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  3. NDC Product Code: 0037-6321 Urelle

NDC 0037-6321 Urelle

Hyoscyamine Sulfate,Methenamine,Methylene Blue,Phenyl Salicylate,And Sodium - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

    1. Product Information
    2. Product Packages
    3. Product Characteristics
    4. What is NDC 0037-6321?
    5. Urelle Uses
    6. Active Ingredients
    7. Active Ingredients UNII Codes
    8. Inactive Ingredients UNII Codes
    9. NDC to RxNorm Crosswalk
    10. Pharmacologic Classes

Product Information

NDC Product Code:
0037-6321
Proprietary Name:
Urelle
Non-Proprietary Name: [1]
Hyoscyamine Sulfate, Methenamine, Methylene Blue, Phenyl Salicylate, And Sodium Phosphate, Monobasic, Monohydrate
Substance Name: [2]
Hyoscyamine Sulfate; Methenamine; Methylene Blue; Phenyl Salicylate; Sodium Phosphate, Monobasic, Monohydrate
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]
    Meda Pharmaceuticals
    Labeler Code:
    0037
    Product Label ID:
    1d80a11c-6f86-403b-85d4-32ec1924dbe9
    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]
    01-12-2015
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    BLUE (C48333)
    Shape:
    ROUND (C48348)
    Size(s):
    11 MM
    Imprint(s):
    A002
    Score:
    1

    Product Packages

    NDC Code 0037-6321-90

    Package Description: 90 TABLET in 1 BOTTLE

    Product Details

    What is NDC 0037-6321?

    The NDC code 0037-6321 is assigned by the FDA to the product Urelle which is a human prescription drug product labeled by Meda Pharmaceuticals. The generic name of Urelle is hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate. 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 0037-6321-90 90 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 Urelle?

    This medication is used to relieve the discomfort, pain, frequent urge to urinate, and cramps/spasms of the urinary tract caused by an infection or a medical procedure. Methenamine is an antibiotic. Methylene blue is an antiseptic and is related to a group of drugs called monoamine oxidase inhibitors (MAO inhibitors). Both methenamine and methylene blue help to prevent the growth of bacteria in the urine. Salicylate, which is related to aspirin, is a pain reliever. This product also contains an ingredient (such as sodium phosphate, benzoic acid) to make the urine more acidic, which helps methenamine work better. Hyoscyamine is an antispasmodic drug that relaxes the muscles of the urinary tract to relieve cramps/spasms. This product should not be used to treat a urinary tract infection. If you have a bacterial infection, another antibiotic is usually prescribed to treat it. Consult your doctor for more details. This medication is not recommended for children younger than 6 years because they are more sensitive to the side effects.

    What are Urelle 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 Urelle UNII Codes?

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

    Which are Urelle 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 Urelle?

    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: 1048336 - methenamine 81 MG / sodium phosphate, monobasic 40.8 MG / phenyl salicylate 32.4 MG / methylene blue 10.8 MG / hyoscyamine sulfate 0.12 MG Oral Tablet
    • RxCUI: 1048336 - hyoscyamine sulfate 0.12 MG / methenamine 81 MG / methylene blue 10.8 MG / phenyl salicylate 32.4 MG / sodium phosphate, monobasic 40.8 MG Oral Tablet
    • RxCUI: 1048340 - urelle Urinary Antiseptic 0.12 MG / 81 MG / 10.8 MG / 32.4 MG / 40.8 MG Oral Tablet
    • RxCUI: 1048340 - hyoscyamine sulfate 0.12 MG / methenamine 81 MG / methylene blue 10.8 MG / phenyl salicylate 32.4 MG / sodium phosphate, monobasic 40.8 MG Oral Tablet [Urelle]
    • RxCUI: 1048340 - Urelle (hyoscyamine sulfate 0.12 MG / methenamine 81 MG / methylene blue 10.8 MG / phenyl salicylate 32.4 MG / sodium phosphate, monobasic 40.8 MG) Oral Tablet

    Which are the Pharmacologic Classes for Urelle?

    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.

    [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".