Ketoconazole

Proficient Rx Lp
Human Prescription Drug
NDC 63187-774

Ketoconazole is a human prescription drug labeled by 'Proficient Rx Lp'. National Drug Code (NDC) number for Ketoconazole is 63187-774. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Ketoconazole drug includes Ketoconazole - 20 mg/g . The currest status of Ketoconazole drug is Active.

Drug Information:

Drug NDC:	63187-774
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:	Ketoconazole
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:	Ketoconazole
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Proficient Rx Lp
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Cream
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:	KETOCONAZOLE - 20 mg/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
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:	18 Dec, 2002
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	17 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:	ANDA075638
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:	Proficient Rx LP
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	203088
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.
NUI:	N0000175487 M0002083 N0000182141 N0000190115 N0000185503
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	R9400W927I
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 MOA:	Cytochrome P450 3A4 Inhibitors [MoA] Cytochrome P450 3A5 Inhibitors [MoA] P-Glycoprotein Inhibitors [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:	Azole Antifungal [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class CS:	Azoles [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Azole Antifungal [EPC] Azoles [CS] Cytochrome P450 3A4 Inhibitors [MoA] Cytochrome P450 3A5 Inhibitors [MoA] P-Glycoprotein Inhibitors [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
63187-774-15	1 TUBE in 1 CARTON (63187-774-15) / 15 g in 1 TUBE	01 Nov, 2016	N/A	No
63187-774-30	1 TUBE in 1 CARTON (63187-774-30) / 30 g in 1 TUBE	01 Nov, 2016	N/A	No
63187-774-60	1 TUBE in 1 CARTON (63187-774-60) / 60 g in 1 TUBE	01 Nov, 2016	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.

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Product Elements:

Ketoconazole ketoconazole ketoconazole ketoconazole butylated hydroxyanisole cetyl alcohol isopropyl myristate polysorbate 60 polysorbate 80 propylene glycol water sorbitan monostearate stearyl alcohol white to off-white

Indications and Usage:

Indications and usage ketoconazole cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by trichophyton rubrum, t. mentagrophytes and epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by malassezia furfur (pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by candida spp. and in the treatment of seborrheic dermatitis.

Warnings:

Warnings ketoconazole cream, 2% is not for ophthalmic use.

General Precautions:

General if a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. hepatitis (1:10,000 reported incidence) and, at high doses, lowered testosterone and acth induced corticosteroid serum levels have been seen with orally administered ketoconazole; these effects have not been seen with topical ketoconazole.

Dosage and Administration:

Dosage and administration cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor it is recommended that ketoconazole cream, 2% be applied once daily to cover the affected and immediate surrounding area. clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence. patients with tinea versicolor usually require two weeks of treatment. patients with tinea pedis require six weeks of treatment. seborrheic dermatitis ketoconazole cream, 2% should be applied to the affected area twice daily for four weeks or until clinical clearing. if a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.

Contraindications:

Contraindications ketoconazole cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.

Adverse Reactions:

Adverse reactions during clinical trials 45 (5.0%) of 905 patients treated with ketoconazole cream, 2% and 5 (2.4%) of 208 patients treated with placebo reported side effects consisting mainly of severe irritation, pruritus and stinging. one of the patients treated with ketoconazole cream developed a painful allergic reaction. in worldwide postmarketing experience, rare reports of contact dermatitis have been associated with ketoconazole cream or one of its excipients, namely propylene glycol.

Use in Pregnancy:

Pregnancy teratogenic effects pregnancy category c ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day, (10 times the maximum recommended human oral dose). however, these effects may be related to maternal toxicity, which was seen at this and higher dose levels. there are no adequate and well-controlled studies in pregnant women. ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pediatric Use:

Pediatric use safety and effectiveness in children have not been established.

Description:

Description ketoconazole cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%, formulated in an aqueous cream vehicle consisting of butylated hydroxyanisole (bha), cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, purified water, sorbitan monostearate and stearyl alcohol. ketoconazole is cis -1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1 h -imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl] piperazine and has the following structural formula: molecular formula: c 26 h 28 cl 2 n 4 o 4 molecular weight: 531.43 chemical structure

Clinical Pharmacology:

Clinical pharmacology when ketoconazole cream, 2% was applied dermally to intact or abraded skin of beagle dogs for 28 consecutive days at a dose of 80 mg, there were no detectable plasma levels using an assay method having a lower detection limit of 2 ng/ml. after a single topical application to the chest, back and arms of normal volunteers, systemic absorption of ketoconazole was not detected at the 5 ng/ml level in blood over a 72-hour period. two dermal irritancy studies, a human sensitization test, a phototoxicity study and a photoallergy study conducted in 38 male and 62 female volunteers showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity and no photoallergenic potential due to ketoconazole cream, 2%. microbiology ketoconazole is a broad spectrum synthetic antifungal agent which inhibits the in vitro growth of the following common dermatophytes and yeasts by altering the permeability of the cell membrane: dermatophytes: trichophy Read more...

ton rubrum, t. mentagrophytes, t. tonsurans, microsporum canis, m. audouini, m. gypseum and epidermophyton floccosum; yeasts: candida albicans, malassezia ovale (pityrosporum ovale) and c. tropicalis; and the organism responsible for tinea versicolor, malassezia furfur (pityrosporum orbiculare). only those organisms listed in the indications and usage section have been proven to be clinically affected. development of resistance to ketoconazole has not been reported. mode of action in vitro studies suggest that ketoconazole impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes. it is postulated that the therapeutic effect of ketoconazole in seborrheic dermatitis is due to the reduction of m. ovale, but this has not been proven.

Mechanism of Action:

Mode of action in vitro studies suggest that ketoconazole impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes. it is postulated that the therapeutic effect of ketoconazole in seborrheic dermatitis is due to the reduction of m. ovale, but this has not been proven.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility a long-term feeding study in swiss albino mice and in wistar rats showed no evidence of oncogenic activity. the dominant lethal mutation test in male and female mice revealed that single oral doses of ketoconazole as high as 80 mg/kg produced no mutation in any stage of germ cell development. the ames' salmonella microsomal activator assay was also negative.

How Supplied:

How supplied ketoconazole cream, 2% is supplied in 15 g (ndc 63187-774-15), 30 g (ndc 63187-774-30), and 60 g (ndc 63187-774-60) tubes. store at 20Â°-25Â°c (68Â°-77Â°f) [see usp controlled room temperature].

Package Label Principal Display Panel:

Principal display panel - 15 g tube carton ndc 63187-774-15 15 g ketoconazole cream 2% for dermatologic use only. not for ophthalmic use. rx only keep this and all medications out of the reach of children. 63187-774-15

Comments/ Reviews:

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