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Phenazopyridine Hydrochloride 200 mg Tablet, 100-count — NDC 75826-0115-10 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 75826-115-10 (Billing 75826-0115-10)

by Winder Laboratories, LLC · 100 TABLET in 1 BOTTLE, PLASTIC

This is a package of 100 tablets of Phenazopyridine Hydrochloride 200 mg Tablet from Winder Laboratories, LLC, marketed since Nov 2015 and currently FDA-listed; retail pharmacies pay about $0.1760 per tablet (NADAC). It is this product's only package size.

NDC 75826-0115-10
🏷️ FDA NDC (as labeled) 75826-115-10 billing pads the product segment with a zero
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

Past resolved recalls for this product (1)
Class II · May 28, 2024 · Completed — Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg. (Winder Laboratories, LLC) · FDA recall D-0545-2024

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 75826-115-10
Product NDC 75826-115
11-digit billing NDC 75826011510
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 2015-11-23
Route ORAL
Dosage form TABLET
Substance PHENAZOPYRIDINE HYDROCHLORIDE

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

GPI-14 56300010100310
GPI class Phenazopyridine HCl
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 75826-115-10 — 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 → 75826-0115-10. 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.

Clinical

Label name PHENAZOPYRIDINE 200 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
  • 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 $0.9954 $99.54 / 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
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.624 $0.169
▼ Down 61% 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
75826-0115-10 You're viewing this Main listing 100 TABLET in 1 BOTTLE, PLASTIC 2015-11-23 — Active

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 mgthis 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

🏛️
2015
On the market since
Nov 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.

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.

Manufacturer & labeler

LabelerWinder Laboratories, LLC
Labeler code75826
First marketedNov 2015
Product typeHuman Prescription Drug
Portfolio17 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. 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 ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 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

⚠️ Precautions ~1 min read ▾

PRECAUTIONS General: A yellowish tinge of the skin or sclera may indicate accumulation due to impaired renal excretion and the need to discontinue therapy. The decline in renal function associated with advanced age should be kept in mind. While our product does not contain Sulfur, it has been indicated to exhibit in rare circumstances a sulfur-type reaction.

Use of this product in patients sensitive to sulfur should be done so under the supervision of a Physician. NOTE : Patients should be informed that Phenazopyridine HCl produces a reddish-orange discoloration of the urine and may stain fabric. Staining of contact lenses has been reported.

Laboratory Test Interaction: Due to its properties as an azo dye, Phenazopyridine HCl may interfere with urinalysis based on spectrometry or color reactions. Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term administration of Phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.

Pregnancy Category B: Reproduction studies have been performed in rats at doses up to 50 mg/kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to Phenazopyridine HCl. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing mothers: No information is available on the appearance of Phenazopyridine HCl, or its metabolites in human milk.

📄 Package Label / Principal Display Panel 6 words ▾

phenazo 100 mg phenazo 200 mg

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
98K
Units reimbursed last 4 qtrs
881.2K
Gross reimbursed last 4 qtrs
$877.1K
Avg / prescription
$8.95
Avg / unit
$0.9954
Latest quarter Q1 2026
23.3KRx
Medicaid pays / ea
$0.9954
gross reimbursed
vs
NADAC / ea
$0.1760
acquisition cost
=
Spread
+$0.8194
+466% 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 ⓘ
51% FFS 49% MCO
Fee-for-service · 49,516 Rx Managed care · 48,488 Rx
State Medicaid map
Alaska: no data reported AK Maine: 1,896 units · 136 per 100k residents ME Washington: 10,075 units · 129 per 100k residents WA Idaho: 2,870 units · 146 per 100k residents ID Montana: 1,977 units · 175 per 100k residents MT North Dakota: 79 units · 10.1 per 100k residents ND Minnesota: 6,866 units · 120 per 100k residents MN Wisconsin: 10,064 units · 170 per 100k residents WI Michigan: 35,720 units · 356 per 100k residents MI New York: 62,365 units · 319 per 100k residents NY Vermont: 1,359 units · 210 per 100k residents VT New Hampshire: 1,376 units · 98.1 per 100k residents NH Oregon: 2,775 units · 65.6 per 100k residents OR Nevada: 12,060 units · 378 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 3,973 units · 124 per 100k residents IA Illinois: 26,457 units · 211 per 100k residents IL Indiana: 11,089 units · 162 per 100k residents IN Ohio: 66,909 units · 568 per 100k residents OH Pennsylvania: 43,495 units · 336 per 100k residents PA New Jersey: 23,475 units · 253 per 100k residents NJ Massachusetts: 11,490 units · 164 per 100k residents MA California: 262,900 units · 675 per 100k residents CA Utah: 1,760 units · 51.5 per 100k residents UT Colorado: 10,530 units · 179 per 100k residents CO Nebraska: 4,196 units · 212 per 100k residents NE Missouri: 14,338 units · 231 per 100k residents MO Kentucky: 27,056 units · 598 per 100k residents KY West Virginia: no data reported WV Virginia: 9,117 units · 105 per 100k residents VA Maryland: 16,324 units · 264 per 100k residents MD Connecticut: 11,514 units · 318 per 100k residents CT Rhode Island: 878 units · 80.2 per 100k residents RI Arizona: 26,018 units · 350 per 100k residents AZ New Mexico: 8,389 units · 397 per 100k residents NM Kansas: 1,967 units · 66.9 per 100k residents KS Arkansas: 1,454 units · 47.4 per 100k residents AR Tennessee: 23,659 units · 332 per 100k residents TN North Carolina: 18,026 units · 166 per 100k residents NC South Carolina: 4,271 units · 79.5 per 100k residents SC Delaware: 4,631 units · 449 per 100k residents DE Oklahoma: no data reported OK Louisiana: 37,791 units · 826 per 100k residents LA Mississippi: no data reported MS Alabama: 7,669 units · 150 per 100k residents AL Georgia: 5,033 units · 45.6 per 100k residents GA D.C.: 706 units · 104 per 100k residents DC Hawaii: 6,878 units · 479 per 100k residents HI Texas: no data reported TX Florida: 37,952 units · 168 per 100k residents FL
Units reimbursed · per 100k residents
10.1826
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 826 /100k
2 California 675 /100k
3 Kentucky 598 /100k
4 Ohio 568 /100k
5 Hawaii 479 /100k
6 Delaware 449 /100k
7 New Mexico 397 /100k
8 Nevada 378 /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 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.
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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.