Desoximetasone
Lupin Pharmaceuticals, Inc.
Human Prescription Drug
NDC 68180-950Desoximetasone is a human prescription drug labeled by 'Lupin Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Desoximetasone is 68180-950. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Desoximetasone drug includes Desoximetasone - 2.5 mg/g . The currest status of Desoximetasone drug is Active.
Drug Information:
| Drug NDC: | 68180-950 |
| 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: | Desoximetasone |
| 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: | Desoximetasone |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Lupin Pharmaceuticals, Inc. |
| 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: | DESOXIMETASONE - 2.5 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: | 20 Jun, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 02 Jan, 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: | ANDA208164 |
| 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: | Lupin Pharmaceuticals, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 197574
|
| 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: | 4E07GXB7AU
|
| 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 |
|---|
| 68180-950-01 | 1 TUBE in 1 CARTON (68180-950-01) / 15 g in 1 TUBE | 20 Jun, 2017 | N/A | No |
| 68180-950-02 | 1 TUBE in 1 CARTON (68180-950-02) / 60 g in 1 TUBE | 20 Jun, 2017 | N/A | No |
| 68180-950-04 | 1 TUBE in 1 CARTON (68180-950-04) / 100 g in 1 TUBE | 20 Jun, 2017 | 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:
Desoximetasone desoximetasone desoximetasone desoximetasone cetostearyl alcohol isopropyl myristate lanolin alcohols mineral oil water petrolatum white to off white
Indications and Usage:
Indications and usage desoximetasone cream usp, 0.25 % is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Warnings:
Warnings keep out of reach of children.
Dosage and Administration:
Dosage and administration apply a thin film of desoximetasone cream usp, 0.25% to the affected skin areas twice daily. rub in gently.
Contraindications:
Contraindications desoximetasone cream 0.25% is 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. in controlled clinical studies the incidence of adverse reactions were low (0.8%) for desoximetasone cream 0.25% and included burning, folliculitis, and folliculo-pustular lesions.
Use in Pregnancy:
Pregnancy teratogenic effects pregnancy category c: corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. desoximetasone has been shown to be teratogenic and embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration in doses 3 to 30 times the human dose of desoximetasone cream 0.25%. there are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. therefore, desoximetasone cream 0.25%, 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 on pregnant patients, in large amounts, or for prolonged periods of time.
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 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 desoximetasone cream usp, 0.25%, contains the active synthetic corticosteroid desoximetasone. the topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. each gram of desoximetasone cream usp, 0.25% contains 2.5 mg of desoximetasone usp in an emollient cream base consisting of cetostearyl alcohol, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. the chemical name of desoximetasone is pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11Ã,16α)-. desoximetasone has the molecular formula c 22 h 29 fo 4 and a molecular weight of 376.47. the cas registry number is 382-67-2. the structural formula is: structure
Clinical Pharmacology:
Clinical pharmacology topical corticosteroids share anti-inflammatory, antipruritic 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 be
Read more...a valuable therapeutic adjunct for treatment of resistant dermatoses. 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. pharmacokinetic studies in men with desoximetasone cream 0.25% with tagged desoximetasone showed a total of 5.2% ± 2.9% excretion in urine (4.1% ± 2.3%) and feces (1.1% ± 0.6%) and no detectable level (limit of sensitivity: 0.005 mcg/ml) in the blood when it was applied topically on the back followed by occlusion for 24 hours. seven days after application, no further radioactivity was detected in urine or feces. the half-life of the material was 15 ± 2 hours (for urine) and 17 ± 2 hours (for feces) between the third and fifth trial day. studies with other similarly structured steroids have shown that predominant metabolite reaction occurs through conjugation to form the glucuronide and sulfate ester.
How Supplied:
How supplied desoximetasone cream usp, 0.25% is supplied in: 15 gram tubes: ndc 68180-950-01 60 gram tubes: ndc 68180-950-02 100 gram tubes: ndc 68180-950-04 store at 25°c (77°f), excursions permitted to 15° to 30°c (59° to 86°f). [see usp controlled room temperature]. manufactured for: lupin pharmaceuticals, inc. baltimore, maryland 21202 united states manufactured by: lupin limited pithampur (m.p.) â 454 775 india february 2017 id#: 250901
Package Label Principal Display Panel:
Desoximetasone cream usp, 0.25% 15 g ndc 68180-950-01 rx only for topical use only. not for oral, ophthalmic, or intravaginal use. keep this and all medications out of the reach of children. tube carton