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Halobetasol Propionate .5 mg/g Lotion — NDC 85437-0008-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Halobetasol Propionate .5 mg/g Lotion — NDC 85437-008-60 (Billing 85437-0008-60)

by Coral Way Pharma, LLC · 1 BOTTLE in 1 CARTON / 59 g in 1 BOTTLE

This is a package of Halobetasol Propionate .5 mg/g Lotion from Coral Way Pharma, LLC, marketed since Mar 2026 and currently FDA-listed, this package's marketing is listed to end May 2027. It is this product's only package size.

NDC 85437-0008-60
🏷️ FDA NDC (as labeled) 85437-008-60 billing pads the product segment with a zero
Rx only Brand 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

NDC database record

One package, one record: these facts belong to NDC 85437-008-60 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
85437 labeler · 008 product · 60 package
Package marketed since
Mar 10, 2026
Package marketing ended
May 31, 2027
Sample package
No — commercial package
Barcode (UPC-A, from the NDC)
3 8543700860 8
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85437-008-60
Product NDC 85437-008
11-digit billing NDC 85437000860
NCPDP billing unit ML — per mL (volume)
RxCUI 1789962
UNII 91A0K1TY3Z
Application # NDA208183
SPL Set ID 4cb1f7b3-c412-6fc7-e063-6394a90a63c9
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-10
Marketing end 2027-05-31
Route TOPICAL
Dosage form LOTION
Substance HALOBETASOL PROPIONATE

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

GPI-14 90550073104110
GCN Seq No 075826
GCN 40975
HICL code 006037
Ingredient (HICL) Halobetasol 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 HALOBETASOL PROP 0.05% LOTION
FDB brand name Halobetasol Propionate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 075826
  • GCN: 40975
  • GPI-14 (Medi-Span): 90550073104110
  • HICL (First Databank): 006037
  • AHFS class code: 84:06.08.00
  • RxCUI (RxNorm): 1789962
Why two NDCs? The FDA registers this code as 85437-008-60 — 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 → 85437-0008-60. 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, potent (group III)
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 HALOBETASOL PROP 0.05% LOTION Ingredient Halobetasol Propionate
📖 What it is MedlinePlus · NLM

Halobetasol topical is used to treat redness, swelling, itching, and discomfort of various skin conditions in adults and children 12 years of age and older, including plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Halobetasol is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Halobetasol topical is used to treat inflammatory skin conditions — conditions that cause redness, swelling, and itching. The ointment form is used broadly for skin conditions that...
  • You should use halobetasol topical for no longer than two consecutive weeks, and no more than 50 grams total per week. It's a very potent steroid, and using it longer or in larger...
  • Yes — avoid applying halobetasol to your face, groin, or underarms. These areas have thinner skin and absorb much more of the medication, increasing your risk of side effects. Also...
  • Are there places I should not apply this?
📖 Read our full Halobetasol Topical guide →

Supplement & herbal interactions

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

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Halobetasol Propionate (3 interactions) — ranked by severity →
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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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 Marketing startMarketing endStatus
85437-0008-60 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 59 g in 1 BOTTLE 2026-03-10 May 31, 2027 Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Halobetasol Propionate .5 mg/g 45802-0131-32 Padagis 1 tube $0.397 AB Availability likely —
Halobetasol Propionate .5 mg/g 45802-0129-32 Padagis 1 tube $0.409 AB Availability likely —
Halobetasol Propionate .5 mg/g 00713-0640-15 Cosette 15 g $0.648 AB Availability likely —
Halobetasol Propionate .5 mg/g 70752-0119-02 QUAGEN 1 tube $0.843 AB Availability likely —
Halobetasol Propionate .5 mg/g 00713-0339-15 Cosette 1 tube $0.843 AB Availability likely —
Ultravate .5 mg/g 73159-0008-60 Lacer 1 bottle — — FDA listed —
Halobetasol Propionate .5 mg/gthis 85437-0008-60 Coral 1 bottle — — FDA listed —
Halobetasol Propionate .5 mg/g 72162-2258-02 Bryant 1 tube — AB FDA listed —
Halobetasol Propionate .5 mg/g 63629-8665-01 Bryant 1 tube — AB FDA listed —
Halobetasol Propionate .5 mg/g 72162-1396-02 Bryant 1 tube — AB FDA listed —
Halobetasol Propionate .5 mg/g 72162-2331-02 Bryant 1 tube — AB FDA listed —
Halobetasol Propionate .5 mg/g 63629-8664-01 Bryant 1 tube — AB FDA listed —
Halobetasol Propionate .5 mg/g 72162-2067-02 Bryant 1 tube — AB FDA listed —
Halobetasol Propionate .5 mg/g 21922-0108-04 Encube 1 tube — AB FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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

