Clobetasol Propionate
Bryant Ranch Prepack
Human Prescription Drug
NDC 63629-2395Clobetasol Propionate is a human prescription drug labeled by 'Bryant Ranch Prepack'. National Drug Code (NDC) number for Clobetasol Propionate is 63629-2395. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Clobetasol Propionate drug includes Clobetasol Propionate - .5 mg/g . The currest status of Clobetasol Propionate drug is Active.
Drug Information:
| Drug NDC: | 63629-2395 |
| 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: | Clobetasol Propionate |
| 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: | Clobetasol Propionate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bryant Ranch Prepack |
| 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: | CLOBETASOL PROPIONATE - .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: | 31 Jan, 2019 |
| 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: | ANDA211401 |
| 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: | Bryant Ranch Prepack
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 861495
|
| 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. |
| UNII: | 779619577M
|
| 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: | 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 |
|---|
| 63629-2395-1 | 1 TUBE in 1 CARTON (63629-2395-1) / 15 g in 1 TUBE | 03 Mar, 2021 | 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:
Clobetasol propionate clobetasol propionate clobetasol propionate clobetasol propylene glycol glyceryl monostearate cetostearyl alcohol peg-100 stearate white wax chlorocresol anhydrous trisodium citrate anhydrous citric acid water structure
Indications and Usage:
Indications & usage clobetasol propionate cream is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamicpituitary- adrenal (hpa) axis. use in pediatric patients under 12 years of age is not recommended. as with other highly active corticosteroids, therapy should be discontinued when control has been achieved. if no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
Dosage and Administration:
Dosage & administration apply a thin layer of clobetasol propionate cream to the affected skin areas twice daily and rub in gently and completely (see indications and usage ). clobetasol propionate cream is super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used. as with other highly active corticosteroids, therapy should be discontinued when control has been achieved. if no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. clobetasol propionate cream should not be used with occlusive dressings. geriatric use: in studies where geriatric patients (65 years of age or older, see precautions ) have been treated with clobetasol propionate cream, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
Contraindications:
Contraindications clobetasol propionate cream usp, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
Adverse Reactions:
Adverse reactions in controlled clinical trials, the most frequent adverse reactions reported for clobetasol propionate cream were burning and stinging sensation in 1% of treated patients. less frequent adverse reactions were itching, skin atrophy, and cracking and fissuring of the skin. cushing syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations. the following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. these reactions are listed in an approximately decreasing order of occurrence: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria. to report suspected adverse reactions, contact rising pharmaceuticals, inc. at 1-866-562-4597 or fda at 1-800-fda-1088 or www.fda.gov/medwatc
Read more...h.
Overdosage:
Overdosage topically applied clobetasol propionate cream can be absorbed in sufficient amounts to produce systemic effects (see precautions ).
Description:
Description clobetasol propionate cream usp, 0.05% contain the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. chemically, clobetasol propionate is (11Ã,16Ã)-21-chloro-9- fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4- diene-3,20-dione, and it has the following structural formula: clobetasol propionate has the molecular formula c 25 h 32 clfo 5 and a molecular weight of 467. it is a white to cream-colored crystalline powder insoluble in water. clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of propylene glycol, glyceryl monostearate, cetostearyl alcohol, glyceryl stearate/peg 100 stearate, white wax, chlorocresol, sodium citrate anhydrous, citric acid anhydrous, and purified water.
Clinical Pharmacology:
Clinical pharmacology like other topical corticosteroids, clobetasol propionate 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 dressing with hydrocortisone for up to 24 hours has not been demonstrated to increase penetration; however, occlusion of hydrocortisone for
Read more... 96 hours 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 clobetasol propionate cream indicate that they are in the super-high range of potency as compared with other topical corticosteroids.
How Supplied:
How supplied clobetasol propionate cream usp, 0.05% is supplied in 15-g tubes (ndc 63629-2395-1). store at 20° to 25°c (68° to 77°f); excursions permitted to 15° to 30°c (59° to 86°f) [see usp controlled room temperature]. clobetasol propionate cream should not be refrigerated. rx only
Package Label Principal Display Panel:
Clobetasol propionate cream, #15 label