Zaditor
Ketotifen Fumarate
Alcon Laboratories, Inc.
Human Otc Drug
NDC 0065-4011Zaditor also known as Ketotifen Fumarate is a human otc drug labeled by 'Alcon Laboratories, Inc.'. National Drug Code (NDC) number for Zaditor is 0065-4011. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Zaditor drug includes Ketotifen Fumarate - .25 mg/mL . The currest status of Zaditor drug is Active.
Drug Information:
| Drug NDC: | 0065-4011 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Zaditor |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Ketotifen Fumarate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Alcon Laboratories, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | KETOTIFEN FUMARATE - .25 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | OPHTHALMIC
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 21 Dec, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA077200 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Alcon Laboratories, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 284380
311237
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0300654011057
|
| UPC stands for Universal Product Code. |
| UNII: | HBD503WORO
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Inhibitor [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0065-4011-05 | 1 BOTTLE, DROPPER in 1 CARTON (0065-4011-05) / 5 mL in 1 BOTTLE, DROPPER | 21 Dec, 2012 | N/A | No |
| 0065-4011-06 | 2 BOTTLE, DROPPER in 1 CARTON (0065-4011-06) / 5 mL in 1 BOTTLE, DROPPER | 21 Dec, 2012 | N/A | No |
| 0065-4011-11 | 3 BOTTLE, DROPPER in 1 CARTON (0065-4011-11) / 5 mL in 1 BOTTLE, DROPPER | 21 Dec, 2012 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Active ingredient purpose ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%) antihistamine
Product Elements:
Zaditor ketotifen fumarate ketotifen fumarate ketotifen benzalkonium chloride glycerin sodium hydroxide hydrochloric acid water carton2 zaditor carton
Indications and Usage:
Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
Warnings:
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:
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
Dosage and Administration:
Directions adults and children 3 years of age and older: put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day. children under 3 years of age: consult a doctor
Stop Use:
Stop use and ask a doctor if you experience any of the following: eye pain changes in vision redness of the eye itching worsens or lasts for more than 72 hours
Package Label Principal Display Panel:
Package label.principal display panel systane ® zaditor ® ketotifen fumarate ophthalmic solution 0.035% antihistamine eye drops eye itch relief works in minutes original prescription strength for ages 3 years and older up to 12 hours alcon sterile 30 day supply 5ml (0.17 fl oz) systane® zaditor® original prescription strength up to 12 hour itch relief works in minutes for ages 3 years and older 30 day supply tamper evident: for your protection, this bottle has a seal imprinted with alcon around the neck. do not use if seal is damaged or missing at time of purchase. alcon laboratories, inc. fort worth, tx 76134 usa country of origin: italy 300048650-0821 actual size lot: exp.: systane ® zaditor ® ketotifen fumarate ophthalmic solution 0.035% antihistamine eye drops eye itch relief ? works in minutes ? original prescription strength ? for ages 3 years and older up to 12 hours alcon sterile 30 day supply 5ml (0.17 fl oz) systane ® zaditor ® original prescription strength up to 12 hour itch relief works in minutes for ages 3 years and older 30 day supply tamper evident: for your protection, this bottle has a seal imprinted with alcon around the neck. do not use if seal is damaged or missing at time of purchase. alcon laboratories, inc. fort worth, tx 76134 usa a novartis division country of origin: italy 9016645-0918 actual size lot: exp.:
Further Questions:
Questions? in the us, call toll-free 1-800-757-919 5 alcon.medinfo@alcon.com www.systane.com serious side effects associated with use of this product may be reported to this number.