Fluocinonide
Zydus Pharmaceuticals Usa Inc.
Human Prescription Drug
NDC 70710-1284Fluocinonide is a human prescription drug labeled by 'Zydus Pharmaceuticals Usa Inc.'. National Drug Code (NDC) number for Fluocinonide is 70710-1284. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Fluocinonide drug includes Fluocinonide - .5 mg/mL . The currest status of Fluocinonide drug is Active.
Drug Information:
| Drug NDC: | 70710-1284 |
| 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: | Fluocinonide |
| 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: | Fluocinonide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Zydus Pharmaceuticals Usa Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| 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: | FLUOCINONIDE - .5 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: | 01 Nov, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 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: | ANDA208948 |
| 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: | Zydus Pharmaceuticals USA Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 310364
|
| 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: | 0370710128432
|
| 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: | 2W4A77YPAN
|
| 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 |
|---|
| 70710-1284-3 | 60 mL in 1 BOTTLE (70710-1284-3) | 01 Nov, 2018 | N/A | No |
| 70710-1284-8 | 20 mL in 1 BOTTLE (70710-1284-8) | 01 Nov, 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:
Fluocinonide fluocinonide fluocinonide fluocinonide alcohol citric acid monohydrate diisopropyl adipate propylene glycol water
Indications and Usage:
Indications and usage fluocinonide topical solution usp, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage and Administration:
Dosage and administration fluocinonide topical solution usp, 0.05% is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. if an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Contraindications:
Contraindications topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
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 hypertrichosis maceration of the skin itching acneiform eruptions secondary infection irritation hypopigmentation skin atrophy dryness perioral dermatitis striae folliculitis allergic contact dermatitis miliaria
Adverse Reactions Table:
| Burning | Hypertrichosis | Maceration of the skin |
| Itching | Acneiform eruptions | Secondary infection |
| Irritation | Hypopigmentation | Skin atrophy |
| Dryness | Perioral dermatitis | Striae |
| Folliculitis | Allergic contact dermatitis | Miliaria |
Pediatric Use:
Pediatric use pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hpa axis suppression and cushing's syndrome than 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 children receiving topical corticosteroids. manifestations of adrenal suppression in children 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 children should be limited to the least amount compatible with an effective therapeutic regimen. chronic corticosteroid therapy may interfere with the growth and development of children.
Overdosage:
Overdosage topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (see precautions .)
Description:
Description fluocinonide topical solution usp, 0.05% is intended for topical administration. the active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4 -diene-3,20 -dione,21-(acetyloxy)-6 ,9 -difluoro -11-hydro xy-16 ,17-[(1- methylethylidene)bis(oxy)]-,(6 α, 11β, 16 α)-. it has the following chemical structure: fluocinonide, usp is white or almost white microcrystalline powder. it is practically insoluble in water, very slightly soluble in ether, slightly soluble in ethanol, methanol and dioxane, sparingly soluble in acetone and chloroform. fluocinonide topical solution usp, 0.05% contains fluocinonide usp, 0.5 mg/ml in a solution of citric acid monohydrate, dehydrated alcohol (35%), diisopropyl adipate, propylene glycol and purified water. in this formulation, the active ingredient is totally in solution. fluocinonide topical solution usp, 0.5%
Clinical Pharmacology:
Clinical pharmacology topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. the mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. 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. pharmacokinetics 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. a significantly greater amount of fluocinonide is absorbed from the solution than from the cream or gel formulations. topical corticosteroids can be absorbed from normal intact skin. inflammation and/or other disease processes in the skin increase percutaneous absorption. occlusive dre
Read more...ssings 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 systemically administered corticosteroids. corticosteroids are bound to plasma proteins in varying degrees. corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. some of the topical corticosteroids and their metabolites are also excreted into the bile.
Pharmacokinetics:
Pharmacokinetics 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. a significantly greater amount of fluocinonide is absorbed from the solution than from the cream or gel formulations. 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 systemically administered corticosteroids. corticosteroids are bound to plasma proteins in varying degrees. corticosteroids are metabolized primarily in the liver and a
Read more...re then excreted by the kidneys. some of the topical corticosteroids and their metabolites are also excreted into the bile.
How Supplied:
How supplied fluocinonide topical solution usp, 0.05% is clear solution free from particulate matter and is supplied as: ndc 70710-1284-8 in bottle of 20 ml ndc 70710-1284-3 in bottle of 60 ml store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. avoid excessive heat, above 40°c (104°f). call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088. please address medical inquiries to, (medicalaffairs@zydususa.com) tel.: 1-877-993-8779.
Package Label Principal Display Panel:
Package label.principal display panel ndc 70710-1284-3 fluocinonide topical solution usp, 0.05% rx only 60 ml zydus fluocinonide topical solution usp, 0.5% image fluocinonide topical solution usp, 0.05%