Econazole Nitrate
Preferred Pharmaceuticals Inc.
Human Prescription Drug
NDC 68788-7406Econazole Nitrate is a human prescription drug labeled by 'Preferred Pharmaceuticals Inc.'. National Drug Code (NDC) number for Econazole Nitrate is 68788-7406. 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: | 68788-7406 |
| 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: | Preferred Pharmaceuticals Inc. |
| 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: | 06 Jun, 2018 |
| 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: | ANDA076574 |
| 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: | Preferred Pharmaceuticals Inc.
|
| 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 |
|---|
| 68788-7406-1 | 15 g in 1 TUBE (68788-7406-1) | 05 Sep, 2019 | N/A | No |
| 68788-7406-3 | 1 TUBE in 1 CARTON (68788-7406-3) / 30 g in 1 TUBE | 06 Jun, 2018 | 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:
Econazole nitrate econazole nitrate econazole nitrate econazole pegoxol 7 stearate peg-5 oleate mineral oil benzoic acid butylated hydroxyanisole water
Indications and Usage:
Indications and usage econazole nitrate cream 1% 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 1% 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 1% 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 1% 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 1% cream 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.
Use in Pregnancy:
Pregnancy pregnancy category c 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. to report suspected adverse reactions , contact teligent pharma, inc. at 1-856-697-1441, or fda at 1-800-fda-1088 or www.fda.gov/medwatch .
Description:
Description econazole nitrate cream 1% contains the antifungal agent, econazole nitrate 1% in a water miscible base consisting of pegoxol 7 stearate, peglicol 5 oleate, mineral oil, benzoic acid, butylated hydroxyanisole, and purified water. the white to off-white soft cream is for topical use only. chemically, econazole nitrate is 1-[2-{(4-chloro-phenyl) methoxy}-2-(2,4-dichlorophenyl)ethyl]-1h-imidazole mononitrate. its structure is as follows: chemical structure
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 candida albicans microsporum audouini malassezia furfur microsporum canis microsporum gypseum trichophyton mentagrophytes trichophyton rubrum trichophyton tonsurans econazole nitrate exhibits broad-spectrum antifungal activity against th
Read more...e 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:
Carcinogenicity studies long-term animal studies to determine carcinogenic potential have not been performed.
Fertility (reproduction) 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 supplied in tubes of; 15 grams (ndc68788-7046-1) 30 grams (ndc68788-7046-3) store at controlled room temperature 20° - 25°c (68° - 77°f).
Package Label Principal Display Panel:
Principal display panel - 30 g tube label ndc 68788-7406-3 econazole nitrate cream 1% 30 grams rx only for topical use only not for ophthalmic use econazole nitrate cream, 1%