Clobetasol Propionate ANDA .5 mg/g Ointment
Other active recalls for Clobetasol Propionate (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- Clobetasol is a very strong prescription steroid cream (or foam, spray, shampoo, solution, or eye drop) used to calm inflamed, itchy skin. Depending on the specific product, it tre...
- That's a really important question. Most clobetasol skin products should be used for no more than 2 consecutive weeks. Some formulations can be extended to 4 weeks for certain case...
- How long can I use this? I've heard you can't use steroids for too long.
- Do not apply clobetasol to your face, underarms, or groin unless your doctor has specifically told you to — those areas absorb much more of the medication. Also avoid any skin that...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Clobetasol Propionate — tap one for details:
Clobetasol may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 4T6H12BN9U
Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
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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.
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UNII 0W8RRI5W5A
A fatty acid derivative used as an emulsifier and surfactant in medications. It helps blend oily and water-based ingredients together to create a stable, uniform product.
3 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.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 | $0.171 | $5.13 / 30 g |
| Medicaid paysCMS SDUD · 12 mo | $0.4290 | $12.87 / 30 g |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Clobetasol Propionate .5 mg/g 00713-0656-15 | Cosette | 1 tube | $0.129 | AB | Availability likely | save 25% |
| Clobetasol Propionate .5 mg/g 21922-0017-04 | Encube | 1 tube | $0.129 | AB | Availability likely | save 25% |
| clobetasol propionate .5 mg/g 43386-0096-60 | Lupin | 1 tube | $0.129 | AB | Availability likely | save 25% |
| Clobetasol Propionate .5 mg/g 51672-1259-01 | Sun | 1 tube | $0.129 | AB | Availability likely | save 25% |
| Clobetasol Propionate .5 mg/g 59651-0732-14 | Aurobindo | 1 tube | $0.129 | AB | Availability likely | save 25% |
| Clobetasol Propionate .5 mg/g 62332-0465-15 | Alembic | 1 tube | $0.129 | AB | Availability likely | save 25% |
| Clobetasol Propionate .5 mg/g 70700-0106-15 | Xiromed, | 15 g | $0.129 | AB | Availability likely | save 25% |
| Clobetasol Propionate .5 mg/g 72603-0855-01 | NorthStar | 1 tube | $0.129 | AB | Availability likely | save 25% |
| Clobetasol Propionate .5 mg/g 69238-1532-03 | Amneal | 1 tube | $0.168 | AB1 | Availability likely | save 2% |
| Clobetasol Propionate ANDA .5 mg/gthis 33342-0506-30 | Macleods | 1 tube | $0.171 | AB | Availability likely | — |
| Clobetasol Propionate .5 mg/g 51672-1258-01 | Sun | 1 tube | $0.188 | AB1 | Availability likely | +10% |
| Clobetasol Propionate .5 mg/g 70700-0109-15 | Xiromed, | 1 tube | $0.188 | AB1 | Availability likely | +10% |
| Clobetasol Propionate .5 mg/g 62332-0547-15 | Alembic | 1 tube | $0.188 | AB1 | Availability likely | +10% |
| Clobetasol Propionate .5 mg/g 13668-0569-01 | Torrent | 15 g | $0.188 | AB1 | Availability likely | +10% |
| Clobetasol Propionate .5 mg/g 00168-0163-15 | E. | 15 g | $0.188 | AB1 | Availability likely | +10% |
| Clobetasol Propionate .5 mg/g 68180-0956-01 | Lupin | 1 tube | $0.188 | AB1 | Availability likely | +10% |
| Clobetasol Propionate .5 mg/g 68462-0529-17 | Glenmark | 1 tube | $0.224 | — | FDA listed | +31% |
| Clobetasol Propionate .5 mg/g 00168-0162-15 | E. | 15 g | $0.295 | AB | FDA listed | +73% |
| Clobetasol Propionate .5 mg/g 68462-0530-17 | Glenmark | 1 tube | $0.329 | — | FDA listed | +93% |
