NDC 0076-0903 Ustell

Table of Contents

    1. Product Information
    2. Product Packages
    3. Product Characteristics
    4. What is NDC 0076-0903?
    5. Ustell Uses
    6. Inactive Ingredients UNII Codes
    7. NDC to RxNorm Crosswalk

Product Information

NDC Product Code0076-0903
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Ustell
NDC Directory StatusINACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Star Pharmaceuticals Llc
Labeler Code0076
SPL SET ID:dc773b57-378b-4650-9bb0-34e6f8c067ab
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		09-27-2010
Listing Expiration Date 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.		12-31-2018
Exclude Flag 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". 		I
NDC Code Structure

Product Characteristics

Color(s)BLUE (C48333)
ShapeCAPSULE (C48336)
Size(s)19 MM
Imprint(s)S903
Score1

Product Packages

NDC Code 0076-0903-01

Package Description: 100 CAPSULE in 1 BOTTLE

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

Product Details

What is NDC 0076-0903?

The NDC code 0076-0903 is assigned by the FDA to the product Ustell which is product labeled by Star Pharmaceuticals Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 0076-0903-01 100 capsule in 1 bottle . 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 Ustell?

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 Ustell 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 Ustell?

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 Label

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