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Clobetasol Propionate Cream USP, 0.05% .5 mg/g Cream, 30 g — NDC 21922-0016-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Clobetasol Propionate Cream USP, 0.05% .5 mg/g Cream, 30 g — NDC 21922-016-05 (Billing 21922-0016-05)

by Encube Ethicals, Inc. · 30 g in 1 TUBE

This is a package of 30 g of Clobetasol Propionate Cream USP, 0.05% .5 mg/g Cream from Encube Ethicals, Inc., marketed since Oct 2020 and currently FDA-listed; retail pharmacies pay about $0.1668 per g (NADAC).

NDC 21922-0016-05
🏷️ FDA NDC (as labeled) 21922-016-05 billing pads the product segment with a zero
This package
Contains30 g Cost per g$0.1668 NADAC Per package$5.00 / 30 g Pack sizes4 compare ↓
Also priced by: Medicaid pays $0.4986/unit — full pricing hub ↓
Product page 21922-0016-07 Also comes in: 15 g 21922-016-04 45 g 21922-016-06 60 g 21922-016-07
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 21922-016-05
Product NDC 21922-016
11-digit billing NDC 21922001605
NCPDP billing unit GM — per gram (weight)
RxCUI 861495
UNII 779619577M
Application # ANDA212982
SPL Set ID bcb76b4b-194d-4cb3-b3ed-26b911df1a11
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-10-01
Route TOPICAL
Dosage form CREAM
Substance CLOBETASOL PROPIONATE
TE code (Orange Book) AB1 · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90550025103705
GCN Seq No 007634
GCN 32140
HICL code 003327
Ingredient (HICL) Clobetasol Propionate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5P
Therapeutic class — specific (HIC3) Topical Anti-Inflammatory Steroidal
AHFS code 84:06.08.00
AHFS class Corticosteroids (Skin, Mucous Membrane)
FDB label name CLOBETASOL 0.05% CREAM
FDB brand name Clobetasol Propionate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007634
  • GCN: 32140
  • GPI-14 (Medi-Span): 90550025103705
  • HICL (First Databank): 003327
  • AHFS class code: 84:06.08.00
  • RxCUI (RxNorm): 861495
Why two NDCs? The FDA registers this code as 21922-016-05 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 21922-0016-05. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, very potent (group IV), Corticosteroids, plain
How it works Corticosteroid Hormone Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name CLOBETASOL 0.05% CREAM Ingredient Clobetasol Propionate
📗 Our plain-language guide HelloPharmacist
  • 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...
📖 Read our full Clobetasol guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer gPer package
Retail pharmacies payNADAC · weekly $0.167 $5.00 / 30 g
Medicaid paysCMS SDUD · 12 mo $0.4986 $14.96 / 30 g
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per g) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.345 $0.167
▼ Down 47% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
21922-0016-04 21922-016-04 15 g in 1 TUBE $0.1930 / g $2.90 2020-10-01 — Active
21922-0016-05 You're viewing this 30 g in 1 TUBE $0.1668 / g $5.00 2020-10-01 — Active
21922-0016-06 21922-016-06 45 g in 1 TUBE $0.1216 / g $5.47 2020-10-01 — Active
21922-0016-07 21922-016-07 Main listing 60 g in 1 TUBE $0.1404 / g $8.42 2020-10-01 — Active

You're viewing one of 4 pack sizes for this product.

Per g, this pack runs about 37% above the cheapest pack (45 g, $0.1216 vs $0.1668 NADAC).