🏛️
2015
First FDA approval
Nov 2015
📍
2026
Currently FDA-listed
11 years listed
🛡️
2033
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jun 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Nov 6, 2015 RLD RS ⏳ ~6.7 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8962028 — method of use (U-1775)
2015 2017 2019 2021 2023 2025 2027 2029 2031 2033
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (1)
PatentTypeUse codeExpires
US 8962028 ↗ Method of use U-1775 Jun 19, 2033
Common questions
Is there a generic version of HALOBETASOL PROP 0.05% LOTION?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for HALOBETASOL PROP 0.05% LOTION. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

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 3QPI1U3FV8
    A preservative derived from benzoic acid that prevents bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII I835H2IHHX
    A waxy substance derived from plant oils, used as an emulsifier and solubilizer to help mix oil and water ingredients together and keep them blended throughout the product's shelf life.
  • 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 P7E6YFV72X
    Diisopropyl adipate is a clear, oily liquid derived from adipic acid. It acts as a plasticizer and solvent in medicines, helping soften coatings and improve how the drug dissolves or spreads in the body.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 461N1O614Y
    A synthetic oily liquid used as an emollient and solvent in medications. It helps dissolve active ingredients and improves how the medicine spreads or absorbs through the skin.
  • UNII TUF2IVW3M2
    Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
  • 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 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.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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 DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
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

LabelerCoral Way Pharma, LLC
Application holderLACER PHARMA LLC
FDA applicationNDA208183 (NDA AUTHORIZED GENERIC)
Labeler code85437
First marketedMar 2026
Product typeHuman Prescription Drug
Portfolio4 products on file

More NDCs from Coral Way Pharma, LLC labeler code 85437

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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 51 words ▾

1 INDICATIONS AND USAGE Halobetasol Propionate Lotion 0.05% is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. Halobetasol Propionate Lotion 0.05% is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. ( 1 )

⏱️ Dosage and Administration 216 words ▾

2 DOSAGE AND ADMINISTRATION Apply a thin layer of Halobetasol Propionate Lotion 0.05% to the affected skin twice daily for up to two weeks. Rub in gently. Discontinue therapy when control is achieved.

If no improvement is seen within two weeks, reassessment of diagnosis may be necessary. Treatment beyond two weeks is not recommended and the total dosage should not exceed 50 grams (50 ml) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis {see Warnings and Precautions 5.1 ].Do not use with occlusive dressings unless directed by a physician. Halobetasol Propionate Lotion 0.05% is for external use only.

Avoid use on the face, scalp, groin, or axillae. Halobetasol Propionate Lotion 0.05% is not for ophthalmic, oral, or intravaginal use. Apply a thin layer to the affected areas twice daily.

( 2 ) Limit use to 50 g/week. ( 2 ) Discontinue treatment when control is achieved. ( 2 ) If no improvement is seen within 2 weeks, reassess diagnosis.

( 2 ) Treatment beyond 2 consecutive weeks is not recommended. ( 2 ) Do not use with occlusive dressings unless directed by a physician. ( 2 ) Avoid use on the face, scalp, groin, or axillae.

( 2 ) Not for ophthalmic, oral, or intravaginal use. ( 2 )

💊 Dosage Forms and Strengths 33 words ▾

3 DOSAGE FORMS AND STRENGTHS Halobetasol Propionate Lotion, 0.05% is a white to off-white lotion. Each gram of Halobetasol Propionate Lotion contains 0.5 mg of halobetasol propionate. Halobetasol PropionateLotion: 0.05% (0.5 mg/g). (3)

⛔ Contraindications 5 words ▾

4 CONTRAINDICATIONS None. None (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS - Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency during or after treatment. Systemic absorption may require evaluation for HPA axis suppression. ( 5.1 ) Systemic effects of topical corticosteroids may also include Cushing's syndrome, hyperglycemia, and glucosuria.

Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure. ( 5.1 ) Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. ( 5.1 , 8.4 ) Local adverse reactions with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis.

Adverse reactions may be more likely to occur with occlusive use or more potent corticosteroids. ( 5.2 , 5.5 ) Topical corticosteroids may increase the risk of cataract and glaucoma formation. If visual symptoms occur, consider referral to an ophthalmologist tor evaluation.

( 5.3 ) Initiate appropriate therapy if concomitant skin infections develop. ( 5.4 )

5.1Effects on Endocrine System Halobetasol Propionate Lotion 0.05% has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.Systemic effects of topical corticosteroids may include reversible HPA axis suppression, with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of treatment of the topical corticosteroid.The potential for hypothalamic-pituitary adrenal (HPA) suppression with Halobetasol Propionate Lotion 0.05% was evaluated in the following studies: In a study of 20 adult subjects with moderate to severe plaque psoriasis involving 􀃙20% of their body surtace area.Halobetasol Propionate Lotion 0.05% produced HPA axis suppression when used twice daily for two weeks in 5 out of 20 (25%) adult subjects with plaque psoriasis.

The effects of HPA axis suppression were reversible on discontinuation of the treatment [see Clinical Pharmacology ( 12.2 )] . In another clinical study, 16 adolescent subjects (12 to less than 17 years old) with moderate to severe plaque psoriasis involving 10% or more of their body surtace area applied a maximum of approximately 50 grams of Halobetasol Propionate Lotion 0.05% to affected areas twice daily for two weeks. Of the 14 subjects evaluated for HPA axis suppression, adrenal suppression occurred in 1 subject (7%) which recovered upon retest [see Clinical Pharmacology ( 12.2 )] .

Because of the potential for systemic absorption, use of topical corticosteroids, including Halobetasol Propionate Lotion 0.05%, may require that patients be evaluated periodically for evidence of HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent corticosteroids, use over large surtace areas, prolonged use, occlusive use, use on an altered skin barrier, concomitant use of multiple corticosteroid-containing products, liver failure, and young age.

An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, attempt to gradually withdraw the drug, reduce the frequency of application, or substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.Systemic effects of topical corticosteroids may also include Cushing's syndrome, hyperglycemia, and glucosuria. Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure to topical corticosteroids. Pediatric patients may be more susceptible than adults to systemic toxicity from the use of topical corticosteroids due to their larger surtace-to-body mass ratios [see Use in Specific… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS - The most commonly reported adverse reactions (≥1%) are telangiectasia, application site atrophy, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Coral Way Pharma, LLC at 1-888-403-8874 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . See 17 for PATIENT CONSELING INFORMATION Revised: 03/2026

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. During randomized, controlled, blinded clinical trials 277 adults with plaque psoriasis were treated with Halobetasole Propionate Lotion 0.05% twice daily for up to two weeks (up to approximately 50 grams/week). Table 1 presents adverse reactions that occured in at least 1% of subjects treated with Halobetasol Propionate Lotion 0,05% twice daily for up to two weeks, and more frequently than in vehicle-treated subjects.

Tale 1: Adverse Reactions Occurring in ≥ 1% of Subjects Treated with Halobetasol Propionate Lotion 0.05% for up to Two Weeks 0.05% Halobetasol Propionate Lotion 0.05% (N=277) Vehicle Lotion (N=259) Adverse Reaction % % Telangiectasia 1% 0% Application site atrophy 1% <1% Headache 1% <1% Less common dverse reactions (incidence less than 1% but greater than 0.1%) that occured in subjects treated with Halobetasol Propionate Lotion 0,05% included application site discoloration, herpes zoster, influenza, nasopharyngitis, otitis media acute, throat infection, wound, and increased blood pressure.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS -

8.1Pregnancy There are no available data on Halobetasol Propionate Lotion 0.05% use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published data report an increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during pregnancy. In animal reproduction studies, halobetasol propionate administered systemically during organogenesis to pregnant rats at 13 and 33 times the human topical dose and to pregnant rabbits at 3 times the human topical dose resulted in teratogenic and embryotoxic effects [see Data].

