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NDC 24658-0720-01 Flavoxate Hydrochloride 100 mg/1 Details

Flavoxate Hydrochloride 100 mg/1

Flavoxate Hydrochloride is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PuraCap Laboratories LLC dba Blu Pharmaceuticals. The primary component is FLAVOXATE HYDROCHLORIDE.

MedlinePlus Drug Summary

Flavoxate is used to treat overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination) relieve painful, frequent, or nighttime urination and urgency that may occur with infections of the prostate, bladder, or kidneys. Flavoxate is in a class of medications called antimuscarinics. It works by relaxing the bladder muscles. However, flavoxate is not an antibiotic; it does not cure infections.

Related Packages: 24658-0720-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Flavoxate

Product Information

NDC	24658-0720
Product ID	24658-720_a0b7130d-d064-4916-80c6-c1168a21ed0c
Associated GPIs	54400025100310
GCN Sequence Number	004927
GCN Sequence Number Description	flavoxate HCl TABLET 100 MG ORAL
HIC3	R1A
HIC3 Description	URINARY TRACT ANTISPASMODIC/ANTIINCONTINENCE AGENT
GCN	19360
HICL Sequence Number	002047
HICL Sequence Number Description	FLAVOXATE HCL
Brand/Generic	Generic
Proprietary Name	Flavoxate Hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	Flavoxate Hydrochloride
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	100
Active Ingredient Units	mg/1
Substance Name	FLAVOXATE HYDROCHLORIDE
Labeler Name	PuraCap Laboratories LLC dba Blu Pharmaceuticals
Pharmaceutical Class	Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076835
Listing Certified Through	2024-12-31

Package

Package Images

NDC 24658-0720-01 (24658072001)

Pricing Information
NDC Package Code	24658-720-01
Billing NDC	24658072001
Package	100 TABLET in 1 BOTTLE (24658-720-01)
Marketing Start Date	2016-12-15
NDC Exclude Flag	N
Price Per Unit	0.54668
Pricing Unit	EA
Effective Date	2023-08-23
NDC Description	FLAVOXATE HCL 100 MG TABLET
Pharmacy Type Indicator	C/I
OTC	N
Explanation Code	4
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL f6a06eda-2480-4c0d-8d1e-9e3e89d3ee88 Details

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 24H 25NO 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.

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 hydrochloride was excreted in the urine within 24 hours.

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.

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

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

PRECAUTIONS

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of flavoxate hydrochloride have not been performed.

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 hydrochloride. 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.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when flavoxate hydrochloride is administered to a nursing woman.

Pediatric Use

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

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.

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.

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.

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

Franklin, KY 42134 USA

1-877-264-0258

Manufactured in USA

Issued August 2016

MF058ISS08/16

OE2582

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 100 mg 100ct

Flavoxate Hydrochloride Tablets, 100 mg

Rx Only

100 Film-Coated Tablets

INGREDIENTS AND APPEARANCE

FLAVOXATE HYDROCHLORIDE

flavoxate hydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:24658-720
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FLAVOXATE HYDROCHLORIDE (UNII: 9C05J6089W) (FLAVOXATE - UNII:3E74Y80MEY)	FLAVOXATE HYDROCHLORIDE	100 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE 2910 (50 MPA.S) (UNII: 1IVH67816N)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	E58
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24658-720-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/15/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076835	12/15/2016

Labeler - PuraCap Laboratories LLC dba Blu Pharmaceuticals (080210964)

Registrant - Epic Pharma, LLC (827915443)

Name	Address	ID/FEI	Business Operations
Establishment
Epic Pharma, LLC		827915443	manufacture(24658-720)

Revised: 11/2021

Document Id: a0b7130d-d064-4916-80c6-c1168a21ed0c

Set id: f6a06eda-2480-4c0d-8d1e-9e3e89d3ee88

Version: 5

Effective Time: 20211109