NDC 71335-1184 Phenazopyridine Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory .
NDC Product Code:
71335-1184
Proprietary Name:
Phenazopyridine Hydrochloride
Product Type: [3]
Labeler Code:
71335
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]
02-01-2011
End Marketing Date: [10]
11-11-2022
Listing Expiration Date: [11]
11-11-2022
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
BROWN (C48332 - MAROON)
Shape:
ROUND (C48348)
Size(s):
10 MM
Imprint(s):
PY;2
Score:
1

Code Structure Chart

Product Details

What is NDC 71335-1184?

The NDC code 71335-1184 is assigned by the FDA to the product Phenazopyridine Hydrochloride which is product labeled by Bryant Ranch Prepack. The product's dosage form is . The product is distributed in 9 packages with assigned NDC codes 71335-1184-1 9 tablet in 1 bottle , 71335-1184-2 20 tablet in 1 bottle , 71335-1184-3 30 tablet in 1 bottle , 71335-1184-4 10 tablet in 1 bottle , 71335-1184-5 15 tablet in 1 bottle , 71335-1184-6 6 tablet in 1 bottle , 71335-1184-7 90 tablet in 1 bottle , 71335-1184-8 12 tablet in 1 bottle , 71335-1184-9 18 tablet 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 Phenazopyridine Hydrochloride?

Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled.The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed two days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after two days. (See DOSAGE AND ADMINISTRATION section.)

Which are Phenazopyridine Hydrochloride UNII Codes?

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

  • PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17)
  • PHENAZOPYRIDINE (UNII: K2J09EMJ52) (Active Moiety)

Which are Phenazopyridine Hydrochloride 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 Phenazopyridine Hydrochloride?

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:

* 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.

[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.

[10] 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.

[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".