FLUOCINONIDE .5 mg/g Gel — NDC 45802-761-30 (Billing 45802-0761-30)
This is a package of FLUOCINONIDE .5 mg/g Gel from Padagis Israel Pharmaceuticals Ltd, marketed since Apr 2025 and currently FDA-listed; retail pharmacies pay about $1.02 per g (NADAC).
NDC database record
One package, one record: these facts belong to NDC 45802-761-30 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 45802 labeler · 761 product · 30 package
- Package marketed since
- Apr 10, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 4580276130 9
- Medicaid fills, this package
- 50 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Other active recalls for Fluocinonide (different manufacturers) — 3 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 007615
- GCN: 31380
- GPI-14 (Medi-Span): 90550060004005
- HICL (First Databank): 003318
- AHFS class code: 84:06.08.00
- RxCUI (RxNorm): 310362
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Fluocinolone topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Fluocinolone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
Read the full MedlinePlus article ↗- It calms redness, swelling and itching from skin conditions that respond to steroids. The 0.1% creams, including Vanos, are for people 12 and older, and the label specifically desc...
- Use a thin layer on the affected skin only. Follow the schedule on your label and from your prescriber, which differs between the 0.1% creams and the 0.05% products. Don't cover th...
- No. The 0.1% creams are not for the face, groin or underarms. Also keep all of it out of your eyes, mouth and vagina.
- The 0.1% creams are not recommended beyond 2 consecutive weeks. Stop once the condition is controlled, and tell your doctor if you see no improvement in 2 weeks.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.021 | $30.64 / 30 g |
| Medicaid paysCMS SDUD · 12 mo | $1.48 | $44.39 / 30 g |
| Medicare drug plans payPart D · Q2 2026 | $0.6687 | $20.06 / 30 g |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 45802-0761-15 45802-761-15 | 1 TUBE in 1 CARTON / 15 g in 1 TUBE | $1.08 / g | $16.26 | 2025-04-10 | — | Active |
| 45802-0761-30 You're viewing this | 1 TUBE in 1 CARTON / 30 g in 1 TUBE | $1.02 / g | $30.64 | 2025-04-10 | — | Active |
| 45802-0761-60 45802-761-60 Main listing | 1 TUBE in 1 CARTON / 60 g in 1 TUBE | $0.6004 / g | $36.03 | 2025-04-10 | — | Active |
Per g, this pack runs about 70% above the cheapest pack (NDC 45802-0761-60, $0.6004 vs $1.02 NADAC).
This pack accounts for about 33% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of FLUOCINONIDE .5 mg/g Gel?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Fluocinonide .5 mg/g 00713-0663-15 | Cosette | 1 tube | $0.367 | AB1 | Availability likely | save 64% |
| Fluocinonide .5 mg/g 00093-0262-15 | Teva | 1 tube | $0.367 | AB1 | Discontinued | save 64% |
| Fluocinonide .5 mg/g 51672-1386-01 | Sun | 1 tube | $0.367 | AB1 | Availability likely | save 64% |
| Fluocinonide .5 mg/g 51672-1264-01 | Sun | 1 tube | $0.368 | AB | Availability likely | save 64% |
| Fluocinonide .5 mg/g 00093-0264-15 | Teva | 1 tube | $0.368 | AB | Discontinued | save 64% |
| Fluocinonide .5 mg/g 21922-0064-03 | Encube | 1 tube | $0.472 | AB1 | Availability likely | save 54% |
| Fluocinonide Cream .5 mg/g 69238-1534-02 | Amneal | 1 tube | $0.472 | AB1 | Availability likely | save 54% |
| Fluocinonide .5 mg/g 00713-0664-15 | Cosette | 1 tube | $0.906 | AB2 | Availability likely | save 11% |
| Fluocinonide .5 mg/g 00093-0263-15 | Teva | 1 tube | $0.906 | AB2 | Discontinued | save 11% |
| Fluocinonide .5 mg/g 51672-1254-01 | Sun | 1 tube | $0.906 | AB2 | Availability likely | save 11% |
| Fluocinonide .5 mg/gthis 45802-0761-30 | Padagis | 1 tube | $1.021 | AB | Availability likely | — |
| Fluocinonide .5 mg/g 51672-1279-01 | Sun | 1 tube | $1.084 | AB | Availability likely | +6% |
| Fluocinonide .5 mg/g 50090-3277-00 | A-S | 1 tube | — | AB1 | FDA listed | — |
| Fluocinonide .5 mg/g 68071-4921-05 | NuCare | 30 g | — | AB1 | FDA listed | — |
| Fluocinonide .5 mg/g 68788-8593-06 | Preferred | 1 tube | — | AB1 | FDA listed | — |
| Fluocinonide .5 mg/g 50090-6309-00 | A-S | 1 tube | — | AB1 | FDA listed | — |
| Fluocinonide .5 mg/g 68071-4219-05 | NuCare | 1 tube | — | AB1 | FDA listed | — |
| Fluocinonide .5 mg/g 68788-8554-06 | Preferred | 1 tube | — | AB | FDA listed | — |
| Fluocinonide .5 mg/g 66267-0973-15 | NuCare | 15 g | — | AB1 | FDA listed | — |
| Fluocinonide .5 mg/g 68071-2202-05 | NuCare | 1 tube | — | AB | FDA listed | — |
| Fluocinonide .5 mg/g 50090-1784-00 | A-S | 1 tube | — | AB1 | FDA listed | — |
| Fluocinonide .5 mg/g 50090-7923-00 | A-S | 1 tube | — | AB1 | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Fluocinonide inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 4Q93RCW27E
A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
-
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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UNII 8D4SNN7V92
