Ketoconazole

Tolmar Inc.
Human Prescription Drug
NDC 63646-010

Ketoconazole is a human prescription drug labeled by 'Tolmar Inc.'. National Drug Code (NDC) number for Ketoconazole is 63646-010. This drug is available in dosage form of Shampoo, Suspension. The names of the active, medicinal ingredients in Ketoconazole drug includes Ketoconazole - 20 mg/mL . The currest status of Ketoconazole drug is Active.

Drug Information:

Drug NDC:	63646-010
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:	Tolmar Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Shampoo, Suspension
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/mL
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:	11 Apr, 2005
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:	ANDA076942
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, 2024
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:	TOLMAR Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
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
63646-010-04	120 mL in 1 BOTTLE, PLASTIC (63646-010-04)	11 Apr, 2005	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 sodium laureth sulfate disodium laureth sulfosuccinate hydrochloric acid imidurea sodium chloride sodium hydroxide coco diethanolamide peg-120 methyl glucose dioleate water fd&c red no. 40 orange

Indications and Usage:

Indications and usage ketoconazole shampoo, 2%, is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by pityrosporum orbiculare (also known as malassezia furfur or m. orbiculare ). note: tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. treatment of the infection may not immediately result in normalization of pigment to the affected sites. normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. although tinea versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.

Dosage and Administration:

Dosage and administration apply the shampoo to the damp skin of the affected area and a wide margin surrounding this area. lather, leave in place for 5 minutes, and then rinse off with water. one application of the shampoo should be sufficient.

Contraindications:

Contraindications ketoconazole shampoo, 2%, is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.

Adverse Reactions:

Adverse reactions clinical trials experience in 11 double-blind trials in 264 patients using ketoconazole shampoo, 2%, for the treatment of dandruff or seborrheic dermatitis, an increase in normal hair loss and irritation occurred in less than 1% of patients. in three open-label safety trials in which 41 patients shampooed 4-10 times weekly for six months, the following adverse experiences each occurred once: abnormal hair texture, scalp pustules, mild dryness of the skin, and itching. as with other shampoos, oiliness and dryness of hair and scalp have been reported. in a double-blind, placebo-controlled trial in which patients with tinea versicolor were treated with either a single application of ketoconazole shampoo, 2%, (n=106), a daily application for three consecutive days (n=107), or placebo (n=105), drug-related adverse events occurred in 5 (5%), 7 (7%) and 4 (4%) of patients, respectively. the only events that occurred in more than one patient in any one of the three treatment Read more...

groups were pruritus, application site reaction, and dry skin; none of these events occurred in more than 3% of the patients in any one of the three groups. post-marketing experience because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency. the following adverse drug reactions have been identified during post-marketing experience with ketoconazole shampoo, 2%: there have been reports of hair discoloration and abnormal hair texture, itching, skin burning sensation, contact dermatitis, hypersensitivity, angioedema, alopecia, rash, urticaria, skin irritation, dry skin, and application site reactions.

Use in Pregnancy:

Pregnancy: teratogenic effects: pregnancy category c: 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. in humans, ketoconazole is not detected in plasma after chronic shampooing on the scalp. ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day (a dose 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.

Pediatric Use:

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

Overdosage:

Overdosage ketoconazole shampoo, 2%, is intended for external use only. in the event of accidental ingestion, supportive and symptomatic measures should be employed. induced emesis and gastric lavage should not be performed to avoid aspiration.

