Mechanism of actionCorticosteroid Hormone Receptor Agonists
DEA scheduleNon-controlled
Marketing categoryANDA
Marketing statusOn market
FDA listing statusListed (active directory)
Marketing start2022-03-14
RouteTOPICAL
Dosage formSOLUTION
SubstanceCLOBETASOL PROPIONATE
GPI-1490550025102005
GCN Seq No015349
GCN15891
HICL code003327
Ingredient (HICL)Clobetasol Propionate
HIC1 codeQ
Therapeutic class — broad (HIC1)Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 codeQ5
Therapeutic class — intermediate (HIC2)Agents Acting Principally On The Skin
HIC3 codeQ5P
Therapeutic class — specific (HIC3)Topical Anti-Inflammatory Steroidal
AHFS code84:06.08.00
AHFS classCorticosteroids (Skin, Mucous Membrane)
FDB label nameCLOBETASOL 0.05% SOLUTION
FDB brand nameClobetasol Propionate
Legend statusF — Federal legend — prescription drug or device
TE code (Orange Book)AT · RLD · RS
Why two NDCs?
The FDA registers this code as 70752-153-20 — 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 → 70752-0153-20. 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 classCorticosteroid
Drug family (ATC)Corticosteroids, very potent (group IV), Corticosteroids, plain
How it worksCorticosteroid 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.
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.
🩺 Clinical
Label name CLOBETASOL 0.05% SOLUTIONIngredient Clobetasol Propionate
📗 Our plain-language guide HelloPharmacist
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...
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.
💬 Questions about clobetasol propionate?
Ask a licensed pharmacist directly — free, answered by our team.
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.
A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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.
💲 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 mL
Per package
Retail pharmacies payNADAC · weekly
$0.244
$6.09 / 25 ml
Medicaid paysCMS SDUD · 12 mo
$0.5701
$14.25 / 25 ml
Medicare drug plans payPart D · Q2 2026
$0.3488
$8.72 / 25 ml
NADAC price history (per mL) — tap or hover for the price & month
▼ Down 49% over the last 12 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.
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
🏛️
2022
On the market since
Mar 2022
📍
2026
Currently FDA-listed
4 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.
🗺️ 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 70752-0153-20, 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 – Q4 2025 · 4 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
203
Units reimbursed last 4 qtrs
7.5K
Gross reimbursed last 4 qtrs
$4.3K
Avg / prescription
$20.95
Avg / unit
$0.5701
Latest quarter Q4 2025
53Rx
Medicaid pays / mL
$0.5701
gross reimbursed
vs
NADAC / mL
$0.2437
acquisition cost
=
Spread
+$0.3264
+134% vs cost
What Medicaid paid per mL (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 ⓘ
77% FFS23% MCO
Fee-for-service · 156 Rx Managed care · 47 Rx
State Medicaid map
Units reimbursed · per 100k residents
9.415.3
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
1New Jersey15.3 /100k
2New York12.2 /100k
3California9.4 /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.
Drug total (last 4 qtrs): 1,168 Rx · 58,324 units · $23,259 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Clobetasol Propionate — the program that covers self-administered drugs. 22 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Clobetasol Propionate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$28.79M
Claims incl. refills
813.5K
Beneficiaries
629K
Spend / beneficiary
$45.78
Spend / claim
$35.39
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Clobetasol Propionate — the ingredient across all brands.
Top reported reactions
Pruritus925
Rash667
Psoriasis550
Fatigue512
Headache493
Diarrhoea439
Nausea439
Age at onset
Neonate3
Infant4
Child79
Adolescent86
Adult1,895
Elderly1,258
Reporter sex
Male · 36%
Female · 64%
Unknown · 0%
Serious outcomes
Hospitalization2,013
Life-threatening245
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
1 BOTTLE in 1 CARTON (70752-153-04) / 50 mL in 1 BOTTLE
$0.1345 / mL
$6.73
2022-03-14
Active
70752-0153-20 You're viewing this
1 BOTTLE in 1 CARTON (70752-153-20) / 25 mL in 1 BOTTLE
$0.2437 / mL
$6.09
2022-03-14
Active
Per mL, this pack runs about 81% above the cheapest pack (NDC 70752-0153-04, $0.1345 vs $0.2437 NADAC).