Propyl gallate is a synthetic antioxidant derived from gallic acid. It prevents oils and fats in the medicine from oxidizing and spoiling, helping the product stay stable and effective during storage.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Padagis Israel Pharmaceuticals Ltd labeler code 45802
- acetaminophen pain reliever fever reducer 650 mg Suppository NDC 45802-730-00
- acetaminophen for children 120 mg Suppository NDC 45802-732-30
- clindamycin phosphate and benzoyl peroxide 10 mg/g; 50 mg/g Gel NDC 45802-736-84
- testosterone 16.2 mg/g Gel NDC 45802-754-01
- Promethazine Hydrochloride 12.5 mg Suppository NDC 45802-758-30
- Promethazine Hydrochloride 25 mg Suppository NDC 45802-759-30
- desoximetasone 2.5 mg/mL Spray NDC 45802-807-98
- Calcipotriene and Betamethasone Dipropionate 50 ug/g; .643 mg/g Ointment NDC 45802-816-01
- triamcinolone acetonide .5 mg/g Ointment NDC 45802-817-01
- nicotine 2 mg Gum, Chewing NDC 45802-827-25
- adapalene and benzoyl peroxide .1 g/100g; 2.5 g/100g Gel NDC 45802-846-01
- Fexofenadine Hydrochloride 180 mg Tablet, Film Coated NDC 45802-847-78
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Fluocinonide Gel USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Fluocinonide Gel USP, 0.05% is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
⛔ Contraindications ▾
CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
🤒 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 Hypertrichosis Maceration of the Skin Itching Acneiform Eruptions Secondary Infection Irritation Hypopigmentation Skin Atrophy Dryness Perioral Dermatitis Striae Folliculitis Allergic Contact Dermatitis Miliaria To report SUSPECTED ADVERSE REACTIONS , contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🤰 Pregnancy ▾
Pregnancy Category C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids.
Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
🧒 Pediatric Use ▾
Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio. HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation.
Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
🆘 Overdosage ▾
OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids.
There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin.
Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION ).
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys.
Some of the topical corticosteroids and their metabolites are also excreted into the bile.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Fluocinonide Gel USP, 0.05% is supplied in the following: 15 g (NDC 45802- 761 -15) 30 g (NDC 45802- 761 -30) and 60 g (NDC 45802- 761 -60) tubes. Store at 20°- 25°C (68°- 77°F) [see USP Controlled Room Temperature] Manufactured by Padagis®, Yeruham, Israel www.padagis.com Rev 08-24 7D000 RC PH2
📋 Description ▾
DESCRIPTION Fluocinonide Gel USP, 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6a,11b,16a)-. It has the following chemical structure: Mol.
Formula: C 26 H 32 F 2 O 7 Mol. Wt: 494.53 Fluocinonide Gel USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 980, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible.
In the Fluocinonide Gel USP, 0.05% formulation, the active ingredient is totally in solution. fluocinonide chemical structure
💬 Information for Patients ▾
Information for the Patient Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only.
Avoid contact with the eyes. 2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. 4.
Patients should report any signs of local adverse reactions, especially under occlusive dressing. 5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.
⚠️ Precautions ▾
PRECAUTIONS General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS - Pediatric Use ). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. As with any topical corticosteroid product, prolonged use may produce atrophy of the skin and subcutaneous tissues.
When used on intertriginous or flexor areas, or on the face, this may occur even with short-term use. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
Information for the Patient Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only.
Avoid contact with the eyes. 2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. 4.
Patients should report any signs of local adverse reactions, especially under occlusive dressing. 5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.
Laboratory Tests The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Pregnancy Category C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels.
The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a d… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
🧬 Pharmacokinetics ▾
Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.
Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION ). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.
Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.
📄 Package Label / Principal Display Panel ▾
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 45802-761-30 Rx Only Fluocinonide Gel USP, 0.05% For External Use Only. Not For Ophthalmic Use. NET WT 30 g Fluocinonide Gel USP, 0.05% carton image