| Clobetasol Propionate .5 mg/g 70710-1401-01 | Zydus | 1 tube | $0.329 | AB | FDA listed | +93% |
| Clobetasol Propionate .5 mg/g 16714-0782-01 | Northstar | 1 tube | $0.329 | — | Discontinued | +93% |
| Clobetasol Propionate (emollient) .5 mg/g 00168-0301-15 | E. | 1 tube | $0.590 | AB2 | Availability likely | +245% |
| Clobetasol Propionate .5 mg/g 51672-1297-01 | Sun | 1 tube | $0.597 | AB2 | Availability likely | +249% |
| Clobetasol Propionate (emollient) .5 mg/g 83148-0064-15 | The | 1 tube | $0.597 | AB2 | Availability likely | +249% |
| Clobetasol Propionate .5 mg/g 00168-0293-15 | E. | 15 g | $0.666 | AB | FDA listed | +289% |
| Clobetasol Propionate .5 mg/g 45802-0925-14 | Padagis | 1 tube | $0.710 | AB | Availability likely | +315% |
| Clobetasol Propionate .5 mg/g 51672-1294-01 | Sun | 1 tube | $0.710 | AB | Availability likely | +315% |
| clobetasol propionate .5 mg/g 40032-0096-60 | Novel | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 42291-0077-15 | AvKARE | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 46708-0465-15 | Alembic | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 50090-5488-00 | A-S | 1 tube | — | — | FDA listed | — |
| Clobetasol Propionate .5 mg/g 50090-6402-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 50090-6731-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 50090-8001-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 63629-2455-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 63629-2456-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 63629-2457-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 63629-2458-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 68071-3922-05 | NuCare | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 68788-7963-01 | Preferred | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 70771-1209-01 | Zydus | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 71335-2837-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 71335-2851-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 71335-2859-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 71335-2860-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 72162-1273-02 | Bryant | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 50090-0549-00 | A-S | 1 tube | — | AB1 | FDA listed | — |
| Clobetasol Propionate .5 mg/g 50090-5079-00 | A-S | 1 tube | — | AB1 | FDA listed | — |
| Clobetasol Propionate .5 mg/g 50090-6717-00 | A-S | 1 tube | — | AB1 | FDA listed | — |
| Clobetasol Propionate .5 mg/g 63629-8637-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 63629-8638-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 63629-2331-01 | Bryant | 1 tube | — | AB1 | FDA listed | — |
| Clobetasol Propionate .5 mg/g 63629-2332-01 | Bryant | 1 tube | — | AB1 | FDA listed | — |
| Clobetasol Propionate .5 mg/g 46708-0547-15 | Alembic | 1 tube | — | AB1 | FDA listed | — |
| Clobetasol Propionate .5 mg/g 82804-0083-30 | Proficient | 30 g | — | AB1 | FDA listed | — |
| Clobetasol Propionate .5 mg/g 72162-1438-02 | Bryant | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 72162-1961-02 | Bryant | 1 tube | — | AB1 | FDA listed | — |
| Clobetasol Propionate (emollient) .5 mg/g 72162-2628-02 | Bryant | 1 tube | — | AB2 | FDA listed | — |
| Clobetasol Propionate .5 mg/g 72189-0262-30 | DIRECT | 30 g | — | AB1 | FDA listed | — |
| Clobetasol Propionate .5 mg/g 63629-2329-01 | Bryant | 60 g | — | AB1 | FDA listed | — |
| Clobetasol Propionate .5 mg/g 63629-2330-01 | Bryant | 1 tube | — | AB1 | FDA listed | — |
| Clobetasol Propionate .5 mg/g 63629-8639-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 42291-0076-15 | AvKARE | 1 tube | — | AB1 | FDA listed | — |
Where does this data come from?
