Pyridium
Phenazopyridine
Amneal Pharmaceuticals Llc
Human Prescription Drug
NDC 60846-501Pyridium also known as Phenazopyridine is a human prescription drug labeled by 'Amneal Pharmaceuticals Llc'. National Drug Code (NDC) number for Pyridium is 60846-501. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Pyridium drug includes Phenazopyridine Hydrochloride - 100 mg/1 . The currest status of Pyridium drug is Active.
Drug Information:
| Drug NDC: | 60846-501 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Pyridium |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Phenazopyridine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Amneal Pharmaceuticals Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Film Coated |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | PHENAZOPYRIDINE HYDROCHLORIDE - 100 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Jan, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 Dec, 2025 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Amneal Pharmaceuticals LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1094104
1094107
1094109
1094122
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 0EWG668W17
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 60846-501-01 | 100 TABLET, FILM COATED in 1 BOTTLE (60846-501-01) | 01 Jan, 2014 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Pyridium phenazopyridine phenazopyridine hydrochloride phenazopyridine carnauba wax croscarmellose sodium hypromelloses magnesium stearate cellulose, microcrystalline polyethylene glycol, unspecified povidone starch, corn deep brown to maroon colored py;1 pyridium phenazopyridine phenazopyridine hydrochloride phenazopyridine carnauba wax croscarmellose sodium hypromelloses magnesium stearate cellulose, microcrystalline polyethylene glycol, unspecified povidone starch, corn deep brown to maroon colored py;2
Indications and Usage:
Indications and usage pyridium 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 two days because there is a lack of evidence
Read more... that the combined administration of phenazopyridine hcl and an antibacterial provides greater benefit than administration of the antibacterial alone after two days. (see dosage and administration section.)
General 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.
Dosage and Administration:
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.
Contraindications:
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:
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).
Overdosage:
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 âbite cellsâ (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.
Description:
Description pyridium ® (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: c 11 h 11 n 5 â¢hcl m.w. 249.70 pyridium (phenazopyridine hcl tablets, usp) contains the following inactive ingredients: carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and pregelatinized starch. structural formula
Clinical Pharmacology:
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.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
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.
How Supplied:
How supplied 100 mg tablets: supplied in bottles of 100 (ndc 60846-501-01) counts. appearance: deep brown to maroon colored, round, film coated tablets debossed âpyâ above â1â on one side and plain on the other. 200 mg tablets: supplied in bottles of 100 (ndc 60846-502-01) counts. appearance: deep brown to maroon colored, round, film coated tablets debossed âpyâ above â2â 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 between 15° to 30°c (59° to 86°f) [see usp controlled room temperature]. manufactured for: amneal specialty, a division of amneal pharmaceuticals llc bridgewater, nj 08807 rev. 03-2019-00
Package Label Principal Display Panel:
Principal display panel 100mg label
200mg label