This pack accounts for about 26% of this product's recent Medicaid fills; the largest share goes to the 60 g pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 30 g — 30 g in 1 tube.
How does this package differ from NDC 21922-0016-04?
Both are Clobetasol Propionate Cream USP, 0.05% .5 mg/g Cream — the drug itself is identical. This page's package is the 30 g one, while NDC 21922-0016-04 is the 15 g package. Per-g NADAC also differs: $0.1668 here vs $0.1930 for the 15 g pack.
What NDC number is used to bill for this package of Clobetasol Propionate Cream USP, 0.05% .5 mg/g Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% .5 mg/gthis 21922-0016-05 Encube 30 g $0.167 AB1 Availability likely —
Clobetasol Propionate .5 mg/g 69238-1532-03 Amneal 1 tube $0.167 AB1 Availability likely —
Clobetasol Propionate .5 mg/g 00168-0163-15 E. 15 g $0.193 AB1 Availability likely +16%
Clobetasol Propionate .5 mg/g 13668-0569-01 Torrent 15 g $0.193 AB1 Availability likely +16%
Clobetasol Propionate .5 mg/g 51672-1258-01 Sun 1 tube $0.193 AB1 Availability likely +16%
Clobetasol Propionate .5 mg/g 62332-0547-15 Alembic 1 tube $0.193 AB1 Availability likely +16%
Clobetasol Propionate .5 mg/g 68180-0956-01 Lupin 1 tube $0.193 AB1 Availability likely +16%
Clobetasol Propionate .5 mg/g 70700-0109-15 Xiromed, 1 tube $0.193 AB1 Availability likely +16%
Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% .5 mg/g 72603-0323-01 Northstar 15 g $0.193 AB1 Availability likely +16%
Clobetasol Propionate .5 mg/g 68462-0529-17 Glenmark 1 tube $0.224 — FDA listed +34%
Clobetasol Propionate .5 mg/g 42291-0076-15 AvKARE 1 tube — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 46708-0547-15 Alembic 1 tube — AB1 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 Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% .5 mg/g 50090-5979-00 A-S 30 g — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 50090-6717-00 A-S 1 tube — AB1 FDA listed —
Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% .5 mg/g 50090-7392-00 A-S 15 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 63629-2331-01 Bryant 1 tube — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 63629-2332-01 Bryant 1 tube — AB1 FDA listed —
Clobetasol Propionate Cream 0.05% Clobetasol Propionate Cream 0.05% .5 mg/g 68788-4001-06 Preferred 60 g — AB1 FDA listed —
Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% .5 mg/g 70518-4374-00 REMEDYREPACK 30 g — AB1 FDA listed —
Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% .5 mg/g 71335-2821-01 Bryant 60 g — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 72162-1961-02 Bryant 1 tube — AB1 FDA listed —
Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% .5 mg/g 72162-2300-02 Bryant 15 g — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 72189-0262-30 DIRECT 30 g — AB1 FDA listed —
Clobetasol Propionate .5 mg/g 82804-0083-30 Proficient 30 g — AB1 FDA listed —
Clobetasol Propionate Cream, 0.05% Clobetasol Propionate Cream, 0.05% .5 mg/g 82804-0133-30 Proficient 30 g — AB1 FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2020
On the market since
Oct 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerEncube Ethicals, Inc.
Application holderENCUBE ETHICALS PRIVATE LTD
FDA applicationANDA212982 (ANDA)
Labeler code21922
First marketedOct 2020
Product typeHuman Prescription Drug
Portfolio77 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 100 words ▾

INDICATIONS AND USAGE: Clobetasol propionate cream USP, 0.05% is super-high potency corticosteroid formulation 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 133 words ▾

DOSAGE AND ADMINISTRATION: Apply a thin layer of clobetasol propionate cream to the affected skin areas twice daily and rub in gently and completely (See INDICATIONS AND USAGE). Clobetasol propionate cream 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 cream 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 cream, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

⛔ Contraindications 24 words ▾

CONTRAINDICATIONS: Clobetasol propionate cream USP, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

🤒 Adverse Reactions 133 words ▾

ADVERSE REACTIONS: In controlled clinical trials, the most frequent adverse reactions reported for clobetasol propionate cream were burning and stinging sensation in 1% of treated patients. Less frequent adverse reactions were itching, skin atrophy, and cracking and fissuring of the skin. 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 Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 212 words ▾

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 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 cream.

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 cream.

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 cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 148 words ▾

Pediatric Use: Safety and effectiveness of clobetasol propionate cream 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 78 words ▾

Geriatric Use: A limited number of patients at or above 65 years of age have been treated with clobetasol propionate cream (n = 231) 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 cream in geriatric patients is warranted.

🆘 Overdosage 18 words ▾

OVERDOSAGE: Topically applied clobetasol propionate cream can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

🧬 Clinical Pharmacology 180 words ▾

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 cream indicate that it is in the super-high range of potency as compared with other topical corticosteroids.

📦 How Supplied / Storage and Handling 108 words ▾

HOW SUPPLIED: Clobetasol Propionate Cream USP, 0.05% is supplied in 15 g tube (NDC 21922-016-04) 30 g tube (NDC 21922-016-05) 45 g tube (NDC 21922-016-06) 60 g tube (NDC 21922-016-07) Store cream between 15° and 30°C (59°-86°F). Clobetasol propionate cream should not refrigerated. Made in Italy, formulated in India.

Manufactured by: Encube Ethicals Pvt. Ltd. Plot No.