The clinical relevance of the animal findings is not clear. The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data Human Data Multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality. However, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants. Animal Data Halobetasol propionate has been shown to be teratogenic in rats and rabbits when given systemically during organogenesis at doses of 0.04 to 0.1 mg/kg/day in rats and 0.01 mg/kg/day in rabbits.

These doses are approximately 13, 33, and 3 times, respectively, the human topical dose of halobetasol propionate, 0.05%. Halobetasol propionate was embryotoxic in rabbits but not in rats.Cleft palate was observed in both rats and rabbits. Omphalocele was seen in rats, but not in rabbits.

8.2Lactation - Risk Summary There are no data on the presence of halobetasol propionate or its metabolites in human milk, the effects on the breastted infant, or the effects on milk production after topical application to women who are breastteeding. Systemically administered corticosteroids appear in human milk and could suppress growth, intertere 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.

The developmental and health benefits of breastteeding should be considered along with the mother's clinical need for Halobetasol Propionate Lotion 0.05% and any potentialadverse effects on the breastted infant from Halobetasol Propionate Lotion 0.05% or from the underlying maternal condition. Clinical Considerations Advise breastfeeding women not to apply Halobetasol Propionate Lotion 0.05% directly to the nipple and areola to avoid direct infant exposure.

8.4Pediatric Use Safety and effectiveness of Halobetasol Propionate Lotion 0.05% for the treatment of moderate to severe plaque psoriasis have been established in patients 12 years of age and older. It is supported by evidence from adequate and well-controlled trials in adults and from one uncontrolled safety trial in 16 adolescents (12 to less than 17 years of age). Adolescent patients with moderate to severe plaque psoriasis covering a minimum of 10% of the total body surface area were treated twice daily for 2 weeks with Halobetasol Propionate Lotion 0.05%.

Hypothalamic-pituitary adrenal (HPA) axis function (ACTH stimulation test) was evaluated in a subset of 14 patients. After 2 weeks of treatment, 1 of 14 patients (7%) experienced laboratory evidence of adrenal suppression (i.e., cortisol serum level of sl 8 μg/dL) that recovered upon retest. No other adverse reactions were reported in the study.

Because of higher skin surtace area to body mass ratios, pediatric patients are at a greater risk than adults of… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy There are no available data on Halobetasol Propionate Lotion 0.05% use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published data report an increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during pregnancy. In animal reproduction studies, halobetasol propionate administered systemically during organogenesis to pregnant rats at 13 and 33 times the human topical dose and to pregnant rabbits at 3 times the human topical dose resulted in teratogenic and embryotoxic effects [see Data].

The clinical relevance of the animal findings is not clear. The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data Human Data Multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality. However, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants. Animal Data Halobetasol propionate has been shown to be teratogenic in rats and rabbits when given systemically during organogenesis at doses of 0.04 to 0.1 mg/kg/day in rats and 0.01 mg/kg/day in rabbits.

These doses are approximately 13, 33, and 3 times, respectively, the human topical dose of halobetasol propionate, 0.05%. Halobetasol propionate was embryotoxic in rabbits but not in rats.Cleft palate was observed in both rats and rabbits. Omphalocele was seen in rats, but not in rabbits.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Safety and effectiveness of Halobetasol Propionate Lotion 0.05% for the treatment of moderate to severe plaque psoriasis have been established in patients 12 years of age and older. It is supported by evidence from adequate and well-controlled trials in adults and from one uncontrolled safety trial in 16 adolescents (12 to less than 17 years of age). Adolescent patients with moderate to severe plaque psoriasis covering a minimum of 10% of the total body surface area were treated twice daily for 2 weeks with Halobetasol Propionate Lotion 0.05%.

Hypothalamic-pituitary adrenal (HPA) axis function (ACTH stimulation test) was evaluated in a subset of 14 patients. After 2 weeks of treatment, 1 of 14 patients (7%) experienced laboratory evidence of adrenal suppression (i.e., cortisol serum level of sl 8 μg/dL) that recovered upon retest. No other adverse reactions were reported in the study.

Because of higher skin surtace area to body mass ratios, 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 reactions including striae have been reported with 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 63 words ▾

8.5Geriatric Use Clinical studies with Halobetasol Propionate Lotion 0.05% included 89 subjects aged 65 years and over. No overall differences in safety or effectiveness were observed between these subjects and those younger than 65 years. Clinical studies of Halobetasol Propionate Lotion 0.05% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🆘 Overdosage 24 words ▾

10 OVERDOSAGE Topically applied Halobetasol Propionate Lotion 0.05% can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1) ].

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY -

12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in plaque psoriasis is unknown.

12.2Pharmacodynamics Vasoconstriction: A vasoconstrictor assay in healthy subjects with Halobetasol Propionate Lotion 0.05% indicated that the formulation is in the super-high range of potency as compared to other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence. Hypothalamic-Pituitaty-Adrenal (HPA) Axis Suppression: The potential for hypothalamic-pituitary adrenal (HPA) suppression was evaluated in the following two studies. In both studies, the criteria for HPA-axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (adrenocorticotropic hormone, ACTH).

In the first study, Halobetasol Propionate Lotion 0.05% was applied to 20 adult subjects with moderate to severe plaque psoriasis. A mean dose of 3.5 grams Halobetasol Propionate Lotion 0.05% was applied twice daily for two weeks and produced HPA axis suppression in 5 of 20 (25%) subjects. The effects of HPA axis suppression were reversible on retesting at least four weeks after discontinuation of the treatment.

In the second study, Halobetasol Propionate Lotion 0.05% was applied to 16 adolescent subjects 12 years to less than 17 years of age with moderate to severe plaque psoriasis affecting a mean body surtace area of 11.5% (range from 10% to 14%). The mean dose was 3.6 grams applied twice daily for two weeks. A subset of 14 of the 16 completed subjects had evaluable ACTH stimulation tests, and HPA axis suppression was observed in 1 of these 14 subjects (7%).

In the second study also, the effects of HPA axis suppression were reversible on retesting at least four weeks after discontinuation of the treatment.

12.3Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

In the HPA clinical study /see Clinical Pharmacology (12.2)1, pharmacokinetics was evaluated in a subgroup of 12 adult subjects. On Day 8, blood was taken just prior to and at 1, 2, 4, 6, 8, and 12 hours following the last application. Plasma concentration of halobetasol propionate (HBP) was measurable in all subjects.

Based on the geometric mean plasma concentrations at 12 hours post-application across time, steady-state was achieved by Day 8. The mean (±standard deviation) C max concentrations for Halobetasol Propionate Lotion 0.05% on Day 8 was 201.1 ± 157.5 pg/ml, with the corresponding median T max value of 3 hours (range O - 6 hours); mean area under the halobetasol propionate concentration versus time curve over the dosing interval (AUCt) was 1632 ± 1147 pg•h/ml. Specific Populations Pediatric Patients In the pediatric HPA study [see Clinical Pharmacology (12.2)] , trough plasma concentrations of HBP were measured on Day 8 and Day 15 in a subset of 14 subjects.

The HBP levels in the plasma were below the quantification limit (20 pg/ml) for all subjects at all time points with the exception of one subject at Day 15 (trough concentration of HBP of 28.2 pg/ml).

🧬 Mechanism of Action 28 words ▾

12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in plaque psoriasis is unknown.

📦 How Supplied / Storage and Handling 73 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING - Halobetasol Propionate Lotion 0.05 % is white to off-white lotion. It is supplied in an oval tapered white high-density polyethylene bottle with a white polypropylene disc cap. Each bottle contains 60 ml (59 g) of Halobetasol Propionate Lotion 0.05%. NDC 85437-008-60 ml (59 g) bottle Store at 25'C (77'F); excursions permitted to 15°G and 30°G (59° F to 86°F) [see USP Controlled Room Temperature]. Do not freeze.

📋 Description 121 words ▾

11 DESCRIPTION Halobetasol Propionate Lotion 0.05% for topical use contains a corticosteroid, halobetasol propionate. The chemical name of halobetasol propionate is 21­ chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17­ propionate. Halobetasol propionate is a white to off-white crystalline powder with a molecular weight of 484.96 and a molecular formula of C 25 H 31 ClF 2 O 5 .

