Fluocinolone Acetonide
Cosette Pharmaceuticals, Inc.
Human Prescription Drug
NDC 0713-0224Fluocinolone Acetonide is a human prescription drug labeled by 'Cosette Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Fluocinolone Acetonide is 0713-0224. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Fluocinolone Acetonide drug includes Fluocinolone Acetonide - .25 mg/g . The currest status of Fluocinolone Acetonide drug is Active.
Drug Information:
| Drug NDC: | 0713-0224 |
| 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: | Fluocinolone Acetonide |
| 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: | Fluocinolone Acetonide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cosette Pharmaceuticals, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Ointment |
| 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: | FLUOCINOLONE ACETONIDE - .25 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: | 26 Jul, 1988 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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: | ANDA089524 |
| 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: | Cosette Pharmaceuticals, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1191256
1191302
1191315
|
| 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. |
| NUI: | N0000175576
N0000175450
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 0CD5FD6S2M
|
| 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 |
|---|
| 0713-0224-15 | 1 TUBE in 1 CARTON (0713-0224-15) / 15 g in 1 TUBE | 26 Jul, 1988 | N/A | No |
| 0713-0224-60 | 1 TUBE in 1 CARTON (0713-0224-60) / 60 g in 1 TUBE | 26 Jul, 1988 | 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:
Fluocinolone acetonide fluocinolone acetonide mineral oil lanolin alcohols isopropyl palmitate propylene glycol stearate cetyl alcohol sorbitan monostearate polysorbate 60 sorbic acid polyoxyl 40 stearate water propylene glycol propylparaben methylparaben fluocinolone acetonide fluocinolone acetonide fluocinolone acetonide fluocinolone acetonide mineral oil lanolin alcohols isopropyl palmitate propylene glycol stearate cetyl alcohol sorbitan monostearate polysorbate 60 sorbic acid polyoxyl 40 stearate water propylene glycol propylparaben methylparaben fluocinolone acetonide fluocinolone acetonide fluocinolone acetonide fluocinolone acetonide light mineral oil petrolatum fluocinolone acetonide fluocinolone acetonide
Indications and Usage:
Indications and usage topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage and Administration:
Dosage and administration topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. in hairy sites, the hair should be parted to allow direct contact with the lesion. occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. some plastic films may be flammable and due care should be exercised in their use. similarly, caution should be employed when such films are used on children or left in their proximity, to avoid the possibility of accidental suffocation. 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, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria. to report suspected adverse reactions, contact cosette pharmaceuticals, inc. at 1-800-922-1038 or fda at 1-800-fda-1088 or www.fda.gov/medwatch .
Overdosage:
Overdosage topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see precautions ).
Description:
Description the topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. fluocinolone acetonide is included in this class of synthetic corticosteroids. chemically fluocinolone acetonide is pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α, 11β, 6α)-), with the molecular formula c 24 h 30 f 2 0 6 , a molecular weight of 452.49 and the following structural formula: each gram of fluocinolone acetonide cream usp 0.01% contains 0.1 mg fluocinolone acetonide usp and each gram of fluocinolone acetonide cream usp 0.025% contains: 0.25 mg fluocinolone acetonide in a water washable cream base consisting of mineral oil (and) lanolin alcohols, isopropyl palmitate nf, propylene glycol stearate, cetyl alcohol nf, sorbitan monostearate nf, polysorbate 60 nf, sorbic acid nf, polyoxyl (40) stearate nf, purified water usp, propylene glycol usp with propylparaben nf and methylparaben nf as preservatives. each gram of fluocinolone acetonide ointment usp 0.025% contains 0.25 mg of fluocinolone acetonide usp in an ointment base consisting of light mineral oil nf and white petrolatum usp. chemical structure
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. 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
Read more...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 in the bile.
How Supplied:
How supplied fluocinolone acetonide cream 0.01% usp is supplied in: 15 g tubes ndc 0713-0223-15, 60 g tubes ndc 0713-0223-60 fluocinolone acetonide cream 0.025% usp is supplied in: 15 g tubes ndc 0713-0222-15, 60 g tubes ndc 0713-0222-60 fluocinolone acetonide ointment 0.025% usp is supplied in: 15 g tubes ndc 0713-0224-15, 60 g tubes ndc 0713-0224-60 rx only store at controlled room temperature 15°-30° c (59°-86° f). distributed by: cosette pharmaceuticals, inc. south plainfield, nj 07080 vc7669 rev. 09/2022 8-fluocplnc3
Package Label Principal Display Panel:
Ndc 0713-0222-15 fluocinolone acetonide cream usp 0.025% 15 g for external use only not for ophthalmic use rx only g&w laboratories, inc. ndc 0713-0222-60 fluocinolone acetonide cream usp 0.025% 60 g for external use only not for ophthalmic use rx only g&w laboratories, inc. carton-15g.jpg tube-15g.jpg carton-60g.jpg tube-60g.jpg
Principal display panel ndc 0713-0223-15 fluocinolone acetonide cream usp 0.01% 15 g for external use only. not for ophthalmic use. rx only cosette pharmaceuticals, inc. ndc 0713-0223-60 fluocinolone acetonide cream usp 0.01% 60 g for external use only. not for ophthalmic use. rx only cosette pharmaceuticals, inc. carton-15-223 tube-15-223 carton-60-223 tube-60-223
Principal display panel ndc 0713-0224-15 fluocinolone acetonide ointment, usp 0.025% 15 g for external use only. not for ophthalmic use. rx only cosette pharmaceuticals, inc. ndc 0713-0224-60 fluocinolone acetonide ointment, usp 0.025% 60 g for external use only. not for ophthalmic use. rx only cosette pharmaceuticals, inc. 224-carton-15g 224-tube-15g 224-carton-60g 224-tube-60g