NDC 50382-007 Hydrocortisone Acetate

NDC Product Code 50382-007

NDC CODE: 50382-007

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.

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

  • 50382 - Galentic Pharma (india) Private Limited

NDC 50382-007-01

Package Description: 28.4 g in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Hydrocortisone Acetate with NDC 50382-007 is a product labeled by Galentic Pharma (india) Private Limited. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1440184.

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.

  • PARAFFIN (UNII: I9O0E3H2ZE)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)

Product Labeler Information

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

Labeler Name: Galentic Pharma (india) Private Limited
Labeler Code: 50382
Start Marketing Date: 09-06-2011 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: 12-31-2017 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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]

* Please review the disclaimer below.

Hydrocortisone Acetate Product Label Images

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

Otc - Active Ingredient

Active Ingredient                            PurposeHydrocortisone Acetate 1%            Antipruritic (anti-itch)

Purpose

  • Hydrocortisone is for temporary relief of;minor skin irritationsItching and rashes due to; eczemainsect bitespoison ivypoison oakpoison sumacsoapsdetergentscosmeticsjewelryand for external itching of; genitalfeminine andanal itching

Warnings:

For external use only

Indications And Usage:

  • In the eyeslonger than 1 week unless directed by a physicianfor diaper rashif you have vaginal dischargemore than the recommended daily dosage unless directed by a doctorin the rectum bu using fingers or any other mechanical device or applicatorFor temporary relief of minor skin irritations and external itching.

Stop Use And Ask A Physician If:

  • The condition persists or gets worsesymptoms clear up and occur again within a few daysyou are pregnant or breast feeding

Keep Out Of Reach Of Children

  • If swallowed, get medical help or contact a Poison Control Center right away.

Dosage And Administration:

  • Adults and children over 2 years of ageApply evenly to affected area no more than 3 or 4 times daily.Children under 2 years of ageDo not useconsult a physicianAdultsWhen practical, cleanse the affected area with mild soap and warm water and rinse thoroughlyGently dry, patting and blotting with bathroom tissue or soft cloth before applyingapply externally to the area up to 6 times daily or after each bowel movement

Other Information:

  • Store at 20 deg - 25 deg C (68 deg - 77 deg F)Avoid excessive heat and humidity

Inactive Ingredients:

Liquid Paraffin, White Soft Paraffin

* Please review the disclaimer below.