NDC 75826-0114-10 — Phenazopyridine Hydrochloride 100 mg Tablet

🆔 Identity & classification

FDA NDC (as labeled) 75826-114-10

Product NDC 75826-114

11-digit billing NDC 75826011410

NCPDP billing unit EA — each (per item)

RxCUI 1094104, 1094107

UNII 0EWG668W17

UPC 0375826115109, 0375826114102

SPL Set ID 0a190e86-4074-4822-888e-4952281712ea

DEA schedule Non-controlled

Marketing category UNAPPROVED DRUG OTHER

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2015-12-23

Route ORAL

Dosage form TABLET

Substance PHENAZOPYRIDINE HYDROCHLORIDE

GPI-14 56300010100305

GPI class Phenazopyridine HCl

GCN Seq No 009477

GCN 42121

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 100 MG TAB

FDB brand name Phenazopyridine Hcl

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 75826-114-10 — 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 → 75826-0114-10. 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.

🏭 Manufacturer & labeler

LabelerWinder Laboratories, LLC

Labeler code75826

First marketedDec 2015

Product typeHuman Prescription Drug

Portfolio17 products on file

🔎 All NDCs from Winder Laboratories, LLC

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.

🩺 Clinical

Label name PHENAZOPYRIDINE 100 MG TAB Ingredient Phenazopyridine Hcl

📖 What it is MedlinePlus · NLM

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.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

No — and this is really important to understand. Phenazopyridine only relieves the pain, burning, and urgency. It does not kill the bacteria causing your infection. You still need...
Will phenazopyridine actually cure my UTI?
Yes, completely expected. Phenazopyridine turns urine — and sometimes tears, sweat, or other body fluids — a vivid orange or red color. It's harmless, but it can stain contact lens...
My urine turned bright orange — is that normal?

📖 Read our full Phenazopyridine guide →

Patient education

📘 MedlinePlus patient leaflet ↗

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.

💊 What it looks like

Color brown

ShapeRound

Imprint115

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.

💡 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 36SFW2JZ0W
Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
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 B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
UNII U725QWY32X
Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the 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.

8 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.

💲 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 system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$0.150	$15.00 / 100 tablets
Medicaid paysCMS SDUD · 12 mo	$0.7817	$78.17 / 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

▼ Down 49% over the last 24 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Phenazopyridine Hydrochloride 100 mg 65162-0681-10	Amneal	100 tablets	$0.150	—	Availability likely	—
Phenazopyridine Hydrochloride 100 mg 69367-0611-01	Westminster	100 tablets	$0.150	—	Availability likely	—
Phenazopyridine Hydrochloride 100 mgthis 75826-0114-10	Winder	100 tablets	$0.150	—	Availability likely	—
Phenazopyridine Hydrochloride 100 mg 50090-6442-00	A-S	10 tablets	—	—	FDA listed	—
Phenazopyridine Hydrochloride 100 mg 50090-7291-00	A-S	10 tablets	—	—	FDA listed	—
Phenazopyridine Hydrochloride 100 mg 51655-0007-27	Northwind	12 tablets	—	—	FDA listed	—
Pyridium 100 mg 60846-0501-01	Amneal	100 tablets	—	—	FDA listed	—
Phenazopyridine Hydrochloride 100 mg 62135-0403-60	Chartwell	60 tablets	—	—	FDA listed	—
Phenazopyridine Hydrochloride 100 mg 64950-0550-01	Genus	100 tablets	—	—	FDA listed	—
Phenazopyridine Hydrochloride 100 mg 67296-2206-06	Redpharm	6 tablets	—	—	FDA listed	—
Phenazopyridine Hydrochloride 100 mg 68071-2357-02	NuCare	12 tablets	—	—	FDA listed	—
Phenazopyridine Hydrochloride 100 mg 68071-5302-04	NuCare	4 tablets	—	—	FDA listed	—
Phenazopyridine Hydrochloride 100 mg 68788-7981-01	Preferred	15 tablets	—	—	FDA listed	—
Phenazopyridine Hydrochloride 100 mg 68788-8668-01	Preferred	15 tablets	—	—	FDA listed	—
Phenazopyridine Hydrochloride 100 mg 70518-0218-00	REMEDYREPACK	6 tablets	—	—	FDA listed	—
Phenazopyridine Hydrochloride 100 mg 70518-3443-00	REMEDYREPACK	30 tablets	—	—	Discontinued	—
Phenazopyridine Hydrochloride 100 mg 70518-3986-00	REMEDYREPACK	30 tablets	—	—	FDA listed	—
Phenazopyridine Hydrochloride 100 mg 71335-2323-01	Bryant	20 tablets	—	—	FDA listed	—
Phenazopyridine Hydrochloride 100 mg 71335-9712-01	Bryant	20 tablets	—	—	FDA listed	—
Phenazopyridine HCL 100 mg 72189-0534-06	Direct_Rx	6 tablets	—	—	FDA listed	—
Phenazopyridine Hydrochloride 100 mg 72789-0362-06	PD-Rx	6 tablets	—	—	FDA listed	—
Phenazopyridine Hydrochloride 100 mg 82804-0047-06	Proficient	6 tablets	—	—	FDA listed	—
Phenazopyridine Hydrochloride 100 mg 82804-0192-12	Proficient	12 tablets	—	—	FDA listed	—
Phenazopyridine Hydrochloride 100 mg 82804-0994-00	Proficient	100 tablets	—	—	FDA listed	—
Phenazopyridine Hydrochloride 100 mg 68071-5309-06	NuCare	6 tablets	—	—	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

🏛️

2015

On the market since

Dec 2015

📍

2026

Currently FDA-listed

11 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.

