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  4. NDC Product Code: 0178-0740 Uribel

NDC 0178-0740 Uribel

Methenamine,Sodium Phosphate,Monobasic,Monohydrate,Phenyl Salicylate,Methylene Blue,And - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0178-0740?
  5. Uribel 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:
0178-0740
Proprietary Name:
Uribel
Non-Proprietary Name: [1]
Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate
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:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Mission Pharmacal Company
    Labeler Code:
    0178
    Product Label ID:
    812cd318-cf6d-416f-e053-2a91aa0a1716
    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]
    04-15-2019
    End Marketing Date: [10]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    PURPLE (C48327)
    Shape:
    CAPSULE (C48336)
    Size(s):
    19 MM
    Imprint(s):
    S;111
    Score:
    1

    Product Packages

    NDC Code 0178-0740-01

    Package Description: 100 CAPSULE in 1 BOTTLE

    Product Details

    What is NDC 0178-0740?

    The NDC code 0178-0740 is assigned by the FDA to the product Uribel which is a human prescription drug product labeled by Mission Pharmacal Company. The generic name of Uribel is methenamine, sodium phosphate, monobasic, monohydrate, phenyl salicylate, methylene blue, and hyoscyamine sulfate. The product's dosage form is capsule and is administered via oral form. The product is distributed in a single package with assigned NDC code 0178-0740-01 100 capsule 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 Uribel?

    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 Uribel 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.
    • HYOSCYAMINE SULFATE .12 mg/1
    • METHENAMINE 118 mg/1 - An anti-infective agent most commonly used in the treatment of urinary tract infections. Its anti-infective action derives from the slow release of formaldehyde by hydrolysis at acidic pH. (From Martindale, The Extra Pharmacopoeia, 30th ed, p173)
    • METHYLENE BLUE 10 mg/1 - A compound consisting of dark green crystals or crystalline powder, having a bronze-like luster. Solutions in water or alcohol have a deep blue color. Methylene blue is used as a bacteriologic stain and as an indicator. It inhibits GUANYLATE CYCLASE, and has been used to treat cyanide poisoning and to lower levels of METHEMOGLOBIN.
    • PHENYL SALICYLATE 36 mg/1
    • SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 40.8 mg/1

    Which are Uribel UNII Codes?

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

    Which are Uribel 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 Uribel?

    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: 1087365 - methenamine 118 MG / sodium phosphate, monobasic 40.8 MG / phenyl salicylate 36 MG / methylene blue 10 MG / hyoscyamine sulfate 0.12 MG Oral Capsule
    • RxCUI: 1087365 - hyoscyamine sulfate 0.12 MG / methenamine 118 MG / methylene blue 10 MG / phenyl salicylate 36 MG / sodium phosphate, monobasic 40.8 MG Oral Capsule
    • RxCUI: 1087367 - Uribel 118 MG / 40.8 MG / 36 MG / 10 MG / 0.12 MG Oral Capsule
    • RxCUI: 1087367 - hyoscyamine sulfate 0.12 MG / methenamine 118 MG / methylene blue 10 MG / phenyl salicylate 36 MG / sodium phosphate, monobasic 40.8 MG Oral Capsule [Uribel]
    • RxCUI: 1087367 - Uribel (hyoscyamine sulfate 0.12 MG / methenamine 118 MG / methylene blue 10 MG / phenyl salicylate 36 MG / sodium phosphate, monobasic 40.8 MG) Oral Capsule

    Which are the Pharmacologic Classes for Uribel?

    * 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".