Urelle Tablet
NDC Package 0037-6321-90

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Urelle (hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate) tablets is a medication 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. This formulation utilizes a tablet delivery system. Marketed by Viatris Specialty Llc, this product is identified by NDC 0037-6321.

Identification & Billing

NDC Package Code
0037-6321-90
Package Description
90 TABLET in 1 BOTTLE
Product Code
0037-6321
11-Digit Billing Format
00037632190
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Urelle
Non-Proprietary Name
Hyoscyamine Sulfate, Methenamine, Methylene Blue, Phenyl Salicylate, And Sodium Phosphate, Monobasic, Monohydrate
Substance Name
Hyoscyamine Sulfate; Methenamine; Methylene Blue; Phenyl Salicylate; Sodium Phosphate, Monobasic, Monohydrate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Viatris Specialty Llc
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
01-12-2015
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0037-6321-90 identifies a specific commercial package of 90 tablet in 1 bottle of Urelle, a human prescription drug labeled by Viatris Specialty Llc. This tablet is formulated for oral use and contains hyoscyamine sulfate; methenamine; methylene blue; phenyl salicylate; sodium phosphate, monobasic, monohydrate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Viatris Specialty Llc on January 12, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Viatris Specialty Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00037632190. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0037-6321-90
11-Digit CMS (5-4-2)
00037-6321-90

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.