NDC 0076-0111 Uribel

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
0076-0111
Proprietary Name:
Uribel
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
0076
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]
08-01-2010
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
PURPLE (C48327)
Shape:
CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
S;111
Score:
1

Code Structure Chart

Product Details

What is NDC 0076-0111?

The NDC code 0076-0111 is assigned by the FDA to the product Uribel which is product labeled by Star Pharmaceuticals, Llc. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 0076-0111-01 100 capsule in 1 bottle , 0076-0111-02 20 pouch in 1 box / 1 capsule in 1 pouch. 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 Uribel?

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 Uribel UNII Codes?

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

Which are Uribel 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:

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Product Footnotes

[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".