Betamethasone Dipropionate
A-s Medication Solutions
Human Prescription Drug
NDC 50090-1839Betamethasone Dipropionate is a human prescription drug labeled by 'A-s Medication Solutions'. National Drug Code (NDC) number for Betamethasone Dipropionate is 50090-1839. 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: | 50090-1839 |
| 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: | 03 Sep, 2002 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 01 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: | ANDA070885 |
| 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 |
|---|
| 50090-1839-0 | 1 TUBE in 1 CARTON (50090-1839-0) / 45 g in 1 TUBE | 21 May, 2015 | 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 water mineral oil petrolatum polyethylene glycol 1000 cetostearyl alcohol sodium phosphate, monobasic, unspecified form propylene glycol phosphoric acid sodium hydroxide chlorocresol
Indications and Usage:
Indications and usage betamethasone dipropionate cream is a medium-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.
Dosage and Administration:
Dosage and administration apply a thin film of betamethasone dipropionate cream 0 . 05% to the affected skin areas once daily. in some cases, a twice-daily dosage may be necessary. betamethasone dipropionate cream is not to be used with occlusive dressings.
Contraindications:
Contraindications betamethasone dipropionate cream is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.
Adverse Reactions:
Adverse reactions the following local adverse reactions are reported infrequently when betamethasone dipropionate cream is 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 infection, skin atrophy, striae, miliaria. adverse reactions reported to be possibly or probably related to treatment with betamethasone dipropionate cream during a pediatric clinical study include signs of skin atrophy (bruising, shininess). skin atrophy occurred in 3 of 63 (5%) patients, a 3-year old, a 5-year old, and a 7-year old. systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (hpa) axis suppression, manifestations of cushingâs syndrome, hyperglycemia, and glucosuria in some pa
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Overdosage:
Overdosage topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see precautions ).
Description:
Description betamethasone dipropionate cream contains betamethasone dipropionate, usp, a synthetic adrenocorticosteroid, for dermatologic use. betamethasone, an analog of prednisolone, has high corticosteroid activity and slight mineral-ocorticoid activity. betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone. chemically, betamethasone dipropionate is 9-fluoro-11 β, 17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula c 28 h 37 fo 7 , a molecular weight of 504 . 6, and the following structural formula: betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. each gram of betamethasone dipropionate cream 0 . 05% contains: 0 . 64 mg betamethasone dipropionate usp (equivalent to 0 . 5 mg betamethasone) in a hydrophilic cream base consisting of purified water, mineral oil, white petrolatum, polyethylene glycol 1000 monocetyl ether, cetostearyl alcohol, monobasic sodium phosphate, propylene glycol, phosphoric acid and/or sodium hydroxide for ph adjustment and chlorocresol as a preservative. structure
Clinical Pharmacology:
Clinical pharmacology the corticosteroids are a class of compounds comprising steroid hormones, secreted by the adrenal cortex and their synthetic analogs. in pharmacologic doses corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects. topical corticosteroids, such as betamethasone dipropionate, are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions. however, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. betamethasone dipropionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs. pharmacokinetics: the extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integr
Read more...ity of the epidermal barrier, and the use of occlusive dressings (see dosage and administration ). 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. sixty-three pediatric patients ages 1 to 12 years, with atopic dermatitis, were enrolled in an open-label, hypothalamic-pituitary-adrenal (hpa) axis safety study. betamethasone dipropionate cream was applied twice daily for 2 to 3 weeks over a mean body surface area of 40% (range 35% to 90%). in 10 of 43 (23%) evaluable patients, adrenal suppression was indicated by either a less than or equal to 5 mcg/dl pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol less than or equal to 18 mcg/dl and/or an increase of less than 7 mcg/dl from the baseline cortisol. studies performed with betamethasone dipropionate cream indicate that it is in the medium range of potency as compared with other topical corticosteroids.
How Supplied:
How supplied product: 50090-1839 ndc: 50090-1839-0 45 g in a tube / 1 in a carton
Package Label Principal Display Panel:
Betamethasone dipropionate label image