HomeNDC LookupIngredientsFlavoxate Hydrochloride › 00574-0115-01
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FLAVOXATE HYDROCHLORIDE 100 mg Tablet, Film Coated, 100-count

by Padagis US LLC · 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0574-0115-01)
NDC 00574-0115-01
🏷️ FDA NDC (as labeled) 0574-0115-01 billing pads the labeler segment with a zero
Rx only Generic 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 →

🆔 Identity & classification

FDA NDC (as labeled) 0574-0115-01
Product NDC 0574-0115
11-digit billing NDC 00574011501
NCPDP billing unit EA — each (per item)
RxCUI 1095229
UNII 9C05J6089W
UPC 0305740115015
Application # ANDA076831
SPL Set ID a9c44c4b-5b3c-45bf-9bc9-ce858e3d06c5
Established class (EPC) Cholinergic Muscarinic Antagonist
Mechanism of action Cholinergic Muscarinic Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2004-12-22
Marketing end 2026-12-31
Route ORAL
Dosage form TABLET, FILM COATED
Substance FLAVOXATE HYDROCHLORIDE
GPI-14 54400025100310
GPI class flavoxATE HCl
GCN Seq No 004927
GCN 19360
HICL code 002047
Ingredient (HICL) Flavoxate Hcl
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1A
Therapeutic class — specific (HIC3) Urinary Tract Antispasmodic/Antiincontinence Agent
AHFS code 86:12.04.00
AHFS class Antimuscarinics
FDB label name FLAVOXATE HCL 100 MG TABLET
FDB brand name Flavoxate Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0574-0115-01 — a 4-4-2 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 labeler segment → 00574-0115-01. 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 Cholinergic Muscarinic Antagonist class.

Pharmacologic class Cholinergic Muscarinic Antagonist
Drug family (ATC) Drugs for urinary frequency and incontinence
How it works Cholinergic Muscarinic Antagonists
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

LabelerPadagis US LLC
Application holderPADAGIS US LLC
FDA applicationANDA076831 (ANDA)
Labeler code00574
First marketedDec 2004
Product typeHuman Prescription Drug
Portfolio63 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

Label name FLAVOXATE HCL 100 MG TABLET Ingredient Flavoxate Hcl
📗 Our plain-language guide HelloPharmacist
  • No — and that's an important distinction. Flavoxate is a symptom reliever, not an antibiotic. It helps calm the spasms in your urinary tract that cause the burning, urgency, and fr...
  • Will flavoxate actually cure my bladder infection?
  • In a clinical study, flavoxate started working in about 55 minutes, with the strongest effect hitting around the 112-minute mark — so roughly two hours after your dose. You likely...
  • How long does it take for flavoxate to start working?
📖 Read our full Flavoxate 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.

🧪 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 71E6178C9T
    A synthetic polymer that forms flexible coatings on tablets and capsules. It helps control how quickly the medicine dissolves and protects the contents from moisture and air.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 196OC77688
    A synthetic plastic polymer used as a film-coating material on tablets and capsules. It helps protect the medication, control how fast it dissolves, and improve appearance.
  • 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 A906T4D368
    A synthetic compound derived from nonylphenol polyethylene glycol. In medications, it acts as a surfactant and emulsifier to help mix oil and water-based ingredients and improve product stability and consistency.
  • 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 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.

11 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 DailyMedingredient 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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.398 $39.82 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.7710 $77.10 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.9602 $96.02 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Oct 2021 Aug 2022 Feb 2026 Aug 2026 $0.823 $0.398
▼ Down 40% over the last 18 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Flavoxate Hydrochloride 100 mgthis 00574-0115-01 Padagis 100 tablets $0.398 AB Availability likely
Flavoxate Hydrochloride 100 mg 42806-0058-01 Epic 100 tablets $0.398 AB Availability likely
Flavoxate Hydrochloride 100 mg 24658-0720-01 PuraCap 100 tablets $0.547 AB FDA listed +37%
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2004
On the market since
Dec 2004
📍
2026
Currently FDA-listed
22 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 00574-0115-01, 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
109
Units reimbursed last 4 qtrs
6.7K
Gross reimbursed last 4 qtrs
$5.2K
Avg / prescription
$47.56
Avg / unit
$0.7710
Latest quarter Q4 2025
19Rx
Medicaid pays / ea
$0.7710
gross reimbursed
vs
NADAC / ea
$0.3982
acquisition cost
=
Spread
+$0.3728
+94% 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
41% FFS 59% MCO
Fee-for-service · 45 Rx Managed care · 64 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 2,097 units · 17.8 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 4,292 units · 11.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 335 units · 7.4 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
7.417.8
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 Ohio 17.8 /100k
2 California 11.0 /100k
3 Kentucky 7.4 /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 Flavoxate Hydrochloride — the ingredient across all brands.

