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Phenazopyridine Hydrochloride 200 mg Tablet, 9-count — NDC 50090-6952-07 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Phenazopyridine Hydrochloride 200 mg Tablet, 9-count — NDC 50090-6952-7 (Billing 50090-6952-07)

by A-S Medication Solutions · 9 TABLET in 1 BOTTLE

This is a package of 9 tablets of Phenazopyridine Hydrochloride 200 mg Tablet from A-S Medication Solutions, marketed since Oct 2023 and currently FDA-listed.

NDC 50090-6952-07
🏷️ FDA NDC (as labeled) 50090-6952-7 billing pads the package segment with a zero
This package
Contains9-count Pack sizes5 compare ↓
Product page 50090-6952-00 Also comes in: 6 tablets 50090-6952-4 10 tablets 50090-6952-0 12 tablets 50090-6952-6 15 tablets 50090-6952-1
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50090-6952-7
Product NDC 50090-6952
11-digit billing NDC 50090695207
NCPDP billing unit EA — each (per item)
RxCUI 1094104
UNII 0EWG668W17
SPL Set ID cd78a132-037c-412a-9c56-e38367e05c92
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-10-19
Route ORAL
Dosage form TABLET
Substance PHENAZOPYRIDINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 009478
GCN 42122
HICL code 004108
Ingredient (HICL) Phenazopyridine Hcl
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R5
Therapeutic class — intermediate (HIC2) Urinary Tract Anesthetic/Analgesic Agents
HIC3 code R5A
Therapeutic class — specific (HIC3) Urinary Tract Anesthetic/Analgesic Agnt (Azo-Dye)
AHFS code 84:08.00.00
AHFS class Antipruritics And Local Anesthetics
FDB label name PHENAZOPYRIDINE 200 MG TAB
FDB brand name Phenazopyridine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 009478
  • GCN: 42122
  • HICL (First Databank): 004108
  • AHFS class code: 84:08.00.00
  • RxCUI (RxNorm): 1094104
Why two NDCs? The FDA registers this code as 50090-6952-7 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 50090-6952-07. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Other urologicals class.

Drug family (ATC) Other urologicals
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name PHENAZOPYRIDINE 200 MG TAB Ingredient Phenazopyridine Hcl
📗 Our plain-language guide HelloPharmacist
  • It only helps with the pain — it doesn't kill the bacteria causing the infection. Think of it as taking the edge off while your antibiotic does the real work. If you have a UTI, yo...
  • Does phenazopyridine actually treat my UTI, or does it just help with the pain?
  • That's completely expected with phenazopyridine — it's one of the most common things people notice. The drug itself has an orange-red dye, and it passes into your urine, which is w...
  • Why is my urine turning orange or red? Should I be worried?
📖 Read our full Phenazopyridine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 6 tablets 10 tablets 12 tablets 15 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
50090-6952-00 50090-6952-0 Main listing 10 TABLET in 1 BOTTLE 2023-12-19 — Active
50090-6952-01 50090-6952-1 15 TABLET in 1 BOTTLE 2023-12-19 — Active
50090-6952-04 50090-6952-4 6 TABLET in 1 BOTTLE 2023-12-19 — Active
50090-6952-06 50090-6952-6 12 TABLET in 1 BOTTLE 2023-12-19 — Active
50090-6952-07 You're viewing this 9 TABLET in 1 BOTTLE 2023-12-19 — Active

