NDC 33261-150 Phenazopyridine Hydrochloride

NDC Product Code 33261-150

NDC CODE: 33261-150

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.

Product Characteristics

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

NDC Code Structure

NDC 33261-150-06

Package Description: 6 TABLET in 1 BOTTLE, PLASTIC

NDC 33261-150-09

Package Description: 9 TABLET in 1 BOTTLE, PLASTIC

NDC 33261-150-10

Package Description: 10 TABLET in 1 BOTTLE, PLASTIC

NDC 33261-150-15

Package Description: 15 TABLET in 1 BOTTLE, PLASTIC

NDC 33261-150-20

Package Description: 20 TABLET in 1 BOTTLE, PLASTIC

NDC 33261-150-30

Package Description: 30 TABLET in 1 BOTTLE, PLASTIC

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Phenazopyridine Hydrochloride with NDC 33261-150 is a product labeled by Aidarex Pharmaceuticals Llc. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1094104 and 1094107.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POVIDONES (UNII: FZ989GH94E)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POVIDONES (UNII: FZ989GH94E)
  • STARCH, CORN (UNII: O8232NY3SJ)

Product Labeler Information

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

Labeler Name: Aidarex Pharmaceuticals Llc
Labeler Code: 33261
Start Marketing Date: 02-01-2011 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: 12-31-2019 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

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Information for Patients

Phenazopyridine

Phenazopyridine is pronounced as (fen az oh peer' i deen)

Why is phenazopyridine medication prescribed?
Phenazopyridine relieves urinary tract pain, burning, irritation, and discomfort, as well as urgent and frequent urination caused by urinary tract infections, surgery, in...
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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:Phenazopyridine HCl tablets contain the following inactive ingredients: carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch.

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 And 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 to50 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 in pregnant women. Because animal reproduction 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 And 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 6 (NDC 33261-132-06),  15 (NDC 33261-132-15) and 30 (NDC 33261-132-30) counts.Appearance: Deep brown to maroon colored, round, film coated tablets debossed “AN” above “1” on one side and plain on the other.200 mg Tablets: Supplied in bottles of 6 (NDC 33261-150-06), 9 (NDC 33261-150-09), 10 (NDC 33261-150-10), 15 (NDC 33261-150-15), 20 (NDC 33261-150-20) and 30 (NDC 33261-150-30) counts.Appearance: Deep brown to maroon colored, round, film coated tablets debossed “AN” above “2” on one side and plain on the other.DISPENSE contents with a child-resistant closure (as required) and in a tight container as defined in the USP.STORE at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

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