Betamethasone Valerate
Proficient Rx Lp
Human Prescription Drug
NDC 63187-276Betamethasone Valerate is a human prescription drug labeled by 'Proficient Rx Lp'. National Drug Code (NDC) number for Betamethasone Valerate is 63187-276. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Betamethasone Valerate drug includes Betamethasone Valerate - 1.2 mg/g . The currest status of Betamethasone Valerate drug is Active.
Drug Information:
| Drug NDC: | 63187-276 |
| 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 Valerate |
| 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 Valerate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Proficient Rx Lp |
| 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: | BETAMETHASONE VALERATE - 1.2 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: | 01 Sep, 2002 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 13 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: | ANDA070051 |
| 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: | Proficient Rx LP
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 197409
|
| 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: | 9IFA5XM7R2
|
| 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 |
|---|
| 63187-276-15 | 1 TUBE in 1 CARTON (63187-276-15) / 15 g in 1 TUBE | 02 Feb, 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 valerate betamethasone valerate betamethasone valerate betamethasone mineral oil petrolatum
Indications and Usage:
Indications and usage topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
General Precautions:
General systemic absorption of topical corticosteroids has produced reversible hypothalamicpituitary-adrenal (hpa) axis suppression, manifestations of cushingâs syndrome, hyperglycemia, and glucosuria in some patients. conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of hpa axis suppression by using the urinary free cortisol and acth stimulation tests. if hpa axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. recovery of hpa axis function is generally prompt and complete upon discontinuation of the drug. infrequently, signs and symptoms of steroid withdrawal may occur,
Read more...requiring supplemental systemic corticosteroids. children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see precautions-pediatric use ). if irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. in the presence of dermatological infections, the use of an appropriate anti-fungal or antibacterial agent should be instituted. if a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
Dosage and Administration:
Dosage and administration betamethasone valerate cream 0 . 1% and betamethasone valerate ointment 0 . 1% are generally applied to the affected area as a thin film one to three times daily depending on the severity of the condition. dosage once or twice a day is often effective. occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. if an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
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 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.
Overdosage:
Overdosage topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see precautions ).
Description:
Description betamethasone valerate cream and betamethasone valerate ointment contain betamethasone valerate usp (9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-valerate); its empirical formula is c 27 h 37 fo 6 ; its molecular weight is 476 . 59 (cas registry number 2152-44-5); its structural formula is: each gram of the 0 . 1% cream contains 1 . 2 mg betamethasone valerate (equivalent to 1 . 0 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, phosphoric acid or sodium hydroxide and 4-chloro-m-cresol as a preservative. each gram of the 0 . 1% ointment contains 1 . 2 mg betamethasone valerate (equivalent to 1 . 0 mg betamethasone) in an ointment base consisting of mineral oil, white petrolatum and hydrogenated lanolin. cde26ab8-figure-01
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. thus, occlusive dressings may be
Read more... a valuable therapeutic adjunct for treatment of resistant dermatoses (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.
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. thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (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 b
Read more...ile.
How Supplied:
How supplied betamethasone valerate cream usp, 0 . 1% is supplied in: ⢠15 g (0 . 53 oz) tubes manufactured by actavis mid atlantic llc 1877 kawai road lincolnton, nc 28092 usa form no. 0370/0371 vc2795 rev. 2/06 relabeled by: proficient rx lp thousand oaks, ca 91320
Package Label Principal Display Panel:
Package label.principal display panel 63187-276-15