Fluocinonide .5 mg/mL
Fluocinonide · SOLUTION · Saptalis Pharmaceuticals, LLC.
Fluocinonide is a prescription corticosteroid solution applied directly to the skin to reduce inflammation and itching from various skin conditions. It comes as a liquid formulation at a strength of 0.5 mg/mL.
Key Facts
- Brand Name
- Fluocinonide
- Generic Name
- Fluocinonide
- NDC Code (Product)
71656-094- Manufacturer
- Saptalis Pharmaceuticals, LLC.
- Strength
- .5 mg/mL
- Dosage Form
- SOLUTION
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA207554
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 05/11/2026
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 directly to the skin to reduce inflammation and itching from various skin conditions. It comes as a liquid formulation at a strength of 0.5 mg/mL.
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. There are 4 other brand versions of Fluocinonide.
What is the NDC code for Fluocinonide .5 mg/mL?
The NDC (National Drug Code) for Fluocinonide .5 mg/mL is 71656-094, listed by Saptalis Pharmaceuticals, LLC..