Ustell
NDC 0076-0903

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0076-0903?
  5. Ustell Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Ustell is a UNAPPROVED DRUG OTHER-approved product labeled by Star 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 product. This product entry covers the primary NDC 0076-0903 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0076-0903
Proprietary Name:
Ustell
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Star Pharmaceuticals Llc
Labeler Code:
0076
Product Label ID:
dc773b57-378b-4650-9bb0-34e6f8c067ab
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]
09-27-2010
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I

Product Characteristics

Color(s):
BLUE (C48333)
Shape:
CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
S903
Score:
1

Code Structure Chart

Product Details

What is NDC 0076-0903?

The NDC code 0076-0903 is assigned by the FDA to the product Ustell. This pharmaceutical product is labeled by Star Pharmaceuticals Llc and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0076-0903-01. 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.

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: 1048307 - hyoscyamine sulfate 0.12 MG / methenamine 120 MG / methylene blue 10 MG / phenyl salicylate 36 MG / sodium phosphate, monobasic 40.8 MG Oral Capsule
  • RxCUI: 1101637 - Ustell 120 MG / 40.8 MG / 36 MG / 10 MG / 0.12 MG Oral Capsule
  • RxCUI: 1101637 - hyoscyamine sulfate 0.12 MG / methenamine 120 MG / methylene blue 10 MG / phenyl salicylate 36 MG / sodium phosphate, monobasic 40.8 MG Oral Capsule [Ustell]
  • RxCUI: 1101637 - Ustell (hyoscyamine sulfate 0.12 MG / methenamine 120 MG / methylene blue 10 MG / phenyl salicylate 36 MG / sodium phosphate, monobasic 40.8 MG) Oral Capsule

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Product & Regulatory Definitions
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".