NDC 0536-1222 Ketotifen Fumarate

Ketotifen Fumarate

NDC Product Code 0536-1222

NDC 0536-1222-40

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 5 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Ketotifen Fumarate with NDC 0536-1222 is a a human over the counter drug product labeled by Rugby Laboratories. The generic name of Ketotifen Fumarate is ketotifen fumarate. The product's dosage form is solution and is administered via ophthalmic form.

Labeler Name: Rugby Laboratories

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.


Ketotifen Fumarate 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.

  • KETOTIFEN FUMARATE .25 mg/mL

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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Administration Route(s)

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

  • Ophthalmic - Administration to the external eye.

Product Labeler Information

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

Labeler Name: Rugby Laboratories
Labeler Code: 0536
FDA Application Number: ANDA077354 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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: 04-24-2019 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’.

* Please review the disclaimer below.

Information for Patients

Ketotifen Ophthalmic

Ketotifen Ophthalmic is pronounced as (kee toe tye' fen)

Why is ketotifen ophthalmic medication prescribed?
Ophthalmic ketotifen is used to relieve the itching of allergic pinkeye. Ketotifen is in a class of medications called antihistamines. It works by blocking histamine, a s...
[Read More]

* Please review the disclaimer below.

Ketotifen Fumarate Product Label Images

Ketotifen Fumarate 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 Ingredient

Ketotifen (0.025%)(equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Use

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Warnings

For external use only

Do Not Use

  • If solution changes color or becomes cloudy if you are sensitive to any ingredient in this product to treat contact lens related irritation

When Using This Product

  • Do not touch tip of container to any surface to avoid contamination remove contact lenses before use wait at least 10 minutes before reinserting contact lenses after use replace cap after each use

Stop Use And Ask A Doctor If

  • You experience any of the following:eye pain changes in visionredness of the eye itching worsens or lasts for more than 72 hours

Keep Out Of Reach Of Children.

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

Directions

  • Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day.Children under 3 years of age: Consult a doctor.

Other Information

  • Only for use in the eye.Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Inactive Ingredients

Benzalkonium chloride 0.01%, glycerol, hydrochloric acid and/or sodium hydroxide, and water for injection

* Please review the disclaimer below.

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