Desonide
Alembic Pharmaceuticals, Inc.
Human Prescription Drug
NDC 62332-485Desonide is a human prescription drug labeled by 'Alembic Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Desonide is 62332-485. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Desonide drug includes Desonide - .5 mg/g . The currest status of Desonide drug is Active.
Drug Information:
| Drug NDC: | 62332-485 |
| 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: | Desonide |
| 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: | Desonide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Alembic 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: | DESONIDE - .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: | 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: | 24 Oct, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Jun, 2026 |
| 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: | ANDA212473 |
| 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: | Alembic Pharmaceuticals, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 204135
|
| 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: | 0362332485154
|
| 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: | J280872D1O
|
| 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 |
|---|
| 62332-485-15 | 1 TUBE in 1 CARTON (62332-485-15) / 15 g in 1 TUBE | 24 Oct, 2019 | N/A | No |
| 62332-485-60 | 1 TUBE in 1 CARTON (62332-485-60) / 60 g in 1 TUBE | 24 Oct, 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:
Desonide desonide desonide desonide petrolatum
Indications and Usage:
Indications and usage desonide ointment, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. it should not be used for longer than two weeks unless directed by a physician.
Dosage and Administration:
Dosage and administration desonide ointment, 0.05% should be applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. as with other corticosteroids, therapy should be discontinued when control is achieved. if no improvement is seen within two weeks, reassessment of diagnosis may be necessary. desonide ointment, 0.05% should not be used with occlusive dressings.
Contraindications:
Contraindications desonide ointment, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Adverse Reactions:
Adverse reactions in controlled clinical trials, the total incidence of adverse reactions associated with the use of desonide ointment, 0.05% was approximately 6%. these adverse reactions were erythema, induration, pruritus, irritation, oiliness, and peripheral edema. the following additional local adverse reactions have been reported infrequently with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. these reactions are listed in approximate decreasing order of occurrence: dryness, folliculitis, acneiform eruptions, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria, burning and hypopigmentation. to report suspected adverse reactions, contact alembic pharmaceuticals, inc. at 1-866-210-9797 or fda at 1-800-fda-1088 or www.fda.gov/medwatch .
Overdosage:
Overdosage topically applied desonide ointment, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see precautions ).
Description:
Description desonide ointment, 0.05% contains desonide (pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11β,16α)) a synthetic corticosteroid for topical dermatologic use. the corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. chemically, desonide, the active ingredient in desonide ointment, 0.05% is c 24 h 32 o 6 . it has the following structural formula: the molecular weight of desonide is 416.51. it is white to off-white powder. the solubility of desonide in distilled water saturated with the ether is 184 mg/l. each gram of desonide ointment, 0.05% contains 0.5 mg of desonide microdispersed in a base of white petrolatum. structure
Clinical Pharmacology:
Clinical pharmacology like other topical corticosteroids, desonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. the mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. however, corticosteroids are thought to act by the induction of phospholipase a 2 inhibitory proteins, collectively called, lipocortins. it is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. arachidonic acid is released from membrane phospholipids by phospholipase a 2 . pharmacokinetics - the extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours
Read more... markedly enhances penetration. topical corticosteroids can be absorbed from normal intact skin. inflammation and/or other disease processes in the skin may increase percutaneous absorption. studies performed with desonide ointment, 0.05% indicate that it is in the low range of potency as compared with other topical corticosteroids.
How Supplied:
How supplied desonide ointment, 0.05% is available as follows: 15 g tube (ndc 62332-485-15) 60 g tube (ndc 62332-485-60)
Package Label Principal Display Panel:
Principal display panel tube rx only ndc 62332-485-15 desonide ointment, 0.05% for external use only not for ophthalmic use net wt 15 grams tube image
Principal display panel carton rx only ndc 62332-485-15 desonide ointment, 0.05% for external use only not for ophthalmic use net wt 15 grams carton image