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Phenazopyridine Hydrochloride 100 mg Tablet, 21-count — NDC 71335-9712-08 package photo

Phenazopyridine Hydrochloride 100 mg Tablet, 21-count

by Bryant Ranch Prepack · 21 TABLET in 1 BOTTLE (71335-9712-8)
NDC 71335-9712-08
🏷️ FDA NDC (as labeled) 71335-9712-8 billing pads the package segment with a zero
This package
Contains21-count Pack sizes9 compare ↓
Also comes in: 6 tablets 71335-9712-07 9 tablets 71335-9712-03 10 tablets 71335-9712-04 12 tablets 71335-9712-02 15 tablets 71335-9712-05 20 tablets 71335-9712-01 30 tablets 71335-9712-09 100 tablets 71335-9712-06
Rx only On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 71335-9712-8
Product NDC 71335-9712
11-digit billing NDC 71335971208
RxCUI 1094107
UNII 0EWG668W17
SPL Set ID 7367afd6-6bf6-4240-a274-79b7a5de9715
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-02-01
Route ORAL
Dosage form TABLET
Substance PHENAZOPYRIDINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 71335-9712-8 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 71335-9712-08. 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

LabelerBryant Ranch Prepack
Labeler code71335
First marketedFeb 2011
Product typeHuman Prescription Drug
Portfolio4,433 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.

🩺 Clinical

📖 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 →
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
ImprintPY;1
Size1 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 6 tablets 9 tablets 10 tablets 12 tablets 15 tablets 20 tablets 30 tablets 100 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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 mg 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 mgthis 71335-9712-08 Bryant 21 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 71335-2014-01 Bryant 20 tablets — — Discontinued —
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

🏛️
2011
On the market since
Feb 2011
📍
2026
Currently FDA-listed
15 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.

🔬 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 (this brand).

Top reported reactions

Chronic Kidney Disease325
Acute Kidney Injury206
Renal Failure184
Pain177
Nausea169
Fatigue156
Urinary Tract Infection152

Reporter sex

2,299 reports
Male · 27%
Female · 73%
Unknown · 0%

Serious outcomes

Hospitalization814
Death179
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 219 0
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71335-9712-01 20 TABLET in 1 BOTTLE (71335-9712-1) 2023-05-25 Active
71335-9712-02 12 TABLET in 1 BOTTLE (71335-9712-2) 2023-05-25 Active
71335-9712-03 9 TABLET in 1 BOTTLE (71335-9712-3) 2023-05-25 Active
71335-9712-04 10 TABLET in 1 BOTTLE (71335-9712-4) 2023-05-25 Active
71335-9712-05 15 TABLET in 1 BOTTLE (71335-9712-5) 2023-05-25 Active
71335-9712-06 100 TABLET in 1 BOTTLE (71335-9712-6) 2023-05-25 Active
71335-9712-07 6 TABLET in 1 BOTTLE (71335-9712-7) 2023-05-25 Active
71335-9712-08 You're viewing this 21 TABLET in 1 BOTTLE (71335-9712-8) 2023-05-25 Active
71335-9712-09 30 TABLET in 1 BOTTLE (71335-9712-9) 2023-05-25 Active

You're viewing one of 9 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71335-9712-08?
NDC 71335-9712-08 is a 21-count package — 21 tablet in 1 bottle.
What is the difference between NDC 71335-9712-08 and NDC 71335-9712-07?
Both are Phenazopyridine Hydrochloride 100 mg Tablet — the drug itself is identical. NDC 71335-9712-08 is the 21-count package, while NDC 71335-9712-07 is the 6 tablets package.
What NDC number is used to bill for this package of Phenazopyridine Hydrochloride 100 mg Tablet?
Bill NDC 71335-9712-08 — the 11-digit billing format is 71335971208. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

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

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

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 71335-9712-8, 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: 71335-9712-08, written without dashes as 71335971208. 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 71335-9712-08, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (9712) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) 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 Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 8 other package presentations of this same product, including 6 tablets (71335-9712-07), 9 tablets (71335-9712-03), 10 tablets (71335-9712-04). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Bryant Ranch Prepack 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 🤰 Pregnancy 🆘 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 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 HCl should not exceed 2 days.

⛔ 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 48 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). To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 65 words ▾

Pregnancy 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.

🆘 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 Phenazopyridine HCl tablets, USP 100 mg are available as deep brown to maroon colored, round, film-coated tablets debossed “PY” above “1” on one side and plain on the other. NDC 71335-9712-1: 20 Tablets in a BOTTLE NDC 71335-9712-2: 12 Tablets in a BOTTLE NDC 71335-9712-3: 9 Tablets in a BOTTLE NDC 71335-9712-4: 10 Tablets in a BOTTLE NDC 71335-9712-5: 15 Tablets in a BOTTLE NDC 71335-9712-6: 100 Tablets in a BOTTLE NDC 71335-9712-7: 6 Tablets in a BOTTLE NDC 71335-9712-8: 21 Tablets in a BOTTLE NDC 71335-9712-9: 30 Tablets in a BOTTLE 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 between15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

📋 Description 71 words ▾

DESCRIPTION Phenazopyridine Hydrochloride, USP is light or dark red to dark violet, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. It has the following structural formula: C 11 H 11 N 5 •HCl M.W.

249.70 Phenazopyridine HCl tablets, USP contain the following inactive ingredients: carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71335-9711-01 · Bryant 71335-9713-01 · Bryant →
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.