Desoximetasone 2.5 mg/mL
Desoximetasone · SPRAY · Lupin Pharmaceuticals, Inc.
Desoximetasone is a spray containing desoximetasone at 2.5 mg/mL, taken topical. Manufactured by Lupin Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Desoximetasone
- Generic Name
- Desoximetasone
- NDC Code (Product)
68180-944- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Strength
- 2.5 mg/mL
- Dosage Form
- SPRAY
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA208124
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 07/20/2018
Recall History
Akorn Inc
Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
Taro Pharmaceuticals, Inc.
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Teligent Pharma, Inc.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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.
American Pharmaceutical Ingredients LLC
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Taro Pharmaceuticals, Inc.
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specification; high out of specification results observed
Teligent Pharma, Inc.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Teligent, Inc.
Superpotent Drug
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
Indications & Usage
INDICATIONS AND USAGE Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
DOSAGE AND ADMINISTRATION Apply a thin film of desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, or desoximetasone gel USP, 0.05% to the affected skin areas twice daily. Rub in gently.
Warnings
WARNINGS Keep out of reach of children.
Contraindications
CONTRAINDICATIONS Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Adverse Reactions
ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. In controlled clinical studies the incidence of adverse reactions were low (0.8%) for desoximetasone cream USP, 0.25%, and included burning, folliculitis, and folliculo-pustular lesions. The incidence of adverse reactions were also 0.8% for desoximetasone cream USP, 0.05% and included pruritus, erythema, vesiculation, and burning sensation. The incidence of adverse reactions for desoximetasone gel USP, 0.05% was 0.3% with one subject reporting stinging and burning at the site of application.
Frequently Asked Questions
What is Desoximetasone used for?
Desoximetasone contains Desoximetasone. It is a spray taken topical. Consult your doctor for specific uses.
Is Desoximetasone a controlled substance?
Desoximetasone is not classified as a controlled substance by the DEA.
What is the generic name for Desoximetasone?
The generic name for Desoximetasone is Desoximetasone. There are 6 other brand versions of Desoximetasone.
What is the NDC code for Desoximetasone 2.5 mg/mL?
The NDC (National Drug Code) for Desoximetasone 2.5 mg/mL is 68180-944, listed by Lupin Pharmaceuticals, Inc..