Econazole Nitrate

Bryant Ranch Prepack
Human Prescription Drug
NDC 63629-8645

Econazole Nitrate is a human prescription drug labeled by 'Bryant Ranch Prepack'. National Drug Code (NDC) number for Econazole Nitrate is 63629-8645. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Econazole Nitrate drug includes Econazole Nitrate - 10 mg/g . The currest status of Econazole Nitrate drug is Active.

Drug Information:

Drug NDC:	63629-8645
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:	Econazole Nitrate
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:	Econazole Nitrate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Bryant Ranch Prepack
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:	ECONAZOLE NITRATE - 10 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:	08 Aug, 2006
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	23 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:	ANDA076479
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:	Bryant Ranch Prepack
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	857366
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.
UNII:	H438WYN10E
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:	Azole Antifungal [EPC] Azoles [CS]
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
63629-8645-1	1 TUBE in 1 CARTON (63629-8645-1) / 15 g in 1 TUBE	21 Dec, 2006	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.

Other medicines with the same generic name

Ecoza

Zolpak

Econazole Nitrate

Kit
PureTek Corporation
NDC: 59088-752

Econazole Nitrate

Cream
Preferred Pharmaceuticals Inc.
NDC: 68788-8170

Econazole Nitrate

Cream
Taro Pharmaceuticals U.S.A., Inc.
NDC: 51672-1303

Product Elements:

Econazole nitrate econazole nitrate econazole nitrate econazole benzoic acid butylated hydroxyanisole mineral oil water peg-5 oleate pegoxol 7 stearate structural formula image

Drug Interactions:

Drug interactions warfarin concomitant administration of econazole and warfarin has resulted in enhancement of anticoagulation effect. most cases reported product application with use under occlusion, genital application, or application to large body surface area which may increase the systemic absorption of econazole nitrate. monitoring of international normalized ratio (inr) and/or prothrombin time may be indicated especially for patients who apply econazole to large body surface areas, in the genital area, or under occlusion.

Indications and Usage:

Indications and usage econazole nitrate cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by trichophyton rubrum, trichophyton mentagrophytes, trichophyton tonsurans, microsporum canis, microsporum audouini, microsporum gypseum, and epidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.

Warnings:

Warnings econazole nitrate cream 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. for external use only. avoid introduction of econazole nitrate cream into the eyes.

Dosage and Administration:

Dosage and administration sufficient econazole nitrate cream, 1% should be applied to cover affected areas once daily in patients with tinea pedis, tinea cruris, tinea corporis, and tinea versicolor, and twice daily (morning and evening) in patients with cutaneous candidiasis. early relief of symptoms is experienced by the majority of patients and 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 and tinea pedis for one month in order to reduce the possibility of recurrence. if a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined. patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

Contraindications:

Contraindications econazole nitrate cream is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.

Adverse Reactions:

Adverse reactions during clinical trials, approximately 3% of patients treated with econazole nitrate cream, 1% reported side effects thought possibly to be due to the drug, consisting mainly of burning, itching, stinging, and erythema. one case of pruritic rash has also been reported.

Drug Interactions:

Use in Pregnancy:

Pregnancy econazole nitrate has not been shown to be teratogenic when administered orally to mice, rabbits or rats. fetotoxic or embryotoxic effects were observed in segment i oral studies with rats receiving 10 to 40 times the human dermal dose. similar effects were observed in segment ii or segment iii studies with mice, rabbits and/or rats receiving oral doses 80 or 40 times the human dermal dose. econazole nitrate should be used in the first trimester of pregnancy only when the physician considers it essential to the welfare of the patient. the drug should be used during the second and third trimesters of pregnancy only if clearly needed.

Overdosage:

Overdose overdosage of econazole nitrate in humans has not been reported to date. in mice, rats, guinea pigs and dogs, the oral ld 50 values were found to be 462, 668, 272, and >160 mg/kg, respectively.

Description:

Description econazole nitrate cream contains the antifungal agent, econazole nitrate 1%, in a water-miscible base consisting of benzoic acid, butylated hydroxyanisole, mineral oil, peglicol 5 oleate, pegoxol-7 stearate, and purified water. the white to off-white soft cream is for topical use only. chemically, econazole nitrate is 1-[2-{(4-chlorophenyl)methoxy}-2-(2,4-dichlorophenyl)ethyl]-1h-imidazole mononitrate. its structure is as follows:

Clinical Pharmacology:

Clinical pharmacology after topical application to the skin of normal subjects, systemic absorption of econazole nitrate is extremely low. although most of the applied drug remains on the skin surface, drug concentrations were found in the stratum corneum which, by far, exceeded the minimum inhibitory concentration for dermatophytes . inhibitory concentrations were achieved in the epidermis and as deep as the middle region of the dermis. less than 1% of the applied dose was recovered in the urine and feces. microbiology: econazole nitrate has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the indications and usage section. dermatophytes yeasts epidermophyton floccosum trichophyton mentagrophytes candida albicans microsporum audouini trichophyton rubrum malassezia furfur microsporum canis trichophyton tonsurans microsporum gypseum econazole nitrate exhibits broad-spectrum antifungal activity against Read more...

the following organisms in vitro , but the clinical significance of these data is unknown . dermatophytes yeasts trichophyton verrucosum candida guillermondii candida parapsilosis candida tropicalis

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility long-term animal studies to determine carcinogenic potential have not been performed. oral administration of econazole nitrate in rats has been reported to produce prolonged gestation. intravaginal administration in humans has not shown prolonged gestation or other adverse reproductive effects attributable to econazole nitrate therapy.

How Supplied:

How supplied econazole nitrate cream, 1% is available as follows: 15 g tube (ndc 63629-8645-1) store at 20-25Âºc (68-77Âºf) [see usp controlled room temperature]. to report suspected adverse reactions, contact padagis at 1-866-634-9120 or fda at 1-800-fda-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions.

Package Label Principal Display Panel:

Econazole nitrate 1% cream, #15 label

Comments/ Reviews:

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