It is practically insoluble in water and freely soluble in dichloromethane and in acetone. It has the following structural formula: Each gram of Halobetasol Propionate Lotion 0.05% contains 0.5 mg of halobetasol propionate in a white to off-white lotion base consisting of diisopropyl adipate, octyldodecanol, ceteth-20, poloxamer 407, cetyl alcohol, stearyl alcohol, propylparaben, butylparaben, propylene glycol, glycerin, carbomer homopolymer, sodium hydroxide, and water. Struct

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

In the HPA clinical study /see Clinical Pharmacology (12.2)1, pharmacokinetics was evaluated in a subgroup of 12 adult subjects. On Day 8, blood was taken just prior to and at 1, 2, 4, 6, 8, and 12 hours following the last application. Plasma concentration of halobetasol propionate (HBP) was measurable in all subjects.

Based on the geometric mean plasma concentrations at 12 hours post-application across time, steady-state was achieved by Day 8. The mean (±standard deviation) C max concentrations for Halobetasol Propionate Lotion 0.05% on Day 8 was 201.1 ± 157.5 pg/ml, with the corresponding median T max value of 3 hours (range O - 6 hours); mean area under the halobetasol propionate concentration versus time curve over the dosing interval (AUCt) was 1632 ± 1147 pg•h/ml. Specific Populations Pediatric Patients In the pediatric HPA study [see Clinical Pharmacology (12.2)] , trough plasma concentrations of HBP were measured on Day 8 and Day 15 in a subset of 14 subjects.

The HBP levels in the plasma were below the quantification limit (20 pg/ml) for all subjects at all time points with the exception of one subject at Day 15 (trough concentration of HBP of 28.2 pg/ml).

🧬 Pharmacodynamics ~1 min read ▾

12.2Pharmacodynamics Vasoconstriction: A vasoconstrictor assay in healthy subjects with Halobetasol Propionate Lotion 0.05% indicated that the formulation is in the super-high range of potency as compared to other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence. Hypothalamic-Pituitaty-Adrenal (HPA) Axis Suppression: The potential for hypothalamic-pituitary adrenal (HPA) suppression was evaluated in the following two studies. In both studies, the criteria for HPA-axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (adrenocorticotropic hormone, ACTH).

In the first study, Halobetasol Propionate Lotion 0.05% was applied to 20 adult subjects with moderate to severe plaque psoriasis. A mean dose of 3.5 grams Halobetasol Propionate Lotion 0.05% was applied twice daily for two weeks and produced HPA axis suppression in 5 of 20 (25%) subjects. The effects of HPA axis suppression were reversible on retesting at least four weeks after discontinuation of the treatment.

In the second study, Halobetasol Propionate Lotion 0.05% was applied to 16 adolescent subjects 12 years to less than 17 years of age with moderate to severe plaque psoriasis affecting a mean body surtace area of 11.5% (range from 10% to 14%). The mean dose was 3.6 grams applied twice daily for two weeks. A subset of 14 of the 16 completed subjects had evaluable ACTH stimulation tests, and HPA axis suppression was observed in 1 of these 14 subjects (7%).

In the second study also, the effects of HPA axis suppression were reversible on retesting at least four weeks after discontinuation of the treatment.

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES Halobetasol Propionate Lotion 0.05% was evaluated for the treatment of moderate to severe plaque psoriasis in two multicenter, randomized, doble-blind, vehicle-controlled trials. These trials were conducted in 443 subjects 18 years of age and older with plaque psoriasis involving between 2% and 12% body surface area. Baseline disease severity was determined using a static, five-level global evaluation scale, on which a subject scored either moderate or severe.

Overall, 57% of subjects were male and 86% were Caucasian. Subjects applied Halobatesol Propionate Lotion 0.05% or vehicle to all affected areas twice daily for up to 14 consecutive days. The primary measure of efficacy was Overall Treatment Success, defined as the proportion of subjects who were cleared or almost cleared with at least a two grade improvement from baseline at Week 2 (end of treatment).

Table 2 presents these results. Table 2: Overall Treatment Success in Subjects with Plaque Psoriasis at Week 2 Study 1 Study 2 Halobetasol Propionate Lotion 0.05% N=110 Vehicle Lotion N=76 Halobetasol Propionate Lotion 0.05% N=110 Vehicle Lotion N=112 Overall Treatment Success Subject whose condition was cleared or almost cleared of all signs of psoriasis and with at least a two grade improvement from baseline. 49 (44.5%) 7 (6.3%) 49 (44.5%) 8 (7.1%) The secondary measures of efficacy were Treatment Success for individual signs of psoriasis (scaling, erythema, and plaque elevation) at the end of treatment (see Table 3).

