally disintegrating in 1 bottle , 71335-0788-9 45 tablet, orally disintegrating 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 Hyoscyamine SL?

    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 Hyoscyamine SL 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 Hyoscyamine SL UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Hyoscyamine SL?

    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: 1046982 - hyoscyamine sulfate 0.125 MG Sublingual Tablet
    • RxCUI: 1046982 - hyoscyamine sulfate SL 0.125 Disintegrating Sublingual 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.

    [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".