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Enstilar calcipotriene and betamethasone dipropionate 50 ug/g; .5 mg/g Aerosol, Foam — NDC 50222-0302-91 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Enstilar calcipotriene and betamethasone dipropionate 50 ug/g; .5 mg/g Aerosol, Foam — NDC 50222-302-91 (Billing 50222-0302-91)

by LEO Pharma Inc. · 1 CAN in 1 CARTON / 60 g in 1 CAN

This is a package of Enstilar calcipotriene and betamethasone dipropionate 50 ug/g; .5 mg/g Aerosol, Foam from LEO Pharma Inc., marketed since Oct 2015 and currently FDA-listed.

NDC 50222-0302-91
🏷️ FDA NDC (as labeled) 50222-302-91 billing pads the product segment with a zero
This package
Contains60 g in 1 can Pack sizes3 compare ↓
Also priced by: Part D plans $21.56/unit — full pricing hub ↓
Product page 50222-0302-60 Also comes in: 60 g 50222-302-60 2 cans 50222-302-66
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 27, 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 50222-302-91 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
50222 labeler · 302 product · 91 package
Package marketed since
Oct 16, 2015
Sample package
Yes — professional sample, not for sale
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5022230291 9
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50222-302-91
Product NDC 50222-302
11-digit billing NDC 50222030291
RxCUI 1716094, 1716099
UNII S7499TYY6G, 826Y60901U
Application # NDA207589
SPL Set ID d1193df2-d53f-4342-bd9d-d9cba7c89709
Established class (EPC) Corticosteroid; Vitamin D Analog
Mechanism of action Corticosteroid Hormone Receptor Agonists
Chemical class Vitamin D
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-10-16
Route TOPICAL
Dosage form AEROSOL, FOAM
Substance CALCIPOTRIENE MONOHYDRATE; BETAMETHASONE DIPROPIONATE

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

GPI-14 90559902323930
GPI class Enstilar
GCN Seq No 075371
GCN 40449
HICL code 022851
Ingredient (HICL) Calcipotriene/Betamethasone
HIC1 code T
Therapeutic class — broad (HIC1) Ear,Eye,Nose,Rectum,Top,Vag.,Spec.senses(Q Cont.)
HIC2 code T0
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin (Q5 Cont'd)
HIC3 code T0A
Therapeutic class — specific (HIC3) Topical Vit D Analog/Anti-Inflammatory Steroid
AHFS code 84:24.12.00
AHFS class Basic Ointments And Protectants
FDB label name ENSTILAR 0.005%-0.064% FOAM
FDB brand name Enstilar
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 075371
  • GCN: 40449
  • GPI-14 (Medi-Span): 90559902323930
  • HICL (First Databank): 022851
  • AHFS class code: 84:24.12.00
  • RxCUI (RxNorm): 1716094
Why two NDCs? The FDA registers this code as 50222-302-91 — 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 → 50222-0302-91. 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 acting locally, Corticosteroids, 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 ENSTILAR 0.005%-0.064% FOAM Ingredient Calcipotriene/Betamethasone
📗 Our plain-language guide HelloPharmacist
  • It treats plaque psoriasis. Depending on the product, it is approved for scalp psoriasis, body psoriasis, or both. Check which one you were given.
  • Usually once a day until the psoriasis is controlled, up to 4 or 8 weeks depending on the product. Stay within the weekly limit on your label and follow your prescriber.
  • Avoid the face, groin, and underarms, and skin that has become thin. Keep it out of your eyes and do not use it by mouth or vaginally. Don't cover it with tight dressings unless yo...
  • Itching, scaly rash, redness, or burning where you apply it are the common ones. Call your doctor if you notice vision changes, skin that isn't healing, or your psoriasis getting w...
📖 Read our full Betamethasone / Calcipotriene guide →

Supplement & herbal interactions

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

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $21.56 $1,293.76 / 60 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
50222-0302-60 50222-302-60 Main listing 1 CAN in 1 CARTON / 60 g in 1 CAN $21.84 / g $1,310.38 2015-10-16 — Active
50222-0302-66 50222-302-66 2 CAN in 1 CARTON / 60 g in 1 CAN — — 2015-10-16 — Active
50222-0302-91 You're viewing this 1 CAN in 1 CARTON / 60 g in 1 CAN Sample — — 2015-10-16 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 can in 1 carton / 60 g in 1 can.
What NDC number is used to bill for this package of Enstilar calcipotriene and betamethasone dipropionate 50 ug/g; .5 mg/g Aerosol, Foam?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Enstilar 50 ug/g; .5 mg/gthis 50222-0302-91 LEO 1 can — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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
Oct 2015
📍
2026
Currently FDA-listed
11 years listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2031. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 16, 2015 RLD RS ⏳ ~5.2 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.

