Clobetasol Propionate .5 mg/g Ointment — NDC 68071-3922-5 (Billing 68071-3922-05)
This is a package of Clobetasol Propionate .5 mg/g Ointment from NuCare Pharmaceuticals, Inc., marketed since Mar 2019 and currently FDA-listed. It is this product's only package size.
Other active recalls for Clobetasol Propionate (different manufacturers) — 1 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 861448
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 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
Clobetasol topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various scalp and 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). Clobetasol 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 inflamed, itchy skin and scalp conditions, including plaque psoriasis. The exact use depends on your product, such as shampoo for scalp psoriasis or spray for plaque psori...
- Usually only a short time, often 2 weeks and up to 4 weeks for some products. Stop when your skin is under control. If you see no improvement in 2 weeks, check back with your presc...
- Generally no. Most clobetasol skin products should not be used on the face, armpits or groin. Keep it out of your eyes and mouth, and follow your product's directions.
- Mild burning, stinging, itching or dryness where you apply it. Call your doctor if your skin thins, breaks out, looks infected or gets worse. Also call for signs of steroid effects...
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?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 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 | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.2669 | $4.00 / 15 g |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 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 | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 68071-3922-05 You're viewing this Main listing | 1 TUBE in 1 CARTON / 15 g in 1 TUBE | 2025-12-04 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Clobetasol Propionate .5 mg/g 00713-0656-15 | Cosette | 1 tube | $0.138 | AB | Availability likely | — |
| Clobetasol Propionate .5 mg/g 21922-0017-04 | Encube | 1 tube | $0.138 | AB | Availability likely | — |
| Clobetasol Propionate ANDA .5 mg/g 33342-0506-15 | Macleods | 1 tube | $0.138 | AB | Availability likely | — |
| clobetasol propionate .5 mg/g 43386-0096-60 | Lupin | 1 tube | $0.138 | AB | Availability likely | — |
| Clobetasol Propionate .5 mg/g 51672-1259-01 | Sun | 1 tube | $0.138 | AB | Availability likely | — |
| Clobetasol Propionate .5 mg/g 59651-0732-14 | Aurobindo | 1 tube | $0.138 | AB | Availability likely | — |
| Clobetasol Propionate .5 mg/g 62332-0465-15 | Alembic | 1 tube | $0.138 | AB | Availability likely | — |
| Clobetasol Propionate .5 mg/g 70700-0106-15 | Xiromed, | 15 g | $0.138 | AB | Availability likely | — |
| Clobetasol Propionate .5 mg/g 72603-0855-01 | NorthStar | 1 tube | $0.138 | AB | Availability likely | — |
| Clobetasol Propionate .5 mg/g 69238-1532-03 | Amneal | 1 tube | $0.167 | AB1 | Availability likely | — |
| Clobetasol Propionate .5 mg/g 51672-1258-01 | Sun | 1 tube | $0.193 | AB1 | Availability likely | — |
| Clobetasol Propionate .5 mg/g 70700-0109-15 | Xiromed, | 1 tube | $0.193 | AB1 | Availability likely | — |
| Clobetasol Propionate .5 mg/g 62332-0547-15 | Alembic | 1 tube | $0.193 | AB1 | Availability likely | — |
| Clobetasol Propionate .5 mg/g 13668-0569-01 | Torrent | 15 g | $0.193 | AB1 | Availability likely | — |
| Clobetasol Propionate .5 mg/g 00168-0163-15 | E. | 15 g | $0.193 | AB1 | Availability likely | — |
| Clobetasol Propionate .5 mg/g 68180-0956-01 | Lupin | 1 tube | $0.193 | AB1 | Availability likely | — |
| Clobetasol Propionate .5 mg/g 68462-0529-17 | Glenmark | 1 tube | $0.224 | — | FDA listed | — |
| Clobetasol Propionate .5 mg/g 00168-0162-15 | E. | 15 g | $0.295 | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 68462-0530-17 | Glenmark | 1 tube | $0.329 | — | FDA listed | — |
| Clobetasol Propionate .5 mg/g 70710-1401-01 | Zydus | 1 tube | $0.329 | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 16714-0782-01 | Northstar | 1 tube | $0.329 | — | Discontinued | — |
| Clobetasol Propionate (emollient) .5 mg/g 00168-0301-15 | E. | 1 tube | $0.590 | AB2 | Discontinued | — |
| Clobetasol Propionate .5 mg/g 51672-1297-01 | Sun | 1 tube | $0.601 | AB2 | Availability likely | — |
| Clobetasol Propionate (emollient) .5 mg/g 83148-0064-15 | The | 1 tube | $0.601 | AB2 | Availability likely | — |
| Clobetasol Propionate .5 mg/g 00168-0293-15 | E. | 15 g | $0.666 | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 45802-0925-14 | Padagis | 1 tube | $0.862 | AB | Availability likely | — |
| Clobetasol Propionate .5 mg/g 51672-1294-01 | Sun | 1 tube | $0.862 | AB | Availability likely | — |
| 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/gthis 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?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
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 Sep 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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 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
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Clobetasol Propionate Ointment USP, 0.05% 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 per 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 AND ADMINISTRATION Apply a thin layer of clobetasol propionate ointment to the affected skin areas twice daily and rub in gently and completely. (See INDICATIONS AND USAGE ). Clobetasol propionate ointment is super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 g per 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 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. To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🆘 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 dressings 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 this is 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 tamper-evident tubes as follows: Strength NDC Number 15 g (NDC 68071-3922-5) Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals limited (Derma Division), Karakhadi, Vadodara 391450, India.
Mfg. License No.: G/25/2216 Revised: 03/2025
📋 Description ▾
DESCRIPTION Clobetasol Propionate Ointment USP, 0.05% contains 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. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water.
Chemically, it is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula: Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum. Structure
⚠️ Precautions ▾
PRECAUTIONS General: Clobetasol propionate ointment should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal from treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on therapy.
Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. Patients receiving super-potent corticosteroids should not be treated for more than 2 weeks at a time, and only small areas should be treated at any one time due to the increased risk of HPA suppression.
Clobetasol propionate ointment produced HPA axis suppression when used at doses as low as 2 grams per day for 1 week in patients with eczema. 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 corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.
Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur that require supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see PRECAUTIONS: Pediatric Use ).
If irritation develops, clobetasol propionate should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.
If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of clobetasol propionate should be discontinued until the infection has been adequately controlled. 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. Laboratory Tests: The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH stimulation test A.M. plasma cortisol test Urinary free cortisol test.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate. Studies in the rat following subcutaneous administration at dosage levels up to 50 mcg/kg per day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose. Clobetasol propionate was non-mutagenic in three different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test.
Pregnancy: Teratogenic Effects : Pregnancy Category C. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corti… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL PRINCIPAL DISPLAY PANEL 15 G CARTON pdp
Medicare Part D spend CMS · PART D · 2026 (Q1)
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |