Fluocinonide .5 mg/mL
fluocinonide topical solution usp, 0.05% · SOLUTION · Bryant Ranch Prepack
Fluocinonide is a prescription corticosteroid solution applied to the skin to reduce inflammation and itching caused by various skin conditions. It works by decreasing immune system activity in the affected area to relieve symptoms.
Key Facts
- Brand Name
- Fluocinonide
- Generic Name
- fluocinonide topical solution usp, 0.05%
- NDC Code (Product)
63629-9583- Manufacturer
- Bryant Ranch Prepack
- Strength
- .5 mg/mL
- Dosage Form
- SOLUTION
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA209699
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 04/19/2019
Recall History
Taro Pharmaceuticals U.S.A., Inc.
Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Taro Pharmaceuticals U.S.A., Inc.
Cross contamination with other products: traces of Dapsone were found in the finished product.
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Reliable Rexall-A Compounding Pharmacy
Lack of Processing Controls
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Teligent Pharma, Inc.
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
Teligent Pharma, Inc.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Synergy Rx
Lack of Assurance of Sterility: There are also CGMP Deviations.
Teligent Pharma, Inc.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Full prescribing information not available for this product.
Frequently Asked Questions
What is Fluocinonide used for?
Fluocinonide is a prescription corticosteroid solution applied to the skin to reduce inflammation and itching caused by various skin conditions. It works by decreasing immune system activity in the affected area to relieve symptoms.
Is Fluocinonide a controlled substance?
Fluocinonide is not classified as a controlled substance by the DEA.
What is the generic name for Fluocinonide?
The generic name for Fluocinonide is fluocinonide topical solution usp, 0.05%. There are no other listed brand versions of fluocinonide topical solution usp, 0.05%.
What is the NDC code for Fluocinonide .5 mg/mL?
The NDC (National Drug Code) for Fluocinonide .5 mg/mL is 63629-9583, listed by Bryant Ranch Prepack.
Other Fluocinonide Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)