When could a generic Enstilar arrive?

Our estimate: 2027 to 2028 a wide window

How sure: Probable. More likely than not, but it can still move.

Why then: The brand company and a generic maker settled their patent fight and agreed on when a generic can launch.

That is before the December 2031 date above, which is common: a court ruling or a deal with the brand’s maker often lets a generic in before the last patent runs out.

See the full forecast for generic Enstilar →
Patents & exclusivity — FDA Orange Book
US 9119781 — method of use (U-1761)
US 9119781 — method of use (U-2627)
US 10688108 — method of use (U-2627)
US 10660908 — method of use (U-2627)
US 9566286 — drug product
US 10130640 — drug product
US 10617698 — drug product
US 10682364 — drug product
US 10716799 — drug product
US 9119781*PED — drug product
US 10130640*PED — drug product
2015 2017 2019 2021 2023 2025 2027 2029 2031
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 (11)
PatentTypeUse codeExpires
US 9119781 ↗ Method of use U-1761 Jun 10, 2031
US 9119781 ↗ Method of use U-2627 Jun 10, 2031
US 10688108 ↗ Method of use U-2627 Jun 10, 2031
US 10660908 ↗ Method of use U-2627 Jun 10, 2031
US 9566286 ↗ Drug product — Jun 10, 2031
US 10130640 ↗ Drug product — Jun 10, 2031
US 10617698 ↗ Drug product — Jun 10, 2031
US 10682364 ↗ Drug product — Jun 10, 2031
US 10716799 ↗ Drug product — Jun 10, 2031
US 9119781*PED ↗ Drug product — Dec 10, 2031
US 10130640*PED ↗ Drug product — Dec 10, 2031
Common questions
Is there a generic version of ENSTILAR 0.005%-0.064% FOAM?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for ENSTILAR 0.005%-0.064% FOAM. See the alternatives section for substitutable, lower-cost products. An approval does not always mean it is on pharmacy shelves yet: we expect the first generic Enstilar between 2027 and 2028. See the forecast.
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.

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.

🧪 Avoiding an ingredient? See Betamethasone / Calcipotriene inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 7QWA1RIO01
    A synthetic form of vitamin E used as an antioxidant in medicines. It prevents oils and fats in the formulation from breaking down, helping the drug remain stable and effective during storage.
  • UNII 6LV4FOR43R
    Butane is a colorless gas derived from petroleum. In medicines, it serves as a propellant in inhalers and aerosol sprays, helping deliver the active drug to the lungs or skin.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII AM13FS69BX
    Dimethyl ether is a gas that becomes liquid when pressurized. It's used in medicines as a propellant to help deliver the active ingredient from aerosol containers, similar to how spray cans work.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • 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 S4G2J0Y0LG
    PPG-11 stearyl ether is a synthetic compound made from propylene glycol and stearyl alcohol. It acts as an emulsifier and solubilizer in medicines, helping blend oil and water-based ingredients and improve how the drug dissolves or spreads.

7 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

LabelerLEO Pharma Inc.
Application holderLEO PHARMA AS
FDA applicationNDA207589 (NDA)
Labeler code50222
First marketedOct 2015
Product typeHuman Prescription Drug
Portfolio8 products on file

More NDCs from LEO Pharma Inc. labeler code 50222

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 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 59 words ▾

1 INDICATIONS AND USAGE Enstilar ® (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years and older. Enstilar Foam is a combination of calcipotriene, a vitamin D analog, and betamethasone dipropionate, a corticosteroid, indicated for the topical treatment of plaque psoriasis in patients 12 years and older. ( 1 )

⏱️ Dosage and Administration 175 words ▾

2 DOSAGE AND ADMINISTRATION Shake can prior to using Enstilar Foam. Apply Enstilar Foam to affected areas once daily for up to 4 weeks. The maximum dose should not exceed 60 grams every 4 days.

Rub in Enstilar Foam gently. Wash hands after applying the product. Discontinue Enstilar Foam when control is achieved.

Enstilar Foam should not be used: with occlusive dressings unless directed by a healthcare provider. on the face, groin, or axillae, or if skin atrophy is present at the treatment site. Enstilar Foam is not for oral, ophthalmic, or intravaginal use. Shake before use.

