NDC 0498-0801 Hydrocortisone

Anti-itch

NDC Product Code 0498-0801

NDC 0498-0801-01

Package Description: 1728 PACKET in 1 CARTON > .9 g in 1 PACKET

NDC 0498-0801-02

Package Description: 144 PACKET in 1 BOX, UNIT-DOSE > .9 g in 1 PACKET

NDC 0498-0801-03

Package Description: 25 PACKET in 1 BOX, UNIT-DOSE > .9 g in 1 PACKET

NDC 0498-0801-32

Package Description: 20 PACKET in 1 BOX, UNIT-DOSE > .9 g in 1 PACKET

NDC 0498-0801-33

Package Description: 100 PACKET in 1 BOX, UNIT-DOSE > .9 g in 1 PACKET

NDC 0498-0801-34

Package Description: 10 PACKET in 1 BOX, UNIT-DOSE > .9 g in 1 PACKET

NDC 0498-0801-35

Package Description: .9 g in 1 PACKET

NDC Product Information

Hydrocortisone with NDC 0498-0801 is a a human over the counter drug product labeled by Honeywell Safety Products Usa, Inc. The generic name of Hydrocortisone is anti-itch. The product's dosage form is cream and is administered via topical form.

Labeler Name: Honeywell Safety Products Usa, Inc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Hydrocortisone 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.

  • HYDROCORTISONE ACETATE 1 g/100g

Administration Route(s)

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

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Honeywell Safety Products Usa, Inc
Labeler Code: 0498
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 10-15-2019 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’.

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Information for Patients

Hydrocortisone Topical

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

Why is hydrocortisone topical medication prescribed?
Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone is in a class of medications called corticos...
[Read More]

* Please review the disclaimer below.