NDC 70795-2412 Hydrocortisone Acetate

Hydrocortisone Acetate

NDC Product Code 70795-2412

NDC CODE: 70795-2412

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.

Product Characteristics

Color(s):
YELLOW (C48330 - OFF-WHITE)
Shape: BULLET (C48335)

NDC Code Structure

NDC 70795-2412-1

Package Description: 12 SUPPOSITORY in 1 CARTON

NDC 70795-2412-2

Package Description: 24 SUPPOSITORY in 1 CARTON

NDC Product Information

Hydrocortisone Acetate with NDC 70795-2412 is a a human prescription drug product labeled by Graxcell Pharmaceutical, Llc.. 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: 1291082.

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 COCO-GLYCERIDES (UNII: XDD37N2GPR)

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: Graxcell Pharmaceutical, Llc.
Labeler Code: 70795
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: 10-18-2017 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: 12-31-2021 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".

* Please review the disclaimer below.

Information for Patients

Hydrocortisone Topical

Hydrocortisone Topical is pronounced as (hye droe kor' ti sone)

Why is hydrocortisone topical medication prescribed?
Hydrocortisone is available with or without a prescription. Low-strength preparations (0.5% or 1%) are used without a prescription for the temporary relief of (1) minor s...
[Read More]

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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

Graxcell Pharmaceutical, Llc. Disclaimer: This Drug Has Not Been Found By Fda To Be Safe And Effective, And This Labelling Has Not Been Approved By Fda. Hydrocortisone Acetae, 25Mg. Rectal Suppositories.

Hydrocortisone Acetate is a corticosteroid designated chemically as pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β) with the following structural formula:Each rectal suppository contains hydrocortisone acetate, USP 25 mg in a specially blended hydrogenated vegetable oil base

Clinical Pharmacology

In normal subjects, about 26% of hydrocortisone acetate is absorbed when the 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 vasconstrictive action.

Indications & Usage

Hydrocortisone acetate suppositories are indicated for the use in inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and puritus ani.

Contraindications

Hydrocortisone Acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or 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, the corticosteroid should be discontinued until the infection has been adequately controlled.Carcinogenic: No long-term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories.

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 suspected adverse reactions, contactGraxcell pharmaceutical, llc.1-888-266-8818 orFDA @ 1-800-FDA-1088 orwww.fda.gov/medwatch

Overdosage

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

Dosage & Administration

Usual Dosage: One suppository in the rectum 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 in six to eight weeks or less, according to the response of the individual case.Rx only.OPENING INSTRUCTIONSAvoid excessive handling of the suppository. It is designed to melt at body temperature.1. Separate plastic film at top opening and pull downward.2. Continue pulling downward to almost the full length of the suppository.3. Gently remove the suppsitory from the film pocket.

How Supplied

Hydrocortisone Acetate suppositories 25mg are white,cyclinder shaped, with one end tapered.Package of 12 NDC 70795-2412-1andPackage of 24 NDC 70795-2412-2

Storage And Handling

Store at 20º-25ºC (68º-77ºF) [See USP Controlled Room Temperature]. Store away from heat. Protect from freezing.Manufactured for:Graxcell pharmaceutical, LLC.130 knickerbocker ave,Bohemia, NY 11716Manufactured by:Graxcell pharmaceutical, llc.136 OAk Drive,syosset, NY 117911-888-266-8818.

Drug Abuse And Dependence

Drug abuse and dependece have not been reported in patients treated with Hydrocortisone acetate suppositories.

* Please review the disclaimer below.