HomeNDC LookupIngredientsClobetasol Propionate › 13668-0569-05
Clobetasol Propionate .5 mg/g Cream, 60 g — NDC 13668-0569-05 package photo

Clobetasol Propionate .5 mg/g Cream, 60 g

by Torrent Pharmaceuticals Limited · 60 g in 1 TUBE (13668-569-05)
NDC 13668-0569-05
🏷️ FDA NDC (as labeled) 13668-569-05 billing pads the product segment with a zero
This package
Contains60 g Cost per g$0.1427 NADAC Per package$8.56 / 60 g Pack sizes4 compare ↓
Also priced by: Medicaid pays $0.3424/unit · Part D plans $0.2669/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Clobetasol Propionate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 3, 2026 — Failed content uniformity specifications. (Lupin Pharmaceuticals Inc.) · FDA recall D-0789-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 13668-569-05
Product NDC 13668-569
11-digit billing NDC 13668056905
NCPDP billing unit GM — per gram (weight)
RxCUI 861495
UNII 779619577M
UPC 0313668569018
Application # ANDA211836
SPL Set ID 6f930298-e410-4bfb-8c3f-456a1f55f4a9
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 2024-12-15
Route TOPICAL
Dosage form CREAM
Substance CLOBETASOL PROPIONATE
GPI-14 90550025103705
GPI class Clobetasol Propionate
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
TE code (Orange Book) AB1 · RLD · RS
Why two NDCs? The FDA registers this code as 13668-569-05 — 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 → 13668-0569-05. 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.

🏭 Manufacturer & labeler

LabelerTorrent Pharmaceuticals Limited
Application holderTORRENT PHARMACEUTICALS LTD
FDA applicationANDA211836 (ANDA)
Labeler code13668
First marketedDec 2024
Product typeHuman Prescription Drug
Portfolio182 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.

🩺 Clinical

Label name CLOBETASOL 0.05% CREAM Ingredient 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...
📖 Read our full Clobetasol guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Clobetasol Propionate — tap one for details:

8
Nutrient depletion considerations

Clobetasol may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

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.

💊 What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 0324G66D0E
    Glycol stearate is a waxy compound made by combining stearic acid with ethylene glycol. It acts as an emulsifier and thickener, helping keep oil and water mixed together smoothly in liquid or semi-solid medicines.
  • UNII OVV5IIJ58F
    Lanolin oil is a waxy substance derived from sheep's wool that acts as an emollient and skin-conditioning agent. It helps soften and smooth the skin while also serving as a moisturizing component in topical formulations.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • 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.
  • UNII 2P9L47VI5E
    A waxy compound made by combining polyethylene glycol with stearic acid. It acts as an emulsifier and thickener, helping blend oil and water-based ingredients and giving the medicine a smooth, stable consistency.
  • UNII CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.

13 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient 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?
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 systemPer gPer package
Retail pharmacies payNADAC · weekly $0.143 $8.56 / 60 g
Medicaid paysCMS SDUD · 12 mo $0.3424 $20.54 / 60 g
Medicare drug plans payPart D · Q2 2026 $0.2669 $16.01 / 60 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jul 2022 Feb 2024 Aug 2026 $0.455 $0.106
▼ Down 67% over the last 22 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
clobetasol propionate .5 mg/g 43386-0096-60 Lupin 1 tube $0.129 AB Availability likely save 10%
Clobetasol Propionate .5 mg/g 00713-0656-15 Cosette 1 tube $0.129 AB Availability likely save 10%
Clobetasol Propionate ANDA .5 mg/g 33342-0506-15 Macleods 1 tube $0.129 AB Availability likely save 10%
Clobetasol Propionate .5 mg/g 70700-0106-15 Xiromed, 15 g $0.129 AB Availability likely save 10%
Clobetasol Propionate .5 mg/g 59651-0732-14 Aurobindo 1 tube $0.129 AB Availability likely save 10%
Clobetasol Propionate .5 mg/g 51672-1259-01 Sun 1 tube $0.129 AB Availability likely save 10%
Clobetasol Propionate .5 mg/g 72603-0855-01 NorthStar 1 tube $0.129 AB Availability likely save 10%
Clobetasol Propionate .5 mg/g 62332-0465-15 Alembic 1 tube $0.129 AB Availability likely save 10%
Clobetasol Propionate .5 mg/gthis 13668-0569-05 Torrent 60 g $0.143 AB1 Availability likely
Clobetasol Propionate .5 mg/g 69238-1532-03 Amneal 1 tube $0.168 AB1 Availability likely +18%
Clobetasol Propionate .5 mg/g 00168-0163-15 E. 15 g $0.188 AB1 Availability likely +32%
Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% .5 mg/g 21922-0016-04 Encube 15 g $0.188 AB1 Availability likely +32%
Clobetasol Propionate .5 mg/g 51672-1258-01 Sun 1 tube $0.188 AB1 Availability likely +32%
Clobetasol Propionate .5 mg/g 62332-0547-15 Alembic 1 tube $0.188 AB1 Availability likely +32%
Clobetasol Propionate .5 mg/g 68180-0956-01 Lupin 1 tube $0.188 AB1 Availability likely +32%
Clobetasol Propionate .5 mg/g 70700-0109-15 Xiromed, 1 tube $0.188 AB1 Availability likely +32%
Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% .5 mg/g 72603-0323-01 Northstar 15 g $0.188 AB1 Availability likely +32%
Clobetasol Propionate .5 mg/g 68462-0529-17 Glenmark 1 tube $0.224 FDA listed +57%
Clobetasol Propionate .5 mg/g 00168-0162-15 E. 15 g $0.295 AB FDA listed +107%
Clobetasol Propionate .5 mg/g 70710-1401-01 Zydus 1 tube $0.329 AB FDA listed +131%
Clobetasol Propionate .5 mg/g 68462-0530-17 Glenmark 1 tube $0.329 FDA listed +131%
Clobetasol Propionate .5 mg/g 16714-0782-01 Northstar 1 tube $0.329 Discontinued +131%
Clobetasol Propionate (emollient) .5 mg/g 00168-0301-15 E. 1 tube $0.590 AB2 Availability likely +313%
Clobetasol Propionate .5 mg/g 51672-1297-01 Sun 1 tube $0.597 AB2 Availability likely +318%
Clobetasol Propionate (emollient) .5 mg/g 83148-0064-15 The 1 tube $0.597 AB2 Availability likely +318%
Clobetasol Propionate .5 mg/g 00168-0293-15 E. 15 g $0.666 AB FDA listed +367%
Clobetasol Propionate .5 mg/g 45802-0925-14 Padagis 1 tube $0.710 AB Availability likely +398%
Clobetasol Propionate .5 mg/g 51672-1294-01 Sun 1 tube $0.710 AB Availability likely +398%
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
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 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 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 46708-0465-15 Alembic 1 tube AB FDA listed
Clobetasol Propionate .5 mg/g 68071-3922-05 NuCare 1 tube AB FDA listed
Clobetasol Propionate .5 mg/g 70771-1209-01 Zydus 1 tube AB FDA listed
Clobetasol Propionate .5 mg/g 72162-1438-02 Bryant 1 tube AB FDA listed
Clobetasol Propionate (emollient) .5 mg/g 72162-2628-02 Bryant 1 tube AB2 FDA listed
Clobetasol Propionate .5 mg/g 63629-8639-01 Bryant 1 tube AB FDA listed
Clobetasol Propionate .5 mg/g 50090-8001-00 A-S 1 tube AB 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

