1. Home
  2. Labeler Index
  3. Edwards Pharmaceuticals, Inc.
  4. NDC Product Code: 0485-0151 Urogesic Blue

NDC 0485-0151 Urogesic Blue

Methenamine,Sodium Phosphate,Monobasic,Methylene Blue,And Hyoscyamine Sulfate Tablet, - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0485-0151?
  5. Urogesic Blue 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:
0485-0151
Proprietary Name:
Urogesic Blue
Non-Proprietary Name: [1]
Methenamine, Sodium Phosphate, Monobasic, Methylene Blue, And Hyoscyamine Sulfate
Substance Name: [2]
Hyoscyamine Sulfate; Methenamine; Methylene Blue; Sodium Phosphate, Monobasic
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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.
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Edwards Pharmaceuticals, Inc.
    Labeler Code:
    0485
    Product Label ID:
    f650dd78-615c-42d3-9b2d-3a989039d80c
    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]
    11-19-2010
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    BLUE (C48333 - LIGHT BLUE)
    Shape:
    OVAL (C48345)
    Size(s):
    13 MM
    Imprint(s):
    ED;UB
    Score:
    2

    Code Structure Chart

    Product Details

    What is NDC 0485-0151?

    The NDC code 0485-0151 is assigned by the FDA to the product Urogesic Blue which is a human prescription drug product labeled by Edwards Pharmaceuticals, Inc.. The generic name of Urogesic Blue is methenamine, sodium phosphate, monobasic, methylene blue, and hyoscyamine sulfate. The product's dosage form is tablet, coated and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0485-0151-01 100 tablet, coated in 1 bottle, plastic , 0485-0151-30 30 tablet, coated in 1 bottle, plastic . 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 Urogesic Blue?

    UROGESIC-BLUE™ is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as hypermotility which accompany lower urinary tract infections and as antispasmodic. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.

    What are Urogesic Blue 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 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.
    • SODIUM PHOSPHATE, MONOBASIC 40.8 mg/1
    • HYOSCYAMINE SULFATE .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.
    • SODIUM PHOSPHATE, MONOBASIC 40.8 mg/1

    Which are Urogesic Blue UNII Codes?

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

    Which are Urogesic Blue 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 Urogesic Blue?

    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: 1050325 - methenamine 81.6 MG / sodium phosphate, monobasic 40.8 MG / methylene blue 10.8 MG / hyoscyamine sulfate 0.12 MG Oral Tablet
    • RxCUI: 1050325 - hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / sodium phosphate, monobasic 40.8 MG Oral Tablet
    • RxCUI: 1251290 - UROGESIC-BLUE 81.6 MG / 40.8 MG / 10.8 MG / 0.12 MG Oral Tablet, Reformulated Apr 2012
    • RxCUI: 1251290 - hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / sodium phosphate, monobasic 40.8 MG Oral Tablet [Urogesic Blue Reformulated Apr 2012]
    • RxCUI: 1251290 - Urogesic Blue (hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / sodium phosphate, monobasic 40.8 MG) Oral Tablet, Reformulated Apr 2012

    Which are the Pharmacologic Classes for Urogesic Blue?

    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".