NDC 0713-0493 Hydrocortisone Acetate

Hydrocortisone Acetate

NDC Product Code 0713-0493

NDC CODE: 0713-0493

Proprietary Name: Hydrocortisone Acetate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Hydrocortisone Acetate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat hemorrhoids and itching/swelling in the rectum and anus. It is also used with other medications to treat certain intestinal problems (such as ulcerative colitis of the rectum and other rectal/anal inflammatory conditions). Hydrocortisone suppositories help to relieve rectal pain, itching, bloody diarrhea, and bleeding by reducing swelling (inflammation) directly in the rectum and anus. Hydrocortisone belongs to a class of drugs called corticosteroids.

NDC Code Structure

  • 0713 - Cosette Pharmaceuticals, Inc.

NDC 0713-0493-12

Package Description: 12 PACKET in 1 BOX > 1 SUPPOSITORY in 1 PACKET

NDC Product Information

Hydrocortisone Acetate with NDC 0713-0493 is a a human prescription drug product labeled by Cosette Pharmaceuticals, Inc.. The generic name of Hydrocortisone Acetate is hydrocortisone acetate. The product's dosage form is suppository and is administered via rectal form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1291085.

Dosage Form: Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Hydrocortisone Acetate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Rectal - Administration to the rectum.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cosette Pharmaceuticals, Inc.
Labeler Code: 0713
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 08-09-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Hydrocortisone Acetate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Each Hydrocortisone Acetate Suppository for rectal administration contains 30 mg hydrocortisone acetate, USP in a specially blended hydrogenated vegetable 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 C23H32O6 and the following structural formula:

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.

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.

Contraindications

Hydrocortisone Acetate Suppositories are contraindicated in those patients with a history of hypersensitivity to any of the components.

Precautions

Do not use unless adequate proctologic examination is made.If irritation develops, the product should be discontinued and appropriate therapy instituted.In the presence of an infection, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, Hydrocortisone Acetate Suppositories should be discontinued until the infection has been adequately controlled.

Carcinogenesis

No long-term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories.

Pregnancy Category C And Nursing Mothers

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.It is not known whether this drug is excreted in human milk. Since 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 taking the drug, taking into account the importance of the drug to the mother.Until adequate studies in pregnant or lactating women have been conducted, this drug should be used during pregnancy or by nursing mothers only when clearly needed and when the potential benefits outweigh the potential risks to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Adverse Reactions

The following local adverse reactions have been reported with Hydrocortisone Acetate Suppositories:                                         1. Burning   5. Folliculitis                                         2. Itching    6. Hypopigmentation                                         3. Irritation 7. Allergic Contact Dermatitis                                         4. Dryness  8. Secondary InfectionTo report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Abuse And Dependence

Drug abuse and dependence have not been reported in patients treated with Hydrocortisone Acetate Suppositories.

Overdosage

If signs and symptoms of systemic overdosage occur, discontinue use.

Dosage And Administration

Usual dosage: One suppository in the rectum twice daily morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times daily; or two suppositories twice daily. In factitial proctitis, recommended therapy is six to eight weeks or less, according to response.

How Supplied

Hydrocortisone Acetate Suppositories are easy to open and available in cartons of:12's NDC 0713-0493-12

Storage And Handling

Store at controlled room temperature 15° to 30° C (59° to 86° F). Store away from heat. Protect from freezing.

Other

Distributed by:Cosette Pharmaceuticals, Inc.South Plainfield, NJ 070808-0493CPLNC1Iss. 01/2021     VC7545

* Please review the disclaimer below.