Hydrocortisone Acetate
Cameron Pharmaceuticals, Limited Liability Company
Human Prescription Drug
NDC 42494-341Hydrocortisone Acetate is a human prescription drug labeled by 'Cameron Pharmaceuticals, Limited Liability Company'. National Drug Code (NDC) number for Hydrocortisone Acetate is 42494-341. This drug is available in dosage form of Suppository. The names of the active, medicinal ingredients in Hydrocortisone Acetate drug includes Hydrocortisone Acetate - 25 mg/1 . The currest status of Hydrocortisone Acetate drug is Active.
Drug Information:
| Drug NDC: | 42494-341 |
| 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: | Hydrocortisone Acetate |
| 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: | Hydrocortisone Acetate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cameron Pharmaceuticals, Limited Liability Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Suppository |
| 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: | HYDROCORTISONE ACETATE - 25 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | RECTAL
|
| 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: | UNAPPROVED DRUG OTHER |
| 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 Apr, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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. |
| 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: | Cameron Pharmaceuticals, Limited Liability Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1291082
|
| 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. |
| UPC: | 0342494341123
|
| UPC stands for Universal Product Code. |
| UNII: | 3X7931PO74
|
| 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 |
|---|
| 42494-341-12 | 1 BLISTER PACK in 1 BOX (42494-341-12) / 12 SUPPOSITORY in 1 BLISTER PACK | 01 Apr, 2022 | N/A | No |
| 42494-341-24 | 2 BLISTER PACK in 1 BOX (42494-341-24) / 12 SUPPOSITORY in 1 BLISTER PACK | 01 Apr, 2022 | 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:
Hydrocortisone acetate hydrocortisone acetate hydrocortisone acetate hydrocortisone c10-18 triglycerides
Indications and Usage:
Indications and usage hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of anorectum, and pruritus ani.
Dosage and Administration:
Dosage and administration for rectal administration. detach one suppository from strip of suppositories. hold suppository upright and carefully separate tabs at top opening and pull downward from the pointed end to expose the suppository. remove the suppository from the pocket. avoid excessive handling of suppository which is designed to melt at body temperature. insert one suppository rectally, pointed end first. insert one suppository in the rectum twice daily, morning and night for two weeks, in nonspecific proctitis. in more severe cases, one suppository three times a day or two suppositories twice daily. in factitial proctitis, the recommended duration of therapy is six to eight weeks or less, according to the response of the individual case.
Contraindications:
Contraindications hydrocortisone acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components.
Adverse Reactions:
Adverse reactions the following local adverse reactions have been reported with hydrocortisone acetate suppositories; burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, secondary infection. to report an adverse event, please contact cameron pharmaceuticals, llc at 1-888-767-7913.
Use in Pregnancy:
Pregnancy category c in laboratory animals, topical steroids have been associated with an increase in the incidence of fetal abnormalities when gestating females have been exposed to rather low dosage levels. there are no adequate and well-controlled studies in pregnant women. hydrocortisone acetate suppositories should only be used during pregnancy if the potential benefit justifies the risk of the fetus. drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. it is not known whether this drug is excreted in human milk, and because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocortisone acetate suppositories, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Overdosage:
Overdosage if signs and symptoms of systemic overdosage occur, discontinue use.
Description:
Description hydrocortisone acetate is a corticosteroid designed chemically as pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β) with the following structural formula: each suppository for rectal administration contains hydrocortisone acetate, usp 25 mg in a specially blended hydrogenated vegetable base. chemical structure
Clinical Pharmacology:
Clinical pharmacology in normal subjects, about 26% of hydrocortisone acetate is absorbed when the hydrocortisone acetate suppository is applied to the rectum. absorption of hydrocortisone acetate may vary across abraded or inflamed surfaces. topical steroids are primarily effective because of their anti-inflammatory, anti-pruritic and vasoconstrictive action.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis no long-term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories.
How Supplied:
How supplied hydrocortisone acetate suppositories 25mg are off-white, smooth surfaced and bullet shaped with one pointed end. box of 12 suppositories, ndc 42494-341-12 box of 24 suppositories, ndc 42494-341-24 storage store at 20°-25°c (68°-77°f) [see usp controlled room temperature]. excursions permitted to 15°-30°c (59°-86°f). store away from heat. protect from freezing. avoid contact with eyes. keep this and all drugs out of the reach of children. in case of accidental ingestion, seek professional assistance or contact a poison control center immediately.
Package Label Principal Display Panel:
Principal display panel - 25 mg suppository blister pack box ndc 42494-341-12 cameron pharmaceuticals ⢠hydrocortisone acetate suppositories 25 mg for rectal use only 12 suppositories unit dose rx only principal display panel - 25 mg suppository blister pack box