Uro-mp Capsule
NDC 58657-456

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 58657-456?
  5. Uro-mp Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

Uro-mp (methenamine, sodium phosphate, monobasic, anhydrous, phenyl salicylate, methylene blue and hyoscyamine sulfate) is a UNAPPROVED DRUG OTHER-approved product labeled by Method Pharmaceuticals, Llc. 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. It is supplied as a blue capsule for oral administration. This product entry covers the primary NDC 58657-456 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
58657-456
Proprietary Name:
Uro-mp
Non-Proprietary Name: [1]
Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue And Hyoscyamine Sulfate
Substance Name: [2]
Hyoscyamine Sulfate; Methenamine; Methylene Blue; Phenyl Salicylate; Sodium Phosphate, Monobasic, Anhydrous
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

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 & Regulatory Data

Labeler Name: [5]
Method Pharmaceuticals, Llc
Labeler Code:
58657
Product Label ID:
1e1b0dee-1a3b-4846-a212-c9febb3fc17d
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
12-01-2014
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
BLUE (C48333)
Shape:
CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
200
Score:
1

Code Structure Chart

Product Details

What is NDC 58657-456?

The NDC code 58657-456 is assigned by the FDA to the product Uro-mp. It is commonly known by its generic name, methenamine, sodium phosphate, monobasic, anhydrous, phenyl salicylate, methylene blue and hyoscyamine sulfate. This pharmaceutical product is labeled by Method Pharmaceuticals, Llc and is currently categorized as listed product. The medication is a capsule administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 58657-456-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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 Active Ingredients of this product?

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, ANHYDROUS 40.8 mg/1

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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

Which are the Pharmacologic Classes of this product?

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Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".