NDC 63629-2029 Phenazopyridine Hydrochloride
Phenazopyridine Tablet Oral
What is NDC 63629-2029?
The NDC code 63629-2029 is assigned by the FDA to the product Phenazopyridine Hydrochloride which is a human prescription drug product labeled by Bryant Ranch Prepack. The generic name of Phenazopyridine Hydrochloride is phenazopyridine. The product's dosage form is tablet and is administered via oral form. The product is distributed in a single package with assigned NDC code 63629-2029-1 100 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, RxNorm crosswalk and the complete product label.
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 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.)
|Color(s)||BROWN (C48332) |
|Shape||ROUND (C48348) |
|Size(s)||10 MM |
NDC Code 63629-2029-1
Package Description: 100 TABLET in 1 BOTTLE
What are Phenazopyridine Hydrochloride Active Ingredients?
- 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.
Phenazopyridine Hydrochloride Active Ingredients UNII Codes
- PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17)
- PHENAZOPYRIDINE (UNII: K2J09EMJ52) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 1094104 - phenazopyridine HCl 200 MG Oral Tablet
- RxCUI: 1094104 - phenazopyridine hydrochloride 200 MG Oral Tablet
Phenazopyridine Hydrochloride Inactive Ingredients UNII Codes
- STARCH, CORN (UNII: O8232NY3SJ)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
- POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
- POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- TALC (UNII: 7SEV7J4R1U)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
* Please review the disclaimer below.
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.
* Please review the disclaimer below.
Phenazopyridine Hydrochloride Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
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:
Inactive Ingredients: Corn Starch, Croscarmellose Sodium, D&C Yellow #10 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, Microcrystalline Cellulose, Magnesium Stearate, Povidone, Polyvinyl Alcohol, Polyethylene Glycol, Pregelatinized Starch, Silicon Dioxide, Talc, and Titanium Dioxide.
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.)
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.
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).
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 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.
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.
NDC: 63629-2029-1 100 Tablets in a BOTTLE
Package Label.Principal Display Panel
Phenazopyridine Hcl 200 mg Tablet, #100
* Please review the disclaimer below.