NDC 72189-212 Ketotifen Fumarate

Ketotifen Fumarate

NDC Product Code 72189-212

NDC CODE: 72189-212

Proprietary Name: Ketotifen Fumarate 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: Ketotifen Fumarate 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 prevent and treat itching of the eyes caused by allergies (allergic/seasonal conjunctivitis). Ketotifen is an antihistamine for the eye that treats allergic symptoms by blocking a certain natural substance (histamine). It is also a mast cell stabilizer that prevents allergic reactions by reducing the release of natural substances that cause an allergic reaction.

NDC Code Structure

  • 72189 - Direct Rx

NDC 72189-212-05

Package Description: 5 mL in 1 BOTTLE

NDC Product Information

Ketotifen Fumarate with NDC 72189-212 is a a human over the counter drug product labeled by Direct Rx. The generic name of Ketotifen Fumarate is ketotifen fumarate. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Direct Rx

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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 .35 mg/mL

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: Direct Rx
Labeler Code: 72189
FDA Application Number: ANDA077958 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: 05-07-2021 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: 12-31-2022 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.

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

Otc - Active Ingredient

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

Otc - Purpose

Antihistamine

Otc - When Using

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

Warnings

For external use onlyDo not useif 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 productdo 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 ifyou experience any of the following:eye pain

changes in vision

redness 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.

Instructions For Use

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.

Otc - Questions

Only for use in the eye.

Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Inactive Ingredient

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

* Please review the disclaimer below.