Cordran

Flurandrenolide

Almirall, Llc
Human Prescription Drug
NDC 16110-035

Cordran also known as Flurandrenolide is a human prescription drug labeled by 'Almirall, Llc'. National Drug Code (NDC) number for Cordran is 16110-035. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Cordran drug includes Flurandrenolide - .5 mg/g . The currest status of Cordran drug is Active.

Drug Information:

Drug NDC:	16110-035
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:	Cordran
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:	Flurandrenolide
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Almirall, Llc
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:	FLURANDRENOLIDE - .5 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:	NDA
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 Oct, 1965
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	25 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:	NDA012806
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:	Almirall, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	197716 197718 197720 205612 898418 898420
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:	0316110035123 0316110026602 0316110034126
UPC stands for Universal Product Code.
NUI:	N0000175576 N0000175450
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	8EUL29XUQT
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:	Corticosteroid Hormone Receptor Agonists [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:	Corticosteroid [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:	Corticosteroid Hormone Receptor Agonists [MoA] Corticosteroid [EPC]
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
16110-035-12	1 TUBE in 1 CARTON (16110-035-12) / 120 g in 1 TUBE	18 Oct, 1965	N/A	No
16110-035-60	1 TUBE in 1 CARTON (16110-035-60) / 60 g in 1 TUBE	18 Oct, 1965	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

Flurandrenolide

Cream
Taro Pharmaceuticals U.S.A., Inc.
NDC: 51672-5301

Cordran

Flurandrenolide

Cream
Almirall, LLC
NDC: 16110-035

Cordran

Flurandrenolide

Lotion
Almirall, LLC
NDC: 16110-052

Flurandrenolide

Lotion
Padagis Israel Pharmaceuticals Ltd
NDC: 45802-928

Cordran

Flurandrenolide

Tape
Almirall, LLC
NDC: 16110-587

Flurandrenolide

Lotion
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NDC: 63629-8657

Product Elements:

Cordran flurandrenolide flurandrenolide flurandrenolide cetyl alcohol citric acid monohydrate mineral oil polyoxyl 40 stearate propylene glycol sodium citrate stearic acid water cordran flurandrenolide flurandrenolide flurandrenolide cetyl alcohol citric acid monohydrate mineral oil polyoxyl 40 stearate propylene glycol sodium citrate stearic acid water cordran flurandrenolide flurandrenolide flurandrenolide white wax cetyl alcohol sorbitan sesquioleate petrolatum

Indications and Usage:

Indications and usage cordran Â® (flurandrenolide, usp) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

General Precautions:

General âsystemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (hpa) axis suppression, manifestations of cushing's syndrome, hyperglycemia, and glucosuria in some patients. conditions that augment systemic absorption include application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of hpa axis suppression using urinary-free cortisol and acth stimulation tests. if hpa axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. recovery of hpa axis function is generally prompt and complete upon discontinuation of the drug. infrequently, signs and symptoms of steroid withdrawal may occur, so that su Read more...

pplemental systemic corticosteroids are required. pediatric patients may absorb proportionately larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see pediatric use under precautions ). if irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. in the presence of dermatologic infections, the use of an appropriate antifungal or antibacterial agent should be instituted. if a favorable response does not occur promptly, cordran should be discontinued until the infection has been adequately controlled.

Dosage and Administration:

Dosage and administration for moist lesions, a small quantity of the cream should be rubbed gently into the affected areas 2 or 3 times a day. for dry, scaly lesions, the ointment is applied as a thin film to affected areas 2 or 3 times daily. therapy should be discontinued when control is achieved. if no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. cordran Â® (flurandrenolide, usp) should not be used with occlusive dressings unless directed by a physician. tight-fitting diapers or plastic pants may constitute occlusive dressings.

Contraindications:

Contraindications topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of these preparations.

Adverse Reactions:

Adverse reactions the following local adverse reactions are reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings. these reactions are listed in an approximate decreasing order of occurrence: burning itching irritation dryness folliculitis hypertrichosis acneform eruptions hypopigmentation perioral dermatitis allergic contact dermatitis the following may occur more frequently with occlusive dressings: maceration of the skin secondary infection skin atrophy striae miliaria postmarketing adverse reactions the following adverse reactions have been identified during post approval use of flurandrenolide, usp. because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. skin : skin striae, hypersensitivity, skin atrophy, contact dermatitis and skin discoloration.

Use in Pregnancy:

Usage in pregnancy â pregnancy category câ corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. the more potent corti-costeroids have been shown to be teratogenic after dermal application in laboratory animals. there are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. drugs of this class should not be used extensively for pregnant patients or in large amounts or for prolonged periods of time.