You're viewing one of 5 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 9-count package — 9 tablet in 1 bottle.
How does this package differ from NDC 50090-6952-04?
Both are Phenazopyridine Hydrochloride 200 mg Tablet — the drug itself is identical. This page's package is the 9-count one, while NDC 50090-6952-04 is the 6 tablets package.
What NDC number is used to bill for this package of Phenazopyridine Hydrochloride 200 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Phenazopyridine Hydrochloride 200 mg 65162-0682-10 Amneal 100 tablets $0.176 — Availability likely —
Phenazopyridine Hydrochloride 200 mg 69367-0612-01 Westminster 100 tablets $0.176 — Availability likely —
Phenazopyridine Hydrochloride 200 mg 75826-0115-10 Winder 100 tablets $0.176 — Availability likely —
Pyridium 200 mg 60846-0502-01 Amneal 100 tablets $5.463 — Availability likely —
Phenazopyridine Hydrochloride 200 mg 50090-5876-00 A-S 10 tablets — — FDA listed —
Phenazopyridine Hydrochloride 200 mg 50090-5904-00 A-S 9 tablets — — FDA listed —
Phenazopyridine Hydrochloride 200 mg 50090-6951-00 A-S 9 tablets — — FDA listed —
Phenazopyridine Hydrochloride 200 mgthis 50090-6952-07 A-S 9 tablets — — FDA listed —
Phenazopyridine Hydrochloride 200 mg 51655-0424-27 Northwind 12 tablets — — FDA listed —
Phenazopyridine Hydrochloride 200 mg 62135-0404-60 Chartwell 60 tablets — — FDA listed —
Phenazopyridine Hydrochloride 200 mg 64950-0551-01 Genus 100 tablets — — FDA listed —
Phenazopyridine Hydrochloride 200 mg 68071-2479-01 NuCare 10 tablets — — FDA listed —
Phenazopyridine Hydrochloride 200 mg 68788-7902-01 Preferred 15 tablets — — FDA listed —
Phenazopyridine Hydrochloride 200 mg 68788-8695-01 Preferred 15 tablets — — FDA listed —
Phenazopyridine Hydrochloride 200 mg 70518-3868-00 REMEDYREPACK 9 tablets — — Discontinued —
Phenazopyridine Hydrochloride 200 mg 70518-3975-00 REMEDYREPACK 30 tablets — — FDA listed —
Phenazopyridine Hydrochloride 200 mg 71205-0813-06 Proficient 6 tablets — — FDA listed —
Phenazopyridine Hydrochloride 200 mg 71335-2321-01 Bryant 9 tablets — — FDA listed —
Phenazopyridine Hydrochloride 200 mg 71335-2750-01 Bryant 9 tablets — — FDA listed —
Phenazopyridine Hydrochloride 200 mg 72162-2540-01 Bryant 100 tablets — — FDA listed —
Phenazopyridine HCL 200 mg 72189-0530-06 Direct 6 tablets — — FDA listed —
Phenazopyridine Hydrochloride 200 mg 72789-0288-09 PD-Rx 9 tablets — — FDA listed —
Phenazopyridine Hydrochloride 200 mg 82804-0125-06 Proficient 6 tablets — — FDA listed —
Phenazopyridine Hydrochloride 200 mg 82804-0995-00 Proficient 100 tablets — — FDA listed —
Phenazopyridine Hydrochloride 200 mg 83939-0021-01 VERITYRX, 1 tablet — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Brown
ShapeRound
Imprint612
Size1 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerA-S Medication Solutions
Labeler code50090
First marketedOct 2023
Product typeHuman Prescription Drug
Portfolio2,811 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 152 words ▾

INDICATIONS AND USAGE Phenazopyridine Hydrochloride is indicated for the symptomatic relief of pain, burning, urgency frequency, and other discomforts arising from irritation of the mucosa of the lower urinary tract caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine Hydrochloride for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. The drug should be used for symptomatic relief of pain and not as a substitute for specific surgery or antimicrobial therapy.

Phenazopyridine Hydrochloride is compatible with antimicrobial therapy and can help relieve pain and discomfort during the interval before antimicrobial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine Hydrochloride should not exceed 2 days. There is no evidence that the combined administration of Phenazopyridine Hydrochloride and an antimicrobial provides greater benefit than administration of the antimicrobial alone after 2 days.

(See Dosage and Administration .)

⏱️ Dosage and Administration 58 words ▾

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 Hydrochloride should not exceed 2 days.

⛔ Contraindications 47 words ▾

CONTRAINDICATIONS Phenazopyridine Hydrochloride should not be used in patients who are hypersensitive to the drug or its ingredients. Phenazopyridine Hydrochloride is contraindicated in patients with renal insufficiency, severe liver disease, severe hepatitis or pyelonephritis of pregnancy. It should be used cautiously in the presence of GI disturbances.

⚠️ Warnings 101 words ▾

WARNINGS Phenazopyridine Hydrochloride is reasonably anticipated to be a human carcinogen based on sufficient evidence of carcinogenicity in experimental animals (IARC 1980, 1982, 1987, NCI 1978). When administered in the diet, Phenazopyridine hydrochloride increased the incidences of hepatocellular adenomas and carcinomas in female mice and adenomas and adenocarcinomas of the colon and rectum in rats of both sexes. There is inadequate evidence for the carcinogenicity of Phenazopyridine hydrochloride in humans (TARC 1987).

In one limited epidemiological study, no significant excess of any cancer was observed among 2,214 patients who received Phenazopyridine hydrochloride and were followed for a minimum of 3 years.

