Flavoxate Hydrochloride — Tablet

Overview

Brand name

Flavoxate Hydrochloride

Generic name

Flavoxate Hydrochloride

Dosage form

Tablet

Route

Oral

Marketing category

ANDA · ANDA

Labeler

PuraCap Laboratories LLC dba Blu Pharmaceuticals

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

3

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Flavoxate Hydrochloride	100 mg/1	1095229	—

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet

Route of administration

Oral

Presentations

5

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Cholinergic Muscarinic Antagonist [EPC]	EPC	All 33 members
Cholinergic Muscarinic Antagonists [MoA]	MoA	All 33 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

076835

Application type

ANDA · Abbreviated New Drug Application

Approval date

November 30, 2005

Sponsor

EPIC PHARMA

Products on application

1

Submissions recorded

1

Products approved under application 076835.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
076835-001	FLAVOXATE HYDROCHLORIDE	TABLET		FLAVOXATE HYDROCHLORIDE	Prescription	AB

Therapeutic equivalence

Source: Orange Book

TE code

AB

Reference Listed Drug

No

Reference Standard

No

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 076835.
Type	No.	Action	Status	Date	Review
Original application	1		Approved	November 30, 2005	—

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251211). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN PRESCRIPTION DRUG · 20251211 HUMAN PRESCRIPTION DRUG · 20231227

Indications and Usage

openFDA Drug Labeling

INDICATIONS AND USAGE Flavoxate hydrochloride 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 hydrochloride tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.

Dosage and Administration

openFDA Drug Labeling

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

openFDA Drug Labeling

CONTRAINDICATIONS Flavoxate hydrochloride is 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

openFDA Drug Labeling

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

Adverse Reactions

openFDA Drug Labeling

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.

Description

openFDA Drug Labeling

DESCRIPTION Flavoxate hydrochloride 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. Each tablet for oral administration contains 100 mg flavoxate hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, polydextrose, polyethylene glycol, titanium dioxide and triacetin. Structure Formula

Overdosage

openFDA Drug Labeling

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

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Flavoxate hydrochloride 100 mg tablets are available as white, round biconvex, film-coated tablets, debossed “ Є58 ” on one side and plain on the other side. They are supplied as follows: NDC 24658-720-01 in bottles of 100 Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container. Distributed by: PuraCap Laboratories, LLC DBA Blu Pharmaceuticals Greenvale, NY 11548 Rev. 02-2025-00 MF058REV02/25 OE2582

Adverse event reports

Source: openFDA FAERS

101

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: FLAVOXATE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
42806-058-01	42806-058	Epic Pharma, LLC	100 TABLET in 1 BOTTLE (42806-058-01)	February 21, 2011
42806-058-10	42806-058	Epic Pharma, LLC	1000 TABLET in 1 BOTTLE (42806-058-10)	February 21, 2011
24658-720-01	24658-720	PuraCap Laboratories LLC dba Blu Pharmaceuticals	100 TABLET in 1 BOTTLE (24658-720-01)	December 15, 2016
42806-058	42806-058	Epic Pharma, LLC	—	February 21, 2011
24658-720	24658-720	PuraCap Laboratories LLC dba Blu Pharmaceuticals	—	December 15, 2016

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Orange Book	FDA	Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.