Hydrocortisone Acetate
Marlex Pharmaceuticals, Inc.
Human Prescription Drug
NDC 10135-751Hydrocortisone Acetate is a human prescription drug labeled by 'Marlex Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Hydrocortisone Acetate is 10135-751. 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: | 10135-751 |
| 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: | Marlex Pharmaceuticals, Inc. |
| 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 Aug, 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: | Marlex Pharmaceuticals, Inc.
|
| 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. |
| 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 |
|---|
| 10135-751-12 | 12 SUPPOSITORY in 1 CARTON (10135-751-12) | 01 Aug, 2022 | N/A | No |
| 10135-751-24 | 24 SUPPOSITORY in 1 CARTON (10135-751-24) | 01 Aug, 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 hydrogenated palm oil (white to off-white)
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 the anorectum, and pruritus ani.
Dosage and Administration:
Dosage and administration for rectal administration: insert one suppository in the rectum twice daily, morning and night for two weeks, in nonspecific proctitis.ln 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. detach and hold one suppository upright(point upward). separate tabs at top opening and pull downward to almost the full length of the suppository. carefully remove the suppository, avoiding excessive handling, which is designed to melt at body temperature. insert suppository into the rectum, pointed end first, with gentle pressure.
Contraindications:
Contraindications hydrocortisone acetate suppositories are contraindicated in those patients with a history of hypersensitivity to 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, and secondary infection. to report suspected adverse reactions, contact marlex pharmaceuticals at 1-888-582-1953 or drugsafety@marlexpharm.com or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
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 to 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. 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.
Description:
Description each hydrocortisone acetate suppository for rectal administration contains hydrocortisone acetate usp in a hydrogenated palm kernel oil base. hydrocortisone acetate is a corticosteroid. the molecular weight of hydrocortisone acetate is 404.50. chemically, hydrocortisone acetate is pregn-4-ene-3, 20 dione, 21- (acetyloxy)-11, 17-dihydroxy-, (11β)- with an empirical formula of c23 h32o6 and the following structural formula: struct
Clinical Pharmacology:
Clinical pharmacology in normal subjects, about 26 percent 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, antipruritic 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 25mg (12 count) ndc 10135-0751-12 25mg (24 count) ndc 10135-0751-24 store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. store away from heat. protect from freezing. manufactured for/ distributed by: marlex pharmaceuticals, inc. new castle, de 19720 rev. 07/22 id
Package Label Principal Display Panel:
Principal display panel - 25 mg suppository carton ndc 10135-0751-12 rx only hydrocortisone acetate suppositories 25 mg for rectal use only 12 suppositories 12-count
Principal display panel - 25 mg suppository carton ndc 10135-0751-24 rx only hydrocortisone acetate suppositories 25 mg for rectal use only 24 suppositories 24-count