This pack accounts for about 17% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 70752-0153-20?
NDC 70752-0153-20 is listed by the FDA — 1 bottle in 1 carton / 25 ml in 1 bottle.
What NDC number is used to bill for this package of CLOBETASOL PROPIONATE .5 mg/mL Solution?
Bill NDC 70752-0153-20 — the 11-digit billing format is 70752015320. 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.
📄 Full prescribing information FDA SPL
The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
INDICATIONS AND USAGE Clobetasol propionate topical solution is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.
⏱️Dosage and Administration101 words▾
DOSAGE AND ADMINISTRATION Clobetasol propionate topical solution should be applied to the affected scalp areas twice daily, once in the morning and once at night. Clobetasol propionate topical solution is potent; therefore, treatment must be limited to 2 consecutive weeks and amounts greater than 50 mL/week should not be used. Clobetasol propionate topical solution is not to 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 topical solution, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
⛔Contraindications32 words▾
CONTRAINDICATIONS Clobetasol propionate topical solution is contraindicated in patients with primary infections of the scalp, or in patients who are hypersensitive to clobetasol propionate, other corticosteroids, or any ingredient in this preparation.
🤒Adverse Reactions215 words▾
ADVERSE REACTIONS Clobetasol propionate topical solution is generally well tolerated when used for 2-week treatment periods. The most frequent adverse events reported for clobetasol propionate topical solution have been local and have included burning and/or stinging sensation, which occurred in 29 of 294 patients; scalp pustules, which occurred in 3 of 294 patients; and tingling and folliculitis, each of which occurred in 2 of 294 patients. Less frequent adverse events were itching and tightness of the scalp, dermatitis, tenderness, headache, hair loss, and eye irritation, each of which occurred in 1 of 294 patients.
The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions are listed in an approximately decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioraldermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing syndrome, hyperglycemia, and glucosuria in some patients.
In rare instances, treatment (or withdrawal of treatment) of psoriasis with corticosteroids is thought to have exacerbated the disease or provoked the pustular form of the disease, so careful patient supervision is recommended. To report SUSPECTED ADVERSE REACTIONS, contact Quagen Pharmaceuticals LLC at 1-888-344-9603 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🆘Overdosage20 words▾
OVERDOSAGE Topically applied clobetasol propionate topical solution can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).
🧬Clinical Pharmacology~1 min read▾
CLINICAL PHARMACOLOGY The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects. Topical corticosteroids such as clobetasol propionate are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions.
However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. Clobetasol propionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids, including clobetasol propionate, is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings (see DOSAGE AND ADMINISTRATION ).
As with all topical corticosteroids, clobetasol propionate can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (see DOSAGE AND ADMINISTRATION ).
Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similarly 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, including clobetasol propionate and its metabolites, are also excreted into the bile. Following repeated nonocclusive application in the treatment of scalp psoriasis, there is some evidence that clobetasol propionate topical solution has the potential to depress plasma cortisol levels in some patients. However, hypothalamic-pituitary-adrenal (HPA) axis effects produced by systemically absorbed clobetasol propionate have been shown to be transient and reversible upon completion of a 2-week course of treatment.
📦How Supplied / Storage and Handling65 words▾
HOW SUPPLIED Clobetasol Propionate Topical Solution USP, 0.05% is supplied in plastic squeeze bottles. 25 mL (NDC 70752-153-20) 50 mL (NDC 70752-153-04). 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]. Do not use near an open flame. Rx Only Manufactured by: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 52029 Rev. 03/2022
No label section mentions that — try another word, or open the full label on DailyMed below.
Glossary — plain-language definitions of medical terms used in this label:
contraindicated: Should not be used in that situation, because the risk is considered too high.
immunosuppressive: Describes something that lowers the activity of the immune system.
Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.
Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.
Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.
contact dermatitis: A skin rash caused by touching something that irritates the skin or triggers an allergy.
Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.
dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.
Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.
hyperglycemia: High blood sugar, meaning there is more glucose (sugar) in the blood than normal.
Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.
NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.
Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.
Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.
Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.
topical: Applied onto the skin, eyes, or another body surface to work mainly where it is placed.
withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.
