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  4. NDC Product Code: 70518-2169 Phenazopyridine Hydrochloride

NDC 70518-2169 Phenazopyridine Hydrochloride

Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 70518-2169?
  5. Phenazopyridine Hydrochloride Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Patient Education

Product Information

NDC Product Code:
70518-2169
Proprietary Name:
Phenazopyridine Hydrochloride
Non-Proprietary Name: [1]
Phenazopyridine Hydrochloride
Substance Name: [2]
Phenazopyridine Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Remedyrepack Inc.
    Labeler Code:
    70518
    Product Label ID:
    2a62aa60-02fa-47a2-ab27-f3e66e67b9a5
    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]
    06-28-2019
    End Marketing Date: [10]
    06-30-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    BROWN (C48332 - REDDISH-BROWN)
    Shape:
    ROUND (C48348)
    Size(s):
    10 MM
    Imprint(s):
    813

    Product Packages

    NDC Code 70518-2169-0

    Package Description: 30 TABLET, FILM COATED in 1 BLISTER PACK

    NDC Code 70518-2169-1

    Package Description: 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

    NDC Code 70518-2169-2

    Package Description: 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

    NDC Code 70518-2169-3

    Package Description: 9 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

    Product Details

    What is NDC 70518-2169?

    The NDC code 70518-2169 is assigned by the FDA to the product Phenazopyridine Hydrochloride which is a human prescription drug product labeled by Remedyrepack Inc.. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 4 packages with assigned NDC codes 70518-2169-0 30 tablet, film coated in 1 blister pack , 70518-2169-1 6 tablet, film coated in 1 bottle, plastic , 70518-2169-2 21 tablet, film coated in 1 bottle, plastic , 70518-2169-3 9 tablet, film coated in 1 bottle, plastic . 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 mucosa of the lower urinary tract caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters.The use of Phenazopyridine for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. The drug should be used for symptomatic relief of pain and not as a substitute for specific surgery or antimicrobial therapy.Phenazopyridine is compatible with antimicrobial therapy and can help relieve pain and discomfort during the interval before antimicrobial therapy controls the infection.Treatment of a urinary tract infection with Phenazopyridine should not exceed 2 days. There is no evidence that the combined administration of Phenazopyridine and an antimicrobial provides greater benefit than administration of the antimicrobial alone after 2 days. (See Dosage and Administration.)

    What are Phenazopyridine Hydrochloride Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 - A local anesthetic that has been used in urinary tract disorders. Its use is limited by problems with toxicity (primarily blood disorders) and potential carcinogenicity.

    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.

    Patient Education

    Phenazopyridine


    Phenazopyridine relieves urinary tract pain, burning, irritation, and discomfort, as well as urgent and frequent urination caused by urinary tract infections, surgery, injury, or examination procedures. However, phenazopyridine is not an antibiotic; it does not cure infections.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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.

    [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".