Betamethasone Dipropionate
A-s Medication Solutions
Human Prescription Drug
NDC 50090-4679Betamethasone Dipropionate is a human prescription drug labeled by 'A-s Medication Solutions'. National Drug Code (NDC) number for Betamethasone Dipropionate is 50090-4679. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Betamethasone Dipropionate drug includes Betamethasone Dipropionate - .5 mg/g . The currest status of Betamethasone Dipropionate drug is Active.
Drug Information:
| Drug NDC: | 50090-4679 |
| 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: | Betamethasone Dipropionate |
| 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: | Betamethasone Dipropionate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | A-s Medication Solutions |
| 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: | BETAMETHASONE DIPROPIONATE - .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: | 26 Feb, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 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: | ANDA208885 |
| 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: | A-S Medication Solutions
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 238920
|
| 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: | 826Y60901U
|
| 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 |
|---|
| 50090-4679-0 | 1 TUBE in 1 CARTON (50090-4679-0) / 15 g in 1 TUBE | 04 Nov, 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:
Betamethasone dipropionate betamethasone dipropionate betamethasone dipropionate betamethasone ceteth-20 cetostearyl alcohol chlorocresol mineral oil petrolatum sodium phosphate, monobasic, unspecified form water off white
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 apply a thin film of betamethasone dipropionate cream to the affected skin areas once daily. in some cases, twice daily dosage may be necessary. if an infection develops, appropriate antimicrobial therapy should be instituted. betamethasone dipropionate products should not be used with occlusive dressings.
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 when betamethasone dipropionate products are used as recommended in the dosage and administration section. 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 infections, skin atrophy, striae and miliaria. systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (hpa) axis suppression, manifestations of cushing's syndrome, hyperglycemia and glucosuria in some patients.
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 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 children.
Overdosage:
Overdosage topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see precautions ).
Description:
Description betamethasone dipropionate cream usp, 0.05% contains betamethasone dipropionate usp, a synthetic adrenocorticosteroid, for dermatologic use. betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. betamethasone dipropionate, usp is a white to almost white crystalline powder. it is practically insoluble in water, sparingly soluble in alcohol and freely soluble in acetone, methylene chloride and chloroform. chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. the structural formula is: molecular formula : c 28 h 37 fo 7 molecular weight : 504.60 each gram contains 0.64 mg betamethasone dipropionate, usp (equivalent to 0.5 mg betamethasone) in a white to off-white cream of cetomacrogol 1000, cetostearyl alcohol, mineral oil, purified water, sodium phosphate monobasic, white petrolatum and chlorocresol is present as preservative. image
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 (see dosage and administration ).
Read more... 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. 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 (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.
How Supplied:
How supplied product: 50090-4679 ndc: 50090-4679-0 15 g in a tube / 1 in a carton
Information for Patients:
Information for patients patients using topical corticosteroids should receive the following information and instructions: this medication is to be used as directed by the physician. it is for external use only. avoid contact with the eyes. patients should be advised not to use this medication for any disorder other than that for which it was prescribed. the treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive. patients should report any signs of local adverse reactions. parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings (see dosage and administration ).
Package Label Principal Display Panel:
Betamethasone dipropionate label image