Ketotifen Fumarate .25 mg/mL
Ketotifen Fumarate · SOLUTION/ DROPS · Rugby Laboratories
Ketotifen Fumarate is a solution/ drops containing ketotifen fumarate at .25 mg/mL, taken ophthalmic. Manufactured by Rugby Laboratories.
Key Facts
- Brand Name
- Ketotifen Fumarate
- Generic Name
- Ketotifen Fumarate
- NDC Code (Product)
0536-1252- Manufacturer
- Rugby Laboratories
- Strength
- .25 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA021996
- Marketing Start
- 09/18/2020
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
RemedyRepack Inc.
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Akorn, Inc.
CGMP Deviations
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Frequently Asked Questions
What is Ketotifen Fumarate used for?
Ketotifen Fumarate contains Ketotifen Fumarate. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Ketotifen Fumarate a controlled substance?
Ketotifen Fumarate is not classified as a controlled substance by the DEA.
What is the generic name for Ketotifen Fumarate?
The generic name for Ketotifen Fumarate is Ketotifen Fumarate. There are 12 other brand versions of Ketotifen Fumarate.
What is the NDC code for Ketotifen Fumarate .25 mg/mL?
The NDC (National Drug Code) for Ketotifen Fumarate .25 mg/mL is 0536-1252, listed by Rugby Laboratories.
Other Ketotifen Brands
See all →- Ketotifen Fumarate Ophthalmic Solution.25 mg/mL72485-617
- Eye Itch Relief.25 mg/mL69842-275
- Eye Itch Relief.35 mg/mL70000-0124
- KETOTIFEN FUMARATE.25 mg/mL76385-106
- Zaditor.25 mg/mL0065-4011
- Eye Itch Releif.25 mg/mL11822-5533
- Eye Itch Relief.25 mg/mL21130-601
- Alaway.25 mg/mL24208-601
- Eye Itch Relief.25 mg/mL36800-097
- Eye Itch Relief.25 mg/mL50804-601
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)