Uribel Tabs Tablet, Coated
NDC 0178-0745

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0178-0745?
  5. Uribel Tabs Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

Uribel Tabs (methenamine, benzoic acid, phenyl salicylate, methylene blue, and hyoscyamine sulfate) is a UNAPPROVED DRUG OTHER-approved product labeled by Mission Pharmacal Company. This medication is typically used as a ammonium ion binding activity [moa]. It is supplied as a blue tablet, coated for oral administration. This product entry covers the primary NDC 0178-0745 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0178-0745
Proprietary Name:
Uribel Tabs
Non-Proprietary Name: [1]
Methenamine, Benzoic Acid, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate
Substance Name: [2]
Hyoscyamine Sulfate; Phenyl Salicylate; Methenamine; Methylene Blue; Benzoic Acid
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Mission Pharmacal Company
Labeler Code:
0178
Product Label ID:
09821e01-1135-e75c-e063-6294a90a3451
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]
11-07-2023
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
BLUE (C48333)
Shape:
ROUND (C48348)
Size(s):
11 MM
Imprint(s):
SAT;901
Score:
1

Code Structure Chart

Product Details

What is NDC 0178-0745?

The NDC code 0178-0745 is assigned by the FDA to the product Uribel Tabs. It is commonly known by its generic name, methenamine, benzoic acid, phenyl salicylate, methylene blue, and hyoscyamine sulfate. This pharmaceutical product is labeled by Mission Pharmacal Company and is currently categorized as listed product. The medication is a tablet, coated administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0178-0745-01. 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?

Uribel Tabs are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.

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 9 mg/1
  • PHENYL SALICYLATE .12 mg/1
  • METHENAMINE 81.6 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 10.8 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.
  • BENZOIC ACID 36.2 mg/1 - A fungistatic compound that is widely used as a food preservative. It is conjugated to GLYCINE in the liver and excreted as hippuric acid.

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: 1037234 - methenamine 81.6 MG / phenyl salicylate 36.2 MG / methylene blue 10.8 MG / benzoic acid 9 MG / hyoscyamine sulfate 0.12 MG Oral Tablet
  • RxCUI: 1037234 - benzoic acid 9 MG / hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / phenyl salicylate 36.2 MG Oral Tablet
  • RxCUI: 2670308 - Uribel Tabs 81.6 MG / 9 MG / 36.2 MG / 10.8 MG / 0.12 MG Oral Tablet
  • RxCUI: 2670308 - benzoic acid 9 MG / hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / phenyl salicylate 36.2 MG Oral Tablet [Uribel Tabs]
  • RxCUI: 2670308 - Uribel Tabs (benzoic acid 9 MG / hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / phenyl salicylate 36.2 MG) Oral Tablet

Which are the Pharmacologic Classes of this product?

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.

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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".