Description:

Description ketoconazole shampoo, 2%, is a red-orange liquid for topical application, containing the broad spectrum synthetic antifungal agent ketoconazole in a concentration of 2% in an aqueous suspension. it also contains: sodium laureth sulfate, disodium laureth sulfosuccinate, cocamide diethanolamide, hydrochloric acid, peg-120 methyl glucose dioleate, imidurea, sodium chloride, sodium hydroxide, fragrance, fd&c red no. 40, and purified water. 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: chemical structure

Clinical Pharmacology:

Clinical pharmacology tinea (pityriasis) versicolor is a non-contagious infection of the skin caused by pityrosporum orbiculare (malassezia furfur) . this commensal organism is part of the normal skin flora. in susceptible individuals the condition is often recurrent and may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. treatment of the infection may not immediately result in restoration of pigment to the affected sites. normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental skin exposure. the rate of recurrence of infection is variable. ketoconazole was not detected in plasma in 39 patients who shampooed 4-10 times per week for 6 months, or in 33 patients who shampooed 2-3 times per week for 3-26 months (mean: 16 months). an exaggerated use washing test on the sensitive antecubital skin of 10 subjects twice daily for five consecutive Read more...

days showed that the irritancy potential of ketoconazole shampoo, 2%, was significantly less than that of 2.5% selenium sulfide shampoo. a human sensitization test, a phototoxicity study, and a photoallergy study conducted in 38 male and 22 female volunteers showed no contact sensitization of the delayed hypersensitivity type, no phototoxicity and no photoallergenic potential due to ketoconazole shampoo, 2%. mode of action: interpretations of in vivo studies suggest that ketoconazole impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes. it is postulated, but not proven, that the therapeutic effect of ketoconazole in tinea (pityriasis) versicolor is due to the reduction of pityrosporum orbiculare (malassezia furfur) and that the therapeutic effect in dandruff is due to the reduction of pityrosporum ovale . support for the therapeutic effect in tinea versicolor comes from a three-arm, parallel, double-blind, placebo controlled study in patients who had moderately severe tinea (pityriasis) versicolor. successful response rates in the primary efficacy population for each of both three-day and single-day regimens of ketoconazole shampoo, 2%, were statistically significantly greater (73% and 69%, respectively) than a placebo regimen (5%). there had been mycological confirmation of fungal disease in all cases at baseline. mycological clearing rates were 84% and 78%, respectively, for the three-day and one-day regimens of the 2% shampoo and 11% in the placebo regimen. while the differences in the rates of successful response between either of the two active treatments and placebo were statistically significant, the difference between the two active regimens was not. microbiology: ketoconazole is a broad spectrum synthetic antifungal agent which inhibits the growth of the following common dermatophytes and yeasts by altering the permeability of the cell membrane: dermatophytes: trichophyton rubrum, t. mentagrophytes, t. tonsurans, microsporum canis, m. audouini, m. gypseum and epidermophyton floccosum; yeasts: candida albicans, c. tropicalis, pityrosporum ovale (malassezia ovale) and pityrosporum orbiculare (m. furfur) . development of resistance by these microorganisms to ketoconazole has not been reported.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility: long-term studies to assess the carcinogenic potential of ketoconazole shampoo, 2% have not been conducted. a long-term feeding study of ketoconazole 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 were not genotoxic. the ames salmonella microsomal activator assay was also negative.

How Supplied:

How supplied ketoconazole shampoo, 2%, is a red-orange liquid supplied in a 4-fluid ounce nonbreakable plastic bottle (ndc 63646-010-04). storage conditions: store at 20Âºc to 25Âºc (68Âºf to 77Âºf) [see usp controlled room temperature]. protect from light. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088. manufactured for: tolmar, inc. fort collins, co 80526 04006031 rev. 2 11/22

Information for Patients:

Information for patients: patients should be advised of the following: ketoconazole shampoo, 2% may be irritating to mucous membranes of the eyes and contact with this area should be avoided. the following have been reported with the use of ketoconazole shampoo, 2%: hair discoloration and abnormal hair texture, removal of the curl from permanently waved hair, itching, skin burning sensation and contact dermatitis, hypersensitivity, angioedema, alopecia, rash, urticaria, skin irritation, dry skin, and application site reactions. patients who develop allergic reactions, such as generalized rash, skin reactions, severe swelling, angioedema, or shortness of breath should discontinue ketoconazole shampoo, 2% and contact their physician immediately.

Package Label Principal Display Panel:

Principal display panel tolmar-front back

Comments/ Reviews:

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