NDC 68428-343 Cortisone Aceticum

Cortisone Acetate

NDC Product Code 68428-343

NDC CODE: 68428-343

Proprietary Name: Cortisone Aceticum 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: Cortisone 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.

Cortisone is a corticosteroid hormone (glucocorticoid). It decreases your body's natural defensive response and reduces symptoms such as swelling and allergic-type reactions. This medication is used to treat conditions such as arthritis, blood/hormone/immune system disorders, allergic reactions, certain skin and eye conditions, breathing problems, and certain cancers.

NDC Code Structure

NDC 68428-343-03

Package Description: 75 PELLET in 1 VIAL, GLASS

NDC 68428-343-05

Package Description: 150 PELLET in 1 VIAL, GLASS

NDC 68428-343-06

Package Description: 1200 PELLET in 1 BOTTLE, GLASS

NDC 68428-343-11

Package Description: 300 PELLET in 1 BOTTLE, GLASS

NDC 68428-343-12

Package Description: 600 PELLET in 1 BOTTLE, GLASS

NDC Product Information

Cortisone Aceticum with NDC 68428-343 is a a human over the counter drug product labeled by Washington Homeopathic Products. The generic name of Cortisone Aceticum is cortisone acetate. The product's dosage form is pellet and is administered via oral form.

Labeler Name: Washington Homeopathic Products

Dosage Form: Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.

Product Type: Human Otc 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.

Cortisone Aceticum 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.

  • CORTISONE ACETATE 30 [hp_C]/1

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.

  • SUCROSE (UNII: C151H8M554)
  • LACTOSE (UNII: J2B2A4N98G)

Administration Route(s)

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

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Washington Homeopathic Products
Labeler Code: 68428
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 05-13-2010 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Cortisone Aceticum 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

Active Ingredients

CORTISONE ACETICUM

Uses

To relieve the symptoms of indigestion.

Keep Out Of Reach Of Children

Keep this and all medicines out of reach of children.

Indications

Indications:CORTISONE ACETICUM   Indigestion

Stop Use And Ask Doctor

If symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner.

Directions

Adults: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides. Children: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.

Inactive Ingredients

Sucrose/Lactose

* Please review the disclaimer below.