🤒 Adverse Reactions 59 words ▾

ADVERSE REACTIONS The following adverse events have been reported: CNS: headache. Gastrointestinal: nausea, vomiting and diarrhea. Dermatologic and Hypersensitivity: rash, pruritus, discoloration, anaphylactoid-like reaction and hypersensitivity hepatitis.

Hematologic: methemoglobinemia, hemolytic anemia, potential hemolytic agent in G-6-PD deficiency, sulfhemoglobinemia. Other: visual disturbances, renal and hepatic toxicity usually associated with overdose, renal calculi, jaundice, discoloration of body fluids and aseptic meningitis.

🔄 Drug Interactions 32 words ▾

Drug Interactions The interaction of Phenazopyridine Hydrochloride with other drugs has not been studied in a systematic manner. However, the medical literature to date suggests that no significant interactions have been reported.

🤰 Pregnancy 79 words ▾

Pregnancy Category B Reproductive studies with Phenazopyridine Hydrochloride (in combination with sulfacytine) in rats given up to 110 mg/kg/day and in rabbits given up to 39 mg/kg/day during organogenesis revealed no evidence of harm to offspring. One prospective study in humans demonstrated that Phenazopyridine Hydrochloride traverses the placenta into the fetal compartment. There are no adequate and well-controlled studies in pregnant women.

Therefore, Phenazopyridine Hydrochloride should be used in pregnant women only if the benefit clearly outweighs the risk.

🧒 Pediatric Use 19 words ▾

Children Adequate and well-controlled studies have not been performed in the pediatric population. No pediatric-specific problems have been documented.

🧬 Clinical Pharmacology 95 words ▾

CLINICAL PHARMACOLOGY Phenazopyridine hydrochloride 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 unknown.

PHARMACOKINETICS The pharmacokinetic properties of Phenazopyridine hydrochloride have not been determined. Phenazopyridine Hydrochloride and its metabolites are rapidly excreted by the kidneys. In a small number of healthy subjects, 90% of a 600 mg/day oral dose of Phenazopyridine hydrochloride was eliminated in the urine in 24 hours, 41% as unchanged drug and 49% as metabolites.

📦 How Supplied / Storage and Handling 39 words ▾

HOW SUPPLIED Product: 50090-6952 NDC: 50090-6952-0 10 TABLET in a BOTTLE NDC: 50090-6952-1 15 TABLET in a BOTTLE NDC: 50090-6952-4 6 TABLET in a BOTTLE NDC: 50090-6952-6 12 TABLET in a BOTTLE NDC: 50090-6952-7 9 TABLET in a BOTTLE

📋 Description 90 words ▾

DESCRIPTION Phenazopyridine Hydrochloride is a reddish-brown, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. Following is the structural formula: C 11 H 11 N 5 ∙ HCl M.W.

249.70 Phenazopyridine Hydrochloride oral tablets contain the following inactive ingredients: Croscarmellose Sodium, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Povidone, Pregelatinized Starch, Talc, and Titanium Dioxide. Chemical Structure

💬 Information for Patients 129 words ▾

Information for Patients The patient should be advised to take Phenazopyridine Hydrochloride with or following food or after eating a snack to reduce stomach upset. The patients should be aware that Phenazopyridine Hydrochloride causes a reddish orange discoloration of the urine and feces, and may stain clothing. Phenazopyridine Hydrochloride may cause discoloration of body fluids and staining of contact lenses has been reported.

There have been reports of teeth discoloration when the product has been broken or held in the mouth prior to swallowing. Patients should be instructed to take Phenazopyridine Hydrochloride for only 2 days if an antibacterial agent is administered concurrently for the treatment of a urinary tract infection. If symptoms persist beyond those 2 days, the patient should be instructed to contact his or her physician.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General The patient should be advised that Phenazopyridine Hydrochloride produces an orange to red color in the urine and feces, and may cause staining. Phenazopyridine Hydrochloride may cause discoloration of body fluids and staining of contact lenses has been reported. A yellowish color of the skin or sclera may indicate accumulation of Phenazopyridine Hydrochloride resulting from impaired renal function and necessitates discontinuance of the drug.

It should be noted that a decline in renal function is common in elderly patients. Phenazopyridine Hydrochloride may mask pathological conditions and interfere with laboratory test values using colorimetric, spectrophotometric or fluorometric analysis methods. Cautious use in patients with G-6-PD deficiency is advised since these patients are susceptible to oxidative hemolysis and may have greater potential to develop hemolytic anemia.