⏳ 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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 33342-0506-15 | 1 TUBE in 1 CARTON (33342-506-15) / 15 g in 1 TUBE | $0.1291 / g | $1.94 | 2023-12-28 | Active |
| 33342-0506-30 You're viewing this | 1 TUBE in 1 CARTON (33342-506-30) / 30 g in 1 TUBE | $0.1710 / g | $5.13 | 2023-12-28 | Active |
| 33342-0506-45 | 1 TUBE in 1 CARTON (33342-506-45) / 45 g in 1 TUBE | $0.1183 / g | $5.32 | 2023-12-28 | Active |
| 33342-0506-60 | 1 TUBE in 1 CARTON (33342-506-60) / 60 g in 1 TUBE | $0.1124 / g | $6.74 | 2023-12-28 | Active |
Per g, this pack runs about 52% above the cheapest pack (NDC 33342-0506-60, $0.1124 vs $0.1710 NADAC).
This pack accounts for about 18% of this product's recent Medicaid fills; the largest share goes to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 33342-0506-30?
What NDC number is used to bill for this package of Clobetasol Propionate ANDA .5 mg/g Ointment?
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.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS & USAGE Clobetasol propionate ointment is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended.
As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
⏱️ Dosage and Administration ▾
DOSAGE & ADMINISTRATION: Apply a thin layer of clobetasol propionate ointment USP, to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE). Clobetasol propionate ointment USP, is super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved.
If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Clobetasol propionate ointment USP, should not be used with occlusive dressings. Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with clobetasol propionate ointment safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
⛔ Contraindications ▾
CONTRAINDICATIONS Clobetasol propionate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In controlled clinical trials, the most frequent adverse events reported for clobetasol propionate ointment were burning sensation, irritation, and itching in 0.5% of treated patients. Less frequent adverse reactions were stinging, cracking, erythema, folliculitis, numbness of fingers, skin atrophy, and telangiectasia. Cushing's syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations.
The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.
🤰 Pregnancy ▾
Pregnancy: Teratogenic Effects: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals. Clobetasol propionate has not been tested for teratogenicity when applied topically; however, it is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and mouse.
Clobetasol propionate has greater teratogenic potential than steroids that are less potent. Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested down to 0.03 mg/kg. These doses are approximately 1.4 and 0.04 times, respectively, the human topical dose of clobetasol propionate ointment.
Abnormalities seen included cleft palate and skeletal abnormalities. In rabbits, clobetasol propionate was teratogenic at doses of 3 and 10 mcg/kg. These doses are approximately 0.02 and 0.05 times, respectively, the human topical dose of clobetasol propionate ointment.
Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities. There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. Clobetasol propionate ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric Use: Safety and effectiveness of clobetasol propionate ointment in pediatric patients have not been established. Use in pediatric patients under 12 years of age is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids.
They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids.
Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
🧓 Geriatric Use ▾
Geriatric Use: A limited number of patients at or above 65 years of age have been treated with clobetasol propionate ointment (n = 101) in US and non-US clinical trials. While the number of patients is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients. Based on available data, no adjustment of dosage of clobetasol propionate ointment in geriatric patients is warranted.
🆘 Overdosage ▾
OVERDOSAGE: Topically applied clobetasol propionate ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins.
It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier.
Occlusive dressing with hydrocortisone for up to 24 hours has not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
Studies performed with clobetasol propionate ointment indicate that they are in the super-high range of potency as compared with other topical corticosteroids.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Clobetasol propionate ointment USP, 0.05% is supplied in 15 g tube NDC 33342-506-15 30 g tube NDC 33342-506-30 45 g tube NDC 33342-506-45 60 g tube NDC 33342-506-60 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Do not refrigerate. Manufactured for : Macleods Pharma USA, Inc.
Princeton, NJ 08540 Manufactured by: Macleods Pharmaceuticals Ltd. At Oxalis Labs, Baddi, Himachal Pradesh, INDIA Revised: January 2024
📋 Description ▾
DESCRIPTION Clobetasol propionate ointment USP, contain the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β, 16 β)-21-chloro-9-fluoro-11-hydroxy-16-methyt-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula: Clobetasol propionate has the empirical formula C 25 H 32 CIF0 5 and a molecular weight of 467.
It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate ointment USP, clobetasol propionate 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum. str
💬 Information for Patients ▾
Information for Patients: Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
This medication should not be used for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions to the physician.