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  4. NDC Product Code: 52389-241 Uricalm Maximum Strength

NDC 52389-241 Uricalm Maximum Strength

Phenazopyridine Hydochloride 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 52389-241?
  5. Uricalm Maximum Strength 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:
52389-241
Proprietary Name:
Uricalm Maximum Strength
Non-Proprietary Name: [1]
Phenazopyridine Hydochloride
Substance Name: [2]
Phenazopyridine Hydrochloride
NDC Directory Status:
Human Otc 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]
    Alva-amco Pharmacal Companies, Inc.
    Labeler Code:
    52389
    Product Label ID:
    1d94b45c-ee0b-499d-aca2-e8cd8dd490d2
    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]
    04-29-2008
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    RED (C48326)
    Shape:
    ROUND (C48348)
    Size(s):
    7 MM
    Imprint(s):
    ALVA;1
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 52389-241?

    The NDC code 52389-241 is assigned by the FDA to the product Uricalm Maximum Strength which is a human over the counter drug product labeled by Alva-amco Pharmacal Companies, Inc.. The generic name of Uricalm Maximum Strength is phenazopyridine hydochloride. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 52389-241-24 1 blister pack in 1 carton / 24 tablet, film coated in 1 blister pack (52389-241-01), 52389-241-28 1 blister pack in 1 carton / 28 tablet, film coated in 1 blister pack (52389-241-04), 52389-241-48 2 blister pack in 1 carton / 24 tablet, film coated 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 Uricalm Maximum Strength?

    Read all package directions and warnings before use.Use only as directed.Do not exceed recommended dosage.Adults:  Swallow two (2) tablets with water after meals as needed up to 3 times daily for 2 days maximum.Swallow whole. Do not crush or chew.Do not use more than 12 tablets in 2 days.Drink 6 to 8 eight glasses of water daily.For use by normally healthy adults only.  Persons under 18 years of age should use only as directed by a doctor.

    What are Uricalm Maximum Strength 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 99.5 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 Uricalm Maximum Strength UNII Codes?

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

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

    Which are Uricalm Maximum Strength 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 Uricalm Maximum Strength?

    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.

    [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".