Uroav-81
NDC 15338-502

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 15338-502?
  5. Uroav-81 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 discontinued by the firm.

Uroav-81 is a UNAPPROVED DRUG OTHER-approved product labeled by Apace Packaging, Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a blue product. This product entry covers the primary NDC 15338-502 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
15338-502
Proprietary Name:
Uroav-81
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Apace Packaging, Llc
Labeler Code:
15338
Product Label ID:
6cbeb7be-397b-819f-e053-2a91aa0a208e
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]
02-02-2016
End Marketing Date: [10]
11-16-2023
Listing Expiration Date: [11]
11-16-2023
Exclude Flag: [12]
D

Product Characteristics

Color(s):
BLUE (C48333 - BLUE, SPECKLED)
Shape:
CAPSULE (C48336)
Size(s):
15 MM
Imprint(s):
210
Score:
1

Code Structure Chart

Product Details

What is NDC 15338-502?

The NDC code 15338-502 is assigned by the FDA to the product Uroav-81. This pharmaceutical product is labeled by Apace Packaging, 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: 15338-502-09. 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?

 UroAv-81 Tablets is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections.Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.

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: 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

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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 End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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".