Information for Patients The patient should be advised to take Phenazopyridine Hydrochloride with or following food or after eating a snack to reduce stomach upset. The patients should be aware that Phenazopyridine Hydrochloride causes a reddish orange discoloration of the urine and feces, and may stain clothing. Phenazopyridine Hydrochloride may cause discoloration of body fluids and staining of contact lenses has been reported.

There have been reports of teeth discoloration when the product has been broken or held in the mouth prior to swallowing. Patients should be instructed to take Phenazopyridine Hydrochloride for only 2 days if an antibacterial agent is administered concurrently for the treatment of a urinary tract infection. If symptoms persist beyond those 2 days, the patient should be instructed to contact his or her physician.

Laboratory Tests Phenazopyridine Hydrochloride may interfere with laboratory test values using colorimetric, photometric or fluorometric analysis methods. Altered urine laboratory test values may include ketone (sodium nitroprusside) bilirubin (foam test, talc-disk-Fouchet-spot test, Franklin's tablet-Fouchet test, p-nitrobenzene diazonium p-toluene sulfonate reagent), diacetic acid (Gerhardt ferric chloride test), free hydrochloric acid, glucose (glucose oxidase tests), 17-hydroxycorticosteroids (modified Glenn-Nelson), 17-ketosteroids (Holtorff Koch modification of Zimmerman), porphyrins, albumin (discolors bromophenol blue test areas of commercial reagent strips, nitric acid ring test), phenolsulfophthalein, urobilinogen (color interference with Ehrlich's reagent), and urinalysis (spectrophotometric or color-based tests).

Phenazopyridine Hydrochloride also imparts an orange-red color to stools which may interfere with color tests. Drug Interactions The interaction of Phenazopyridine Hydrochloride with other drugs has not been studied in a systematic manner. However, the medical literature to date suggests that no significant interactions have been reported.

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term administration of Phenazopyridine Hydrochloride has been associated with tumors of the large intestine in rats and of the liver in mice. Available epidemiological data are insufficient to evaluate the carcinogenicity of Phenazopyridine Hydrochloride in humans. In vitro studies indicate that Phenazopyridine Hydrochloride in the presence of metabolic activation is mutagenic in bacteria and mutagenic and clastogenic in mammalian cells.

Pregnancy Category B Reproductive studies with Phenazopyridine Hydrochloride (in combination with sulfacytine) in rats given up to 110 mg/kg/day and in rabbits given up to 39 mg/kg/day during organogenesis revealed no evidence of harm to offspring. One prospective study in humans demonstrated that Phenazopyridine Hydrochloride traverses the placenta into the fetal compartment. There are no adequate and well-controlled studies in pregnant women.

Therefore, Phenazopyridine Hydrochloride should be used in pregnant women only if the benefit clearly outweighs the… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 49 words ▾

Nursing Mothers It is not known whether Phenazopyridine Hydrochloride or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of drug therapy to the mother.

🧬 Pharmacokinetics 55 words ▾

PHARMACOKINETICS The pharmacokinetic properties of Phenazopyridine hydrochloride have not been determined. Phenazopyridine Hydrochloride and its metabolites are rapidly excreted by the kidneys. In a small number of healthy subjects, 90% of a 600 mg/day oral dose of Phenazopyridine hydrochloride was eliminated in the urine in 24 hours, 41% as unchanged drug and 49% as metabolites.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 65 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term administration of Phenazopyridine Hydrochloride has been associated with tumors of the large intestine in rats and of the liver in mice. Available epidemiological data are insufficient to evaluate the carcinogenicity of Phenazopyridine Hydrochloride in humans. In vitro studies indicate that Phenazopyridine Hydrochloride in the presence of metabolic activation is mutagenic in bacteria and mutagenic and clastogenic in mammalian cells.

📄 Package Label / Principal Display Panel 4 words ▾

Phenazopyridine Hydrochloride Label Image

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Phenazopyridine Hydrochloride — the ingredient across all brands.

Top reported reactions

Pain35
Dyspnoea33
Nausea32
Headache29
Fatigue27
Sulphaemoglobinaemia27
Urinary Tract Infection25

Age at onset

Adolescent2
Adult37
Elderly34

Reporter sex

325 reports

Serious outcomes

Hospitalization148
Life-threatening42
Death19
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 67 15
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by A-S Medication Solutions. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 6 tablets (50090-6952-04), 10 tablets (50090-6952-00), 12 tablets (50090-6952-06). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
A-S Medication Solutions is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 50090-6951-00 · A-S 50090-6957-01 · A-S →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.