NDC 61919-678 Phenazopyridine Hydrochloride

Phenazopyridine Hydrochloride

NDC Product Code 61919-678

NDC Code: 61919-678

Proprietary Name: Phenazopyridine Hydrochloride What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Phenazopyridine Hydrochloride 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.

NDC Code Structure

  • 61919 - Direct Rx
    • 61919-678 - Phenazopyridine Hydrochloride

NDC 61919-678-10

Package Description: 10 TABLET, FILM COATED in 1 BOTTLE

NDC Product Information

Phenazopyridine Hydrochloride with NDC 61919-678 is a a human prescription drug product labeled by Direct Rx. The generic name of Phenazopyridine Hydrochloride is phenazopyridine hydrochloride. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Direct Rx

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.

Product Type: Human Prescription Drug 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.

Phenazopyridine Hydrochloride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Direct Rx
Labeler Code: 61919
Marketing Category: UNAPPROVED DRUG OTHER - 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.

Start Marketing Date: 05-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Phenazopyridine Hydrochloride Product Label Images

Phenazopyridine Hydrochloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Phenazopyridine Hydrochloride is light or dark red to dark violet, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. It has the following structural formula.Chemical Structure

Inactive Ingredients: Corn Starch, Croscarmellose Sodium, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Povidone, Pregelatinized Starch, Propylene Glycol and Silicon Dioxide.

Clinical Pharmacology

Phenazopyridine HCl is excreted in the urine where it exerts a topical analgesic effect on the mucosa of the urinary tract. This action helps to relieve pain, burning, urgency and frequency. The precise mechanism of action is not known.The pharmacokinetic properties of Phenazopyridine HCl have not been determined. Phenazopyridine HCl is rapidly excreted by the kidneys, with as much as 66% of an oral dose being excreted unchanged in the urine.

Indications & Usage

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 2 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 2 days. (See DOSAGE AND ADMINISTRATION section).

Contraindications

Phenazopyridine HCl should not be used in patients who have previously exhibited hypersensitivity to It. The use of Phenazopyridine HCl is contraindicated in patients with renal insufficiency.

Adverse Reactions

Headache, rash, pruritus and occasional gastrointestinal disturbance. An anaphylactoid like reaction has been described. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been reported, usually at overdosage levels (see OVERDOSAGE Section).

Precautions

General

A yellowish tinge of the skin or sclera may indicate accumulation due to impaired renal excretion and the need to discontinue therapy. The decline in renal function associated with advanced age should be kept in mind.
NOTE : Patients should be informed that Phenazopyridine HCl produces a reddish-orange discoloration of the urine and may stain fabric. Staining of contact lenses has been reported.Laboratory Test Interaction

Due to its properties as an azo dye, Phenazopyridine HCl may interfere with urinalysis based on spectrometry or color reactions.
Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term administration of Phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.
Pregnancy Category B

Reproduction studies have been performed in rats at doses up to 50 mg/Kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to Phenazopyridine HCl. There are, however, no adequate and well controlled studies pregnant women. Because animal production studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing mothers

No information is available on the appearance of Phenazopyridine HCl, or its metabolites in human milk.

Dosage & Administration

100 mg Tablets: Average adult dosage is two tablets 3 times a day after meals.200 mg Tablets: Average adult dosage is one tablet 3 times a day after meals.When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration of Phenazopyridine HCl should not exceed 2 days.

Overdosage

Exceeding the recommended dose in patients with good renal function or administering the usual dose to patients with impaired renal function (common in elderly patients) may lead to increased serum levels and toxic reactions. Methemoglobinemia generally follows a massive, acute overdose. Methylene blue, 1 to 2 mg/kg/body weight intravenously or ascorbic acid 100 to 200 mg given orally should cause prompt reduction of the methemoglobinemia and disappearance of the cyanosis which is an aid in diagnosis. Oxidative Heinz body hemolytic anemia may also occur, and "bite cells" (degmacytes) may be present in a chronic overdosage situation. Red blood cell G-6-PD deficiency may predispose to hemolysis. Renal and hepatic impairment and occasional failure, usually due to hypersensitivity, may also occur.

How Supplied

100 mg Tablets: Supplied in bottles of
Appearance: Reddish-brown, round, film coated tablets, debossed "701" on one side and plain on other side.200 mg Tablets: Supplied in bottles of
Appearance: Reddish-brown, round, film coated tablets, debossed "702" on one side and plain on other side.DISPENSE contents with a child-resistant closure (as required) and in a tight container as defined in the USP.STORE at 20° -25°C (68°-77°F) with excursions permitted between 15°-30°C (59°-86°F) [see USP controlled Room Temperature].

* Please review the disclaimer below.

Previous Code
61919-677
Next Code
61919-679