Top reported reactions

Pyrexia13
Mucosal Inflammation10
Pruritus9
Hepatic Function Abnormal8
Toxic Epidermal Necrolysis8
Pneumonia7
Aspartate Aminotransferase Increased6

Age at onset

Adult5
Elderly15

Reporter sex

101 reports
Male · 58%
Female · 42%

Serious outcomes

Hospitalization57
Life-threatening14
Death10
Disabling3
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 10 1
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
00574-0115-01 You're viewing this 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0574-0115-01) 2004-12-22 Active

📄 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 50 words

INDICATIONS AND USAGE Flavoxate HCl tablets are indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. Flavoxate HCl tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.

⏱️ Dosage and Administration 58 words

DOSAGE AND ADMINISTRATION Adults and children over 12 years of age: One or two 100 mg tablets 3 or 4 times a day. With improvement of symptoms, the dose may be reduced. This drug cannot be recommended for infants and children under 12 years of age because safety and efficacy have not been demonstrated in this age group.

Contraindications 36 words

CONTRAINDICATIONS Flavoxate HCl tablets are contraindicated in patients who have any of the following obstructive conditions: pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.

⚠️ Warnings 12 words

WARNINGS Flavoxate HCl should be given cautiously in patients with suspected glaucoma.

🤒 Adverse Reactions 74 words

ADVERSE REACTIONS The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency. Gastrointestinal: Nausea, vomiting, dry mouth. CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness.

Hematologic: Leukopenia (one case which was reversible upon discontinuation of the drug). Cardiovascular: Tachycardia and palpitation. Allergic: Urticaria and other dermatoses, eosinophilia and hyperpyrexia.

Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation. Renal: Dysuria.

🤰 Pregnancy 70 words

Pregnancy: Teratogenic Effects-Pregnancy Category B. Reproduction studies have been performed in rats and rabbits at doses up to 34 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to flavoxate HCl. There are, however, no 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.

🧒 Pediatric Use 17 words

Pediatric Use: Safety and effectiveness in children below the age of 12 years have not been established.

🆘 Overdosage 34 words

OVERDOSAGE The oral LD 50 for flavoxate HCl in rats is 4273 mg/kg. The oral LD 50 for flavoxate HCl in mice is 1837 mg/kg. It is not known whether flavoxate HCl is dialyzable.

🧬 Clinical Pharmacology 59 words

CLINICAL PHARMACOLOGY Flavoxate hydrochloride counteracts smooth muscle spasm of the urinary tract and exerts its effect directly on the muscle. In a single study of 11 normal male subjects, the time to onset of action was 55 minutes. The peak effect was observed at 112 minutes. 57% of the flavoxate HCl was excreted in the urine within 24 hours.

📦 How Supplied / Storage and Handling 66 words

HOW SUPPLIED Flavoxate HCl Tablets, 100 mg, are supplied as round, white, film-coated tablets debossed "PAD" and "0115" on one side and plain on the other side, in bottles of 100. 100 mg 100's: NDC 0574- 0115 -01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Manufactured For Padagis ® Minneapolis, MN 55427 www.padagis.com Rev 05-23 7H700 RC PH3 Code 917A00

📋 Description 118 words

DESCRIPTION Flavoxate HCl tablets contain flavoxate hydrochloride, a synthetic urinary tract spasmolytic. Chemically, flavoxate hydrochloride is 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4 H -1-benzopyran-8-carboxylate hydrochloride. The empirical formula of flavoxate hydrochloride is C 24 H 25 NO 4 •HCl.

The molecular weight is 427.94. The structural formula appears below: Flavoxate HCl is supplied in tablets for oral administration. Each round, white, film-coated Flavoxate HCl tablet is debossed "PAD" and "0115" on one side and plain on the other side and contains flavoxate hydrochloride, 100 mg.

Inactive ingredients consist of colloidal silicon dioxide, ethyl acrylate, hypromellose, lactose monohydrate, magnesium stearate, methyl methacrylate, microcrystalline cellulose, nonoxynol 100 and sodium starch glycolate. Film coating is composed of hypromellose 2910 6cP and polyethylene glycol. Chemical Structure

💬 Information for Patients 31 words

Information for Patients: Patients should be informed that if drowsiness and blurred vision occur, they should not operate a motor vehicle or machinery or participate in activities where alertness is required.

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