🏛️
2024
On the market since
Dec 2024
📍
2026
Currently FDA-listed
2 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 13668-0569-05, 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 · 2 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
44
Units reimbursed last 4 qtrs
2.9K
Gross reimbursed last 4 qtrs
$1K
Avg / prescription
$22.88
Avg / unit
$0.3424
Latest quarter Q4 2025
44Rx
Medicaid pays / g
$0.3424
gross reimbursed
vs
NADAC / g
$0.1427
acquisition cost
=
Spread
+$0.1997
+140% 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
100% MCO
Fee-for-service · 0 Rx Managed care · 44 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 660 units · 9.6 per 100k residents IN Ohio: no data reported OH Pennsylvania: 780 units · 6.0 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 1,500 units · 24.3 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
6.024.3
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
🏆 Top states by units · per 100k residents
1 Maryland 24.3 /100k
2 Indiana 9.6 /100k
3 Pennsylvania 6.0 /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.
15 gs13668-0569-01 12 Rx · $274
30 gs13668-0569-02 No Medicaid data
45 gs13668-0569-04 No Medicaid data
Drug total (last 4 qtrs): 56 Rx · 3,495 units · $1,281 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

10,471 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization2,013
Life-threatening245
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1,338 630
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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
13668-0569-01 15 g in 1 TUBE (13668-569-01) $0.1884 / g $2.83 2019-12-30 Active
13668-0569-02 30 g in 1 TUBE (13668-569-02) $0.1681 / g $5.04 2019-12-30 Active
13668-0569-04 45 g in 1 TUBE (13668-569-04) $0.1158 / g $5.21 2020-01-30 Active
13668-0569-05 You're viewing this 60 g in 1 TUBE (13668-569-05) $0.1427 / g $8.56 2019-12-30 Active

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

Per g, this pack runs about 23% above the cheapest pack (45 g, $0.1158 vs $0.1427 NADAC).

Pack size FAQ

What quantity is in NDC 13668-0569-05?
NDC 13668-0569-05 contains 60 g — 60 g in 1 tube.
What is the difference between NDC 13668-0569-05 and NDC 13668-0569-01?
Both are Clobetasol Propionate .5 mg/g Cream — the drug itself is identical. NDC 13668-0569-05 is the 60 g package, while NDC 13668-0569-01 is the 15 g package. Per-g NADAC also differs: $0.1427 here vs $0.1884 for the 15 g pack.
What NDC number is used to bill for this package of Clobetasol Propionate .5 mg/g Cream?
Bill NDC 13668-0569-05 — the 11-digit billing format is 13668056905. 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 97 words

INDICATIONS AND USAGE Clobetasol propionate cream USP 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 96 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 a super-high potency topical corticosteroid; 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.

Contraindications 22 words

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

🤒 Adverse Reactions 115 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 formulation.

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.

🆘 Overdosage 19 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 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 cream indicate that it is in the super-high range of potency as compared with other topical corticosteroids.

📦 How Supplied / Storage and Handling 61 words

HOW SUPPLIED Clobetasol propionate cream, USP, 0.05% is supplied in 15-g (NDC 13668-569-01), 30-g (NDC 13668-569-02), 45-g (NDC 13668-569-04) and 60-g (NDC 13668-569-05) tubes. Store between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature]. Do not refrigerate. Manufactured by: Torrent Pharmaceuticals LTD., Pithampur-454775, INDIA. Manufactured for: Torrent Pharma INC., Basking Ridge, NJ 07920 March 2026 RL-no. 8102287 Image

📋 Description 136 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 (11ß, 16ß)-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 empirical 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 contains clobetasol propionate 0.5 mg/g in a cream base of cetyl alcohol, citric acid anhydrous, glycol stearate, lanolin oil, methylparaben, polyoxyl 8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum (white soft paraffin). Sodium hydroxide may be used to adjust pH.

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