C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. OR Manufacture by: Encube Ethicals Pvt. Ltd.

Plot No. 113, Smart Industrial Park, Pithampur, District: Dhar – 454 774, Madhya Pradesh, India. Distributed by: Encube Ethicals, Inc.

200 Meredith Drive, Suite 202 Durham, NC 27713 USA Rev: 12/23

📋 Description 115 words ▾

DESCRIPTION: Clobetasol Propionate Cream USP 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. Chemically, clobetasol propionate is (11β, 16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula: Clobetasol propionate has the molecular formula C 25 H 32 ClFO 5 and a molecular weight of 467.

It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream USP, 0.05% contains clobetasol propionate 0.5 mg/g in a cream base of propylene glycol, mono- and di-glycerides, cetostearyl alcohol, stearoyl macrogolglycerides, white wax, chlorocresol, sodium citrate, anhydrous citric acid, and purified water. structure.jpg

💬 Information for Patients 91 words ▾

Information for Patients: 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. This medication should not be used for any disorder other than that for which it was prescribed.

3. The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician. 4.

Patients should report any signs of local adverse reactions to the physician.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General: Clobetasol propionate cream USP, 0.05% 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 cream produced HPA axis suppression when used at doses as low as 2 g/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 cream should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a 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 cream should be discontinued until the infection has been adequately controlled. Information for Patients: 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. This medication should not be used for any disorder other than that for which it was prescribed. 3.

The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician. 4. 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/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 nonmutagenic in 3 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.… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 67 words ▾

Nursing Mothers: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when clobetasol propionate cream is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 86 words ▾

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/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 nonmutagenic in 3 different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test.

📄 Package Label / Principal Display Panel ~2 min read ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL-Carton NDC 21922-016-04 Clobetasol Propionate Cream USP, 0.05% For dermatologic use only. Not for ophthalmic use. Rx only 15 grams Manufactured by: Encube Ethicals Pvt.

Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India.

Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202, Durham, NC 27713, USA NDC 21922-016-05 Clobetasol Propionate Cream USP, 0.05% For dermatologic use only. Not for ophthalmic use.

Rx only 30 grams Manufactured by: Encube Ethicals Pvt. Ltd. Plot No.

C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202, Durham, NC 27713, USA NDC 21922-016-06 Clobetasol Propionate Cream USP, 0.05% For dermatologic use only.

Not for ophthalmic use. Rx only 45 grams Manufactured by: Encube Ethicals Pvt. Ltd.

Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc.

200 Meredith Drive, Suite 202, Durham, NC 27713, USA NDC 21922-016-07 Clobetasol Propionate Cream USP, 0.05% For dermatologic use only. Not for ophthalmic use. Rx only 60 grams Manufactured by: Encube Ethicals Pvt.

Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India.

Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202, Durham, NC 27713, USA NDC 21922-016-04 Clobetasol Propionate Cream USP, 0.05% For dermatologic use only. Not for ophthalmic use.

Rx only 15 grams Manufacture by: Encube Ethicals Pvt. Ltd. Plot No.

113, Smart Industrial Park, Pithampur, District: Dhar – 454 774, Madhya Pradesh, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202, Durham, NC 27713, USA NDC 21922-016-05 Clobetasol Propionate Cream USP, 0.05% For dermatologic use only.

Not for ophthalmic use. Rx only 30 grams Manufacture by: Encube Ethicals Pvt. Ltd.

Plot No. 113, Smart Industrial Park, Pithampur, District: Dhar – 454 774, Madhya Pradesh, India. Distributed by: Encube Ethicals, Inc.

200 Meredith Drive, Suite 202, Durham, NC 27713, USA NDC 21922-016-06 Clobetasol Propionate Cream USP, 0.05% For dermatologic use only. Not for ophthalmic use. Rx only 45 grams Manufacture by: Encube Ethicals Pvt.

Ltd. Plot No. 113, Smart Industrial Park, Pithampur, District: Dhar – 454 774, Madhya Pradesh, India.

Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202, Durham, NC 27713, USA NDC 21922-016-07 Clobetasol Propionate Cream USP, 0.05% For dermatologic use only. Not for ophthalmic use.

Rx only 60 grams Manufacture by: Encube Ethicals Pvt. Ltd. Plot No.