🗺️ 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 75826-0114-10, 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 – Q4 2025 · 4 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

62.7K

Units reimbursed last 4 qtrs

713.4K

Gross reimbursed last 4 qtrs

$557.7K

Avg / prescription

$8.90

Avg / unit

$0.7817

Latest quarter Q4 2025

14.3KRx

Medicaid pays / ea

$0.7817

gross reimbursed

vs

NADAC / ea

$0.1500

acquisition cost

=

Spread

+$0.6317

+421% 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 ⓘ

50% FFS 50% MCO

Fee-for-service · 31,445 Rx Managed care · 31,243 Rx

State Medicaid map

Units reimbursed · per 100k residents

9.0606

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 606 /100k

2 Kentucky 599 /100k

3 California 522 /100k

4 West Virginia 519 /100k

5 Ohio 412 /100k

6 New Mexico 367 /100k

7 Connecticut 366 /100k

8 Nevada 346 /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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
75826-0114-10 You're viewing this	100 TABLET in 1 BOTTLE, PLASTIC (75826-114-10)	2015-12-23	Active

🧭 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 FDA registers it as 75826-114-10, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 75826-0114-10, written without dashes as 75826011410. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 75826-0114-10, the first segment (75826) is the labeler code FDA assigned to Winder Laboratories, LLC; the middle segment (0114) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) identifies this exact package size and type. Together they name one specific package of one specific product.

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 Winder Laboratories, LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Winder Laboratories, 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description

🎯 Indications and Usage 174 words ▾

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.)

⏱️ Dosage and Administration 75 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 HCl should not exceed 2 days.

To report SUSPECTED ADVERSE REACTIONS, contact Winder Laboratories, LLC at 1-770-307-0703, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

⛔ Contraindications 28 words ▾

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 32 words ▾

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 120 words ▾

OVERDOSAGE Exceeding the recommended dose in patients with good renal function or administering the usual dose to patients with impaired renal function (common in elderly patients) may lead to increased serum levels and toxic reactions. Methemoglobinemia generally follows a massive, acute overdose. Methylene blue, 1 to 2 mg/kg/body weight intravenously or ascorbic acid 100 to 200 mg given orally should cause prompt reduction of the methemoglobinemia and disappearance of the cyanosis which is an aid in diagnosis.

Oxidative Heinz body hemolytic anemia may also occur, and "bite cells" (degmacytes) may be present in a chronic overdosage situation. Red blood cell G-6-PD deficiency may predispose to hemolysis. Renal and hepatic impairment and occasional failure, usually due to hypersensitivity, may also occur.

🧬 Clinical Pharmacology 74 words ▾

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.

📦 How Supplied / Storage and Handling 142 words ▾

HOW SUPPLIED 100 mg Tablets: Supplied in bottles of 100 (NDC 75826-114-10) counts. Appearance: Dark brown to maroon colored, round, film coated tablets debossed "114" on one side and plain on the other side. 200 mg Tablets: Supplied in bottles of 100 (NDC 75826-115-10) counts.

Appearance: Dark brown to maroon colored, round, film coated tablets debossed "115" on one side and plain on the other side. DISPENSE contents with a child-resistant closure (as required) and in a tight container as defined in the USP. STORE at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Disclaimer: This is not an Orange Book Product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. Manufactured by: Winder Laboratories, LLC.716 Patrick Industrial Lane Winder, GA 30680 RLS.115.99-2.0 Rev. Dec 2021

📋 Description 51 words ▾

DESCRIPTION Phenazopyridine Hydrochloride is dark brown fine granular powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. Phenazopyridine HCl tablets contain the following inactive ingredients: hypromellose, polyethylene glycol, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, maize(corn) starch, silicone dioxide, polyvinylpyrrolidone. image description

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

cyanosis: A bluish color of the skin, lips, or nails caused by too little oxygen in the blood.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

hemolysis: The breaking apart of red blood cells, which can lower the number of cells available to carry oxygen.

hemolytic anemia: A shortage of red blood cells caused by them breaking apart faster than the body can replace them.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

methemoglobinemia: A condition where the blood carries less oxygen than normal because of a change in its oxygen-carrying protein.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

pruritus: Itching of the skin.

topical: Applied onto the skin, eyes, or another body surface to work mainly where it is placed.

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

🔗 Related NDC lookups

🧪 All Phenazopyridine Hydrochloride NDCsSame ingredient 🏭 All Winder labeler NDCsLabeler code 75826

Phenazopyridine Hydrochloride 100 mg Tablet, 100-count

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

💊 What it looks like

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🗺️ Medicaid utilization & spend

📦 Packaging — all sizes for this product

🧭 About this NDC listing & data coverage

Listed without an FDA application

Questions about this listing

📄 Full prescribing information FDA SPL

🔗 Related NDC lookups