Table 3: Individual Signs Treatment Success in Subjects with Plaque Psoriasis at Week 2 Study 1 Study 2 Treatment Success Subjects who were cleared or almost cleared of the designated clinical sign with at least a two grade improvement from baseline. Halobetasol Propionate Lotion 0.05% N=10 Vehicle Lotion N=111 Halobetasol Propionate Lotion 0.05% N=110 Vehicle Lotion N=112 Scaling 61 (55.5%) 12 (10.8%) 65 (59.1%) 11 (9.8%) Erythema 40 (36.4%) 8 (7.2%) 48 (43.6%) 12 (10.7%) Plaque Elevation 50 (45.5%) 9 (8.1%) 48 (43.6%) 9 (8.0%)

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY -

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol propionate. In a 90-day repeat-dose toxicity study in rats, topical administration of Halobetasol Propionate Topical Foam at dose concentrations from 0.005% to 0.05% or from 0.011 to 0.11 mg/kg/day of halobetasol propionate resulted in a toxicity profile consistent with long-term exposure to corticosteroids including adrenal atrophy, histopathological changes in several organ systems indicative of severe immune suppression, and opportunistic fungal and bacterial infections.

A no observable adverse effect level could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk of carcinogenesis. Halobetasol propionate was not found to be genotoxic in the Ames/Salmonella assay, in the Chinese hamster CHO/HGPRT assay, in the mouse micronucleus test, in the sister chromatid exchange test in somatic cells of the Chinese hamster, or in the chromosome aberration test in somatic cells of Chinese hamsters.

Positive mutagenicity effects were observed in two genotoxicity assays: Chinese hamster nuclear anomaly test and mouse lymphoma gene mutation assay in vitro. Studies in the rat following oral administration at dose levels up to 0.05 mg/kg/day indicated no impairment of fertility or general reproductive performance.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 219 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol propionate. In a 90-day repeat-dose toxicity study in rats, topical administration of Halobetasol Propionate Topical Foam at dose concentrations from 0.005% to 0.05% or from 0.011 to 0.11 mg/kg/day of halobetasol propionate resulted in a toxicity profile consistent with long-term exposure to corticosteroids including adrenal atrophy, histopathological changes in several organ systems indicative of severe immune suppression, and opportunistic fungal and bacterial infections.

A no observable adverse effect level could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk of carcinogenesis. Halobetasol propionate was not found to be genotoxic in the Ames/Salmonella assay, in the Chinese hamster CHO/HGPRT assay, in the mouse micronucleus test, in the sister chromatid exchange test in somatic cells of the Chinese hamster, or in the chromosome aberration test in somatic cells of Chinese hamsters.

Positive mutagenicity effects were observed in two genotoxicity assays: Chinese hamster nuclear anomaly test and mouse lymphoma gene mutation assay in vitro. Studies in the rat following oral administration at dose levels up to 0.05 mg/kg/day indicated no impairment of fertility or general reproductive performance.

📄 Recent Major Changes 14 words ▾

Indication and Usage ( 1 ) 08/2020 Warnings and Precautions ( 5.1 ) 08/2020

📄 Package Label / Principal Display Panel 28 words ▾

PRINCIPAL DISPLAY PANEL - 59 g Canister Carton NDC 85437-008-60 Halobetasol Propionate Lotion, 0.05% For topical use only. Rx ONLY Net Wt. 60 mL (59 g) bottle Label-HP

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Halobetasol Propionate — the program that covers self-administered drugs. 4 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 Halobetasol 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
$2.1M
Claims incl. refills
39.2K
Beneficiaries
28.4K
Spend / beneficiary
$73.82
Spend / claim
$53.58
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.

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Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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Yes, per the latest FDA NDC Directory data on this page it is currently marketed — but Coral Way Pharma, LLC has reported a marketing end date of 2027-05-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
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← 85437-0004-60 · Coral 85437-0093-06 · Coral →
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