Fluocinonide .5 mg/g
Fluocinonide · CREAM · A-S Medication Solutions
Fluocinonide cream is a prescription corticosteroid medication applied directly to the skin to reduce inflammation, itching, and redness associated with various skin conditions. It works by suppressing the immune response in the affected area to help relieve symptoms.
Key Facts
- Brand Name
- Fluocinonide
- Generic Name
- Fluocinonide
- NDC Code (Product)
50090-7923- Manufacturer
- A-S Medication Solutions
- Strength
- .5 mg/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA210554
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 10/01/2017
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 cream is a prescription corticosteroid medication applied directly to the skin to reduce inflammation, itching, and redness associated with various skin conditions. It works by suppressing the immune response in the affected area to help 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. There are 4 other brand versions of Fluocinonide.
What is the NDC code for Fluocinonide .5 mg/g?
The NDC (National Drug Code) for Fluocinonide .5 mg/g is 50090-7923, listed by A-S Medication Solutions.