Pediatric Use:

Pediatric use âpediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hpa axis suppression and cushing's syndrome than do mature patients because of a larger skin surface area to body weight ratio. hypothalamic-pituitary-adrenal (hpa) axis suppression, cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

Overdosage:

Overdosage topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see precautions ).

Description:

Description cordran Â® (flurandrenolide, usp) is a potent corticosteroid intended for topical use. flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. flurandrenolide is practically insoluble in water and in ether. one gram of flurandrenolide dissolves in 72 ml of alcohol and in 10 ml of chloroform. the molecular weight of flurandrenolide is 436.52. the chemical name of flurandrenolide is pregn-4-ene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-, (6Î±, 11Î², 16Î±)-; its empirical formula is c 24 h 33 fo 6 . the structure is as follows: each gram of cordran Â® cream (flurandrenolide cream, usp) contains 0.5 mg (1.145 Âµmol; 0.05%) or 0.25 mg (0.57 Âµmol; 0.025%) flurandrenolide in an emulsified base composed of cetyl alcohol, citric acid, mineral oil, polyoxyl 40 stearate, propylene glycol, sodium citrate, stearic acid, and purified water. each gram of cordran Â® ointment (flurandrenolide ointment, usp) contains 0.5 mg (1.145 Âµmol; 0.05%) or 0.25 mg (0.57 Âµmol; 0.025%) flurandrenolide in a base composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white petrolatum. chemical structure

Clinical Pharmacology:

Clinical pharmacology cordran is primarily effective because of its anti-inflammatory, antipruritic, and vasoconstrictive actions. the mechanism of the anti-inflammatory effect of topical corticosteroids is not completely understood. corticosteroids with anti-inflammatory activity may stabilize cellular and lysosomal membranes. there is also the suggestion that the effect on the membranes of lysosomes prevents the release of proteolytic enzymes and, thus, plays a part in reducing inflammation. pharmacokinetics â the extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. topical corticosteroids can be absorbed from normal intact skin. inflammation and/or other disease processes in the skin increase percutaneous absorption. once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically ad Read more...

ministered corticosteroids. corticosteroids are bound to plasma proteins in varying degrees. they are metabolized primarily in the liver and then excreted in the kidneys. some of the topical corticosteroids and their metabolites are also excreted into the bile.

Pharmacokinetics:

Pharmacokinetics â the extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. topical corticosteroids can be absorbed from normal intact skin. inflammation and/or other disease processes in the skin increase percutaneous absorption. once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. corticosteroids are bound to plasma proteins in varying degrees. they are metabolized primarily in the liver and then excreted in the kidneys. some of the topical corticosteroids and their metabolites are also excreted into the bile.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, and impairment of fertility âlong-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

How Supplied:

How supplied cordran Â® cream is supplied in aluminum tubes as follows: cordran Â® cream, 0.025%: 120 g (ndc 16110-034-12) cordran Â® cream, 0.05%: 120 g (ndc 16110-035-12) cordran Â® ointment is supplied in aluminum tube as follows: cordran Â® ointment, 0.05%: 60 g (ndc 16110-026-60) 120 g (ndc 16110-026-12) keep out of reach of children. storage keep tightly closed. protect from light. store at 20Â° to 25Â°c (68Â° to 77Â°f) with excursions permitted to 15Â° to 30Â°c (59Â° to 86Â°f) [see usp controlled room temperature.].

Information for Patients:

Information for the patient âpatients using topical corticosteroids should receive the following information and instructions: this medication is to be used as directed by the physician. it is for external use only. avoid contact with the eyes. patients should be advised not to use this medication for any disorder other than that for which it was prescribed. the treated skin area should not be bandaged or otherwise covered or wrapped in order to be occlusive unless the patient is directed to do so by the physician. patients should report any signs of local adverse reactions, especially under occlusive dressing. parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a patient being treated in the diaper area, because these garments may constitute occlusive dressings. do not use cordran on the face, underarms, or groin areas unless directed by your physician. if no improvement is seen within 2 weeks, contact your physician. do not use ot Read more...

her corticosteroid-containing products while using cordran without first consulting your physician.

Package Label Principal Display Panel:

Principal display panel - ndc: 16110-035-12 - 0.05% cream 120 g tube label 0.05% cream 120 g tube label

Principal display panel - ndc: 16110-035-12 - 0.05% cream 120 g carton label 0.05% cream 120 g carton label

Principal display panel - ndc: 16110-034-12 - 0.025% cream 120 g tube label 0.025% cream 120 g tube label

Principal display panel - ndc: 16110-034-12 - 0.025% cream 120 g carton label 0.025% cream 120 g carton label

Principal display panel - ndc: 16110-026-60 - 0.05% ointment 60 g tube label 0.05% ointment 60 g tube label

Principal display panel - ndc: 16110-026-60 - 0.05% ointment 60 g carton label 0.05% ointment 60 g carton label

Comments/ Reviews:

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