Cordran
Flurandrenolide
Almirall, Llc
Human Prescription Drug
NDC 16110-587Cordran also known as Flurandrenolide is a human prescription drug labeled by 'Almirall, Llc'. National Drug Code (NDC) number for Cordran is 16110-587. This drug is available in dosage form of Tape. The names of the active, medicinal ingredients in Cordran drug includes Flurandrenolide - 4 ug/cm2 . The currest status of Cordran drug is Active.
Drug Information:
| Drug NDC: | 16110-587 |
| 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: | Tape |
| 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 - 4 ug/cm2
|
| 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: | 24 Sep, 2018 |
| 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: | NDA016455 |
| 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: | Almirall, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 797694
797697
|
| 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: | 0316110587806
|
| 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 |
|---|
| 16110-587-24 | 1 BOTTLE in 1 CARTON (16110-587-24) / 450 cm2 in 1 BOTTLE | 10 Sep, 2019 | N/A | No |
| 16110-587-80 | 1 BOTTLE in 1 CARTON (16110-587-80) / 1500 cm2 in 1 BOTTLE | 10 Sep, 2019 | 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:
Cordran flurandrenolide flurandrenolide flurandrenolide
Indications and Usage:
Indications and usage for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, particularly dry, scaling localized lesions.
Dosage and Administration:
Dosage and administration occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. if an infection develops, the use of cordran tape and other occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted. replacement of the tape every 12 hours produces the lowest incidence of adverse reactions, but it may be left in place for 24 hours if it is well tolerated and adheres satisfactorily. when necessary, the tape may be used at night only and removed during the day. if ends of the tape loosen prematurely, they may be trimmed off and replaced with fresh tape. the directions given below are included for the patient to follow unless otherwise instructed by the physician.
Contraindications:
Contraindications topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of these preparations. use of cordran tape is not recommended for lesions exuding serum or in intertriginous areas.
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, acneiform 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.
Overdosage:
Overdosage topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects ( see precautions ).
Description:
Description cordran tape (flurandrenolide tape, usp) is a transparent, inconspicuous, plastic surgical tape. it contains cordran (flurandrenolide, usp), a potent corticosteroid 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 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)]-, (6α, 11Ã, 16α)-; its empirical formula is c 24 h 33 fo 6 . the structural formula is as follows: each square centimeter contains 4 mcg (0.00916 μmol) flurandrenolide uniformly distributed in the adhesive layer. the tape is made of a thin, matte-finish polyethylene film that is slightly elastic and highly flexible. the adhesive is a synthetic copolymer of acrylate ester and acrylic acid that is free from substances of plant origin. the pressure-sensitive adhesive surface is covered with a protective paper liner to permit handling and trimming before application. 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. various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. there is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. 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. the tape serves as both a vehicle and an occlusive dressing. retention of insensible perspiration by the tape results in hydration of the stratum corneum and improved diffusion of the medication. the
Read more...skin is protected from scratching, rubbing, desiccation, and chemical irritation. the tape acts as a mechanical splint to fissured skin. since it prevents removal of the medication by washing or the rubbing action of clothing, the tape formulation provides a sustained action. pharmacokinetics âthe 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. occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses ( see dosage and administration ). once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to those of 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.
How Supplied:
How supplied tape: 4 mcg/sq cmâsmall roll, 24 in x 3 in (60 cm x 7.5 cm), in a flip-top vial ndc 16110-587-24 4 mcg/sq cmâlarge roll, 80 in x 3 in (200 cm x 7.5 cm), in a flip-top vial ndc 16110-587-80 store at 20-25°c (68-77°f). [see usp controlled room temperature.] keep out of reach of children. rx only
Package Label Principal Display Panel:
Principal display panel - ndc: 16110-587-80 - carton label carton label
Principal display panel - ndc: 16110-587-80 - vial label vial label