Flavoxate Hydrochloride
Padagis Us Llc
Human Prescription Drug
NDC 0574-0115Flavoxate Hydrochloride is a human prescription drug labeled by 'Padagis Us Llc'. National Drug Code (NDC) number for Flavoxate Hydrochloride is 0574-0115. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Flavoxate Hydrochloride drug includes Flavoxate Hydrochloride - 100 mg/1 . The currest status of Flavoxate Hydrochloride drug is Active.
Drug Information:
| Drug NDC: | 0574-0115 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Flavoxate Hydrochloride |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Flavoxate Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Padagis Us Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Film Coated |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | FLAVOXATE HYDROCHLORIDE - 100 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 22 Dec, 2004 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA076831 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Padagis US LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1095229
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0305740115015
|
| UPC stands for Universal Product Code. |
| UNII: | 9C05J6089W
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Cholinergic Muscarinic Antagonist [EPC]
Cholinergic Muscarinic Antagonists [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0574-0115-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0574-0115-01) | 22 Dec, 2004 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Flavoxate hydrochloride flavoxate hydrochloride flavoxate hydrochloride flavoxate silicon dioxide ethyl acrylate hypromellose, unspecified lactose monohydrate magnesium stearate methyl methacrylate microcrystalline cellulose nonoxynol-100 sodium starch glycolate type a potato hypromellose 2910 (6 mpa.s) polyethylene glycol, unspecified pad;0115
Indications and Usage:
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.
Warnings:
Warnings flavoxate hcl should be given cautiously in patients with suspected glaucoma.
Dosage and Administration:
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:
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.
Adverse Reactions:
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.
Use in Pregnancy:
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:
Pediatric use: safety and effectiveness in children below the age of 12 years have not been established.
Overdosage:
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.
Description:
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 â¢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
Clinical Pharmacology:
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.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility: mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of flavoxate hcl have not been performed.
How Supplied:
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]
Information for Patients:
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.
Package Label Principal Display Panel:
Principal display panel - 100 mg tablet bottle rx only ndc 0574- 0115 -01 flavoxate hcl tablets 100 mg 100 tablets the following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. 7h7-rc-flavoxate-hcl-tablets.jpg serialization-template.jpg