Home › NDC Lookup › Ingredients › Phenazopyridine Hydrochloride › 69367-0612-01
Phenazopyridine Hydrochloride 200 mg Tablet, 100-count — NDC 69367-0612-01 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, 100-count — NDC 69367-612-01 (Billing 69367-0612-01)

by Westminster Pharmaceuticals, LLC · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Phenazopyridine Hydrochloride 200 mg Tablet from Westminster Pharmaceuticals, LLC, marketed since Oct 2023 and currently FDA-listed; retail pharmacies pay about $0.1760 per tablet (NADAC). It is this product's only package size.

NDC 69367-0612-01
🏷️ FDA NDC (as labeled) 69367-612-01 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 69367-612-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
69367 labeler · 612 product · 01 package
Package marketed since
Oct 19, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
100 EA per package
Barcode (UPC-A, from the NDC)
3 6936761201 2
Medicaid fills, this package
21,750 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69367-612-01
Product NDC 69367-612
11-digit billing NDC 69367061201
NCPDP billing unit EA — each (per item)
RxCUI 1094104, 1094107
UNII 0EWG668W17
SPL Set ID 20681450-859a-45b0-825c-760cbbd95ac6
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

GPI-14 56300010100310
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
  • GPI-14 (Medi-Span): 56300010100310
  • HICL (First Databank): 004108
  • AHFS class code: 84:08.00.00
  • RxCUI (RxNorm): 1094104
Why two NDCs? The FDA registers this code as 69367-612-01 — a 5-3-2 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 product segment → 69367-0612-01. 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 eaPer package
Retail pharmacies payNADAC · weekly $0.176 $17.60 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $1.00 $100.21 / 100 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Feb 2024 Feb 2026 May 2026 Sep 2026 $0.217 $0.169
▼ Down 19% over the last 11 months.
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
69367-0612-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE 2023-10-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Phenazopyridine Hydrochloride 200 mg 65162-0682-10 Amneal 100 tablets $0.176 — Availability likely —
Phenazopyridine Hydrochloride 200 mgthis 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 +3005%
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 mg 50090-6952-00 A-S 10 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.

🧪 Avoiding an ingredient? See Phenazopyridine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

14 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerWestminster Pharmaceuticals, LLC
Labeler code69367
First marketedOct 2023
Product typeHuman Prescription Drug
Portfolio186 products on file

More NDCs from Westminster Pharmaceuticals, LLC labeler code 69367

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 📦 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 122 words ▾

HOW SUPPLIED 100 mg Tablets: Supplied in bottles of 100ct (NDC 69367-611-01) Appearance: Dark brown coated, round standard cup tablet, debossed "611" on one side and plain on the other. 200 mg Tablets: Supplied in bottles of 100ct (NDC 69367-612-01) Appearance: Dark brown coated, round standard cup tablet, debossed "612" 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) with excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. To report an adverse reaction, please contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

📦 Storage and Handling 46 words ▾

STORE at 20° to 25°C (68° to 77°F) with excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. To report an adverse reaction, please contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

📋 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 64 words ▾

PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label NDC 69367-611-01 Rx Only Phenazopyridine Hydrochloride Tablets, USP 100 mg 100 Tablets Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Label NDC 69367-612-01 Rx Only Phenazopyridine Hydrochloride Tablets, USP 200 mg 100 Tablets Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
21.8K
Units reimbursed last 4 qtrs
196.2K
Gross reimbursed last 4 qtrs
$196.6K
Avg / prescription
$9.04
Avg / unit
$1.0021
Latest quarter Q1 2026
5.5KRx
Medicaid pays / ea
$1.0021
gross reimbursed
vs
NADAC / ea
$0.1760
acquisition cost
=
Spread
+$0.8261
+469% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
26% FFS 74% MCO
Fee-for-service · 5,596 Rx Managed care · 16,154 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 1,235 units · 15.8 per 100k residents WA Idaho: 179 units · 9.1 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 981 units · 17.1 per 100k residents MN Wisconsin: 2,017 units · 34.1 per 100k residents WI Michigan: 10,765 units · 107 per 100k residents MI New York: 11,912 units · 60.9 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 657 units · 20.6 per 100k residents NV Wyoming: no data reported WY South Dakota: 500 units · 54.4 per 100k residents SD Iowa: 418 units · 13.0 per 100k residents IA Illinois: 1,161 units · 9.3 per 100k residents IL Indiana: 297 units · 4.3 per 100k residents IN Ohio: 15,279 units · 130 per 100k residents OH Pennsylvania: 8,486 units · 65.5 per 100k residents PA New Jersey: 4,078 units · 43.9 per 100k residents NJ Massachusetts: 194 units · 2.8 per 100k residents MA California: 22,043 units · 56.6 per 100k residents CA Utah: 193 units · 5.6 per 100k residents UT Colorado: 420 units · 7.1 per 100k residents CO Nebraska: 1,519 units · 76.8 per 100k residents NE Missouri: 2,286 units · 36.9 per 100k residents MO Kentucky: 8,592 units · 190 per 100k residents KY West Virginia: 4,379 units · 247 per 100k residents WV Virginia: 7,057 units · 81.0 per 100k residents VA Maryland: 7,193 units · 116 per 100k residents MD Connecticut: 922 units · 25.5 per 100k residents CT Rhode Island: no data reported RI Arizona: 957 units · 12.9 per 100k residents AZ New Mexico: 624 units · 29.5 per 100k residents NM Kansas: 104 units · 3.5 per 100k residents KS Arkansas: 132 units · 4.3 per 100k residents AR Tennessee: 4,334 units · 60.8 per 100k residents TN North Carolina: 4,841 units · 44.7 per 100k residents NC South Carolina: 2,219 units · 41.3 per 100k residents SC Delaware: 131 units · 12.7 per 100k residents DE Oklahoma: no data reported OK Louisiana: 20,546 units · 449 per 100k residents LA Mississippi: no data reported MS Alabama: 2,716 units · 53.2 per 100k residents AL Georgia: 4,230 units · 38.4 per 100k residents GA D.C.: no data reported DC Hawaii: 246 units · 17.1 per 100k residents HI Texas: no data reported TX Florida: 7,203 units · 31.9 per 100k residents FL
Units reimbursed · per 100k residents
2.8449
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Louisiana 449 /100k
2 West Virginia 247 /100k
3 Kentucky 190 /100k
4 Ohio 130 /100k
5 Maryland 116 /100k
6 Michigan 107 /100k
7 Virginia 81.0 /100k
8 Nebraska 76.8 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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) ✓ Available
NADAC pharmacy acquisition price (CMS) ✓ Available
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) ✓ Available
“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.
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 Westminster Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Westminster Pharmaceuticals, LLC 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.
← 69367-0611-01 · Westminster 69367-0615-01 · Westminster →
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.