113, Smart Industrial Park, Pithampur, District: Dhar – 454 774, Madhya Pradesh, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202, Durham, NC 27713, USA clobetasol-carton-15-g clobetasol-carton-30-g clobetasol-carton-45-g clobetasol-carton-60-g 15 g c 30 g c 45 g c 60 g c

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
60.7K
Units reimbursed last 4 qtrs
2.3M
Gross reimbursed last 4 qtrs
$1.14M
Avg / prescription
$18.74
Avg / unit
$0.4986
Latest quarter Q1 2026
13.4KRx
Medicaid pays / g
$0.4986
gross reimbursed
vs
NADAC / g
$0.1668
acquisition cost
=
Spread
+$0.3318
+199% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
44% FFS 56% MCO
Fee-for-service · 26,942 Rx Managed care · 33,713 Rx
State Medicaid map
Alaska: 9,240 units · 1,261 per 100k residents AK Maine: 9,030 units · 647 per 100k residents ME Washington: 60,330 units · 772 per 100k residents WA Idaho: 15,330 units · 781 per 100k residents ID Montana: 11,025 units · 974 per 100k residents MT North Dakota: 360 units · 46.0 per 100k residents ND Minnesota: 47,520 units · 828 per 100k residents MN Wisconsin: 56,670 units · 959 per 100k residents WI Michigan: 115,620 units · 1,152 per 100k residents MI New York: 167,640 units · 857 per 100k residents NY Vermont: 6,630 units · 1,025 per 100k residents VT New Hampshire: 7,050 units · 503 per 100k residents NH Oregon: 37,410 units · 884 per 100k residents OR Nevada: 28,815 units · 902 per 100k residents NV Wyoming: 420 units · 71.9 per 100k residents WY South Dakota: 4,245 units · 462 per 100k residents SD Iowa: 25,350 units · 790 per 100k residents IA Illinois: 91,725 units · 731 per 100k residents IL Indiana: 36,315 units · 529 per 100k residents IN Ohio: 134,744 units · 1,143 per 100k residents OH Pennsylvania: 71,055 units · 548 per 100k residents PA New Jersey: 7,455 units · 80.2 per 100k residents NJ Massachusetts: 22,260 units · 318 per 100k residents MA California: 416,171 units · 1,068 per 100k residents CA Utah: 20,219 units · 592 per 100k residents UT Colorado: 39,240 units · 668 per 100k residents CO Nebraska: 9,135 units · 462 per 100k residents NE Missouri: 53,010 units · 856 per 100k residents MO Kentucky: 77,941 units · 1,722 per 100k residents KY West Virginia: 29,460 units · 1,664 per 100k residents WV Virginia: 53,625 units · 615 per 100k residents VA Maryland: 18,225 units · 295 per 100k residents MD Connecticut: 43,200 units · 1,194 per 100k residents CT Rhode Island: 5,670 units · 518 per 100k residents RI Arizona: 80,190 units · 1,079 per 100k residents AZ New Mexico: 11,340 units · 536 per 100k residents NM Kansas: 5,925 units · 202 per 100k residents KS Arkansas: 8,835 units · 288 per 100k residents AR Tennessee: 51,105 units · 717 per 100k residents TN North Carolina: 84,960 units · 784 per 100k residents NC South Carolina: 11,595 units · 216 per 100k residents SC Delaware: 1,950 units · 189 per 100k residents DE Oklahoma: 32,310 units · 797 per 100k residents OK Louisiana: 63,735 units · 1,393 per 100k residents LA Mississippi: 10,290 units · 350 per 100k residents MS Alabama: 11,220 units · 220 per 100k residents AL Georgia: 24,990 units · 227 per 100k residents GA D.C.: 2,220 units · 327 per 100k residents DC Hawaii: 13,290 units · 926 per 100k residents HI Texas: 47,085 units · 154 per 100k residents TX Florida: 86,115 units · 381 per 100k residents FL
Units reimbursed · per 100k residents
46.01,722
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Kentucky 1,722 /100k
2 West Virginia 1,664 /100k
3 Louisiana 1,393 /100k
4 Alaska 1,261 /100k
5 Connecticut 1,194 /100k
6 Michigan 1,152 /100k
7 Ohio 1,143 /100k
8 Arizona 1,079 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
60 g21922-0016-07 93,828 Rx · $2,268,275
30 g this page21922-0016-05 60,655 Rx · $1,136,523
15 g21922-0016-04 54,979 Rx · $738,163
45 g21922-0016-06 25,864 Rx · $547,467
Drug total (last 4 qtrs): 235,326 Rx · 10,654,607 units · $4,690,427 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
← 21922-0015-40 · Encube 21922-0017-04 · Encube →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.