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  4. NDC Product Code: 13913-001 Proquin XR

NDC 13913-001 Proquin XR

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 13913-001?
  5. Proquin XR 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.
NDC Product Code:
13913-001
Proprietary Name:
Proquin XR
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Depomed, Inc.
Labeler Code:
13913
Product Label ID:
ff17b6d9-4a76-4cce-af88-aa8316018be6
Start Marketing Date: [9]
10-01-2005
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333 - BLUE)
Shape:
OVAL (C48345)
Size(s):
18 MM
Imprint(s):
DMI;500
Score:
1

Code Structure Chart

Product Details

What is NDC 13913-001?

The NDC code 13913-001 is assigned by the FDA to the product Proquin XR which is product labeled by Depomed, Inc.. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 13913-001-03 1 blister pack in 1 carton / 3 tablet, film coated, extended release in 1 blister pack, 13913-001-30 30 tablet, film coated, extended release in 1 bottle , 13913-001-91 1 blister pack in 1 carton / 1 tablet, film coated, extended release in 1 blister pack. 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 Proquin XR?

Proquin XR is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of the designated microorganisms listed below. Proquin XR is not interchangeable with other ciprofloxacin extended-release or immediate release oral formulations. See DOSAGE AND ADMINISTRATION for specific recommendations.Uncomplicated urinary tract infections (acute cystitis) caused by Escherichia coli and Klebsiella pneumoniae.THE SAFETY AND EFFICACY OF PROQUIN XR IN TREATING PYELONEPHRITIS, COMPLICATED URINARY TRACT INFECTIONS, AND INFECTIONS OTHER THAN UNCOMPLICATED URINARY TRACT INFECTIONS HAVE NOT BEEN DEMONSTRATED. Alternative therapy should be considered for patients who remain symptomatic or develop fever and back pain while on treatment with Proquin XR.To reduce the development of drug-resistant bacteria and maintain the effectiveness of Proquin XR and other antibacterial drugs, Proquin XR should only be used to treat uncomplicated urinary tract infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and sensitivity information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Which are Proquin XR UNII Codes?

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

Which are Proquin XR 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 Proquin XR?

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: 359383 - ciprofloxacin 500 MG 24HR Extended Release Oral Tablet
  • RxCUI: 359383 - 24 HR ciprofloxacin 500 MG Extended Release Oral Tablet
  • RxCUI: 359383 - ciprofloxacin 500 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 672912 - Proquin XR 500 MG 24HR Extended Release Oral Tablet
  • RxCUI: 672912 - 24 HR ciprofloxacin 500 MG Extended Release Oral Tablet [Proquin]

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[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".