Apply Enstilar Foam to affected area(s) once daily for up to 4 weeks. Discontinue therapy when control is achieved. Do not use more than 60 grams every 4 days.

( 2 ) Do not use with occlusive dressings unless directed by a healthcare provider. ( 2 ) Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. ( 2 ) Not for oral, ophthalmic, or intravaginal use.

( 2 )

💊 Dosage Forms and Strengths 77 words ▾

3 DOSAGE FORMS AND STRENGTHS Enstilar Foam: 0.005%/0.064% - each gram contains 50 mcg calcipotriene and 0.643 mg of betamethasone dipropionate in a white to off-white opalescent liquid in a pressurized aluminum spray can with a continuous valve and actuator. At administration the product is a white to off-white foam after evaporation of the propellants. Foam: 0.005%/0.064% - Each gram of Enstilar Foam contains 50 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate.

( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Flammability: The propellants in Enstilar Foam are flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. ( 5.1 ) Hypercalcemia and Hypercalciuria: Hypercalcemia and hypercalciuria have been observed with use of Enstilar Foam.

If hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized. ( 5.2 ) Effects on Endocrine System: Topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factors include the use of high-potency topical corticosteroids, use over a large surface area or on areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients.

Modify use should HPA axis suppression develop. ( 5.3 , 8.4 ) Ophthalmic Adverse Reactions: Topical corticosteroid products may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist.

( 5.5 )

5.1Flammability The propellants in Enstilar Foam are flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application.

5.2Hypercalcemia and Hypercalciuria Hypercalcemia and hypercalciuria have been observed with use of Enstilar Foam. If hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized. The incidence of hypercalcemia and hypercalciuria following Enstilar Foam treatment of more than 56 weeks has not been evaluated [ s ee Clinical Pharmacology (12.2) ].

5.3Effects on Endocrine System Hypothalamic-Pituitary-Adrenal Axis Suppression Systemic absorption of topical corticosteroids can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of treatment. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.

Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. If HPA axis suppression is documented, gradually withdraw Enstilar Foam, reduce the frequency of application, or substitute with a less potent corticosteroid. The following trials evaluated the effects of Enstilar Foam on HPA axis suppression [ see Clinical Pharmacology (12.2) ]: In a trial evaluating the effects of Enstilar Foam on the HPA axis, 35 adult subjects applied Enstilar Foam on the body and scalp.

Adrenal suppression was not observed in any subjects after 4 weeks of treatment. In another trial, 33 adolescent subjects age 12 to 17 years applied Enstilar Foam on the body and scalp. Adrenal suppression occurred in 3 (9%) of the subjects.

In a trial, 21 subjects aged 18 years and older with plaque psoriasis applied Enstilar Foam once daily for 4 weeks and then twice weekly on 2 non-consecutive days for 52 weeks, including once daily for 4 weeks if loss of response occurred. Adrenal suppression was observed in 2 (10%) of the subjects. Cushing's Syndrome and Hyperglycemia Systemic effects of topical corticosteroids may also include Cushing's syndrome, hyperglycemia, and glucosuria.

Additional Considerations for Endocrine Adverse Reactions Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4) ] . Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.

5.4Allergic Contact Dermatitis Allergic contact dermatitis has been observed with topical calcipotriene and topical corticosteroids. Allergic contact dermatitis to a topica… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Adverse reactions reported in < 1% of subjects included application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerbation of psoriasis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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. Clinical Trials Conducted in Subjects 18 years and older with Psoriasis The rates of adverse reactions described below were from three randomized, multicenter, vehicle and/or active-controlled clinical trials in adult subjects with plaque psoriasis [see Clinical Studies (14) ] .

Subjects applied study product once daily for 4 weeks, and the median weekly dose of Enstilar Foam was 25 grams. Adverse reactions reported in <1% of adult subjects treated with Enstilar Foam included: application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerbation of psoriasis. Clinical Trials Conducted in Subjects 12 to 17 years with Psoriasis In one uncontrolled clinical trial, 106 subjects aged 12 to 17 years with plaque psoriasis of the scalp and body applied Enstilar Foam once daily for up to 4 weeks.

The median weekly dose was 40 grams. Adverse reactions reported in <1% of adolescent subjects treated were acne, erythema, application site pain, and skin reactions [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.2) ].

6.2Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Postmarketing reports for local adverse reactions to Enstilar Foam included application site burning. Postmarketing reports for local adverse reactions to topical corticosteroids included atrophy, striae, telangiectasia, dryness, perioral dermatitis, secondary infection, and miliaria.

Ophthalmic adverse reactions of cataracts, glaucoma, and increased intraocular pressure have been reported with the use of topical corticosteroids, including topical betamethasone products.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data with Enstilar Foam are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. Although there are no available data on use of the calcipotriene component in pregnant women, systemic exposure to calcipotriene after topical administration of Enstilar Foam is likely to be low [see Clinical Pharmacology (12.3) ]. Observational studies suggest an increased risk of having low birth weight infants with the maternal use of potent or super potent topical corticosteroids (see Data ).

Advise pregnant women that Enstilar ® Foam may increase the potential risk of having a low birth weight infant and to use Enstilar Foam on the smallest area of skin and for the shortest duration possible. In animal reproduction studies, oral administration of calcipotriene to pregnant rats during the period of organogenesis resulted in an increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs (see Data ). Oral administration of calcipotriene to pregnant rabbits during the period of organogenesis had no apparent effects on embryo-fetal development.

Subcutaneous administration of betamethasone dipropionate to pregnant rats and rabbits during the period of organogenesis resulted in fetal toxicity, including fetal deaths, reduced fetal weight, and fetal malformations (cleft palate and crooked or short tail) (see Data ) . The available data do not allow the calculation of relevant comparisons between the systemic exposures of calcipotriene and betamethasone dipropionate observed in animal studies to the systemic exposures that would be expected in humans after topical use of Enstilar Foam.

The background risk of major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Human Data Available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency. However, when the dispensed amount of potent or super potent topical corticosteroids exceeded 300 grams during the entire pregnancy, maternal use was associated with an increased risk of low birth weight in infants. Animal Data Embryo-fetal development studies with calcipotriene were performed by the oral route in rats and rabbits.

Pregnant rats received dosages of 0, 6, 18, or 54 mcg/kg/day (0, 36, 108, and 324 mcg/m 2 /day, respectively) on days 6-15 of gestation (the period of organogenesis). There were no apparent effects on maternal survival, behavior, or body weight gain, no effects on litter parameters, and no effects on the incidence of major malformations in fetuses. Fetuses from dams dosed at 54 mcg/kg/day exhibited a significantly increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs.

Pregnant rabbits were dosed daily with calcipotriene at exposures of 0, 4, 12, or 36 mcg/kg/day (0, 48, 144, and 432 mcg/m 2 /day, respectively) on days 6-18 of gestation (the period of organogenesis). Mean maternal body weight gain was reduced in animals dosed at 12 or 36 mcg/kg/day. The incidence of fetal deaths was increased in the group dosed at 36 mcg/kg/day; reduced fetal weight was also observed in this group.

The incidence of major malformations among fetuses was not affected. An increase in the incidence of minor skeletal abnormalities, including incomplete ossification of sternebrae, pubic bones, and forelimb phalanges, was observed in the group dosed at 36 mcg/kg/day. Embryo-fetal development studies with betamethasone dipropionate were performed via subcutaneous inj… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Available data with Enstilar Foam are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. Although there are no available data on use of the calcipotriene component in pregnant women, systemic exposure to calcipotriene after topical administration of Enstilar Foam is likely to be low [see Clinical Pharmacology (12.3) ]. Observational studies suggest an increased risk of having low birth weight infants with the maternal use of potent or super potent topical corticosteroids (see Data ).

Advise pregnant women that Enstilar ® Foam may increase the potential risk of having a low birth weight infant and to use Enstilar Foam on the smallest area of skin and for the shortest duration possible. In animal reproduction studies, oral administration of calcipotriene to pregnant rats during the period of organogenesis resulted in an increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs (see Data ). Oral administration of calcipotriene to pregnant rabbits during the period of organogenesis had no apparent effects on embryo-fetal development.

Subcutaneous administration of betamethasone dipropionate to pregnant rats and rabbits during the period of organogenesis resulted in fetal toxicity, including fetal deaths, reduced fetal weight, and fetal malformations (cleft palate and crooked or short tail) (see Data ) . The available data do not allow the calculation of relevant comparisons between the systemic exposures of calcipotriene and betamethasone dipropionate observed in animal studies to the systemic exposures that would be expected in humans after topical use of Enstilar Foam.

The background risk of major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Human Data Available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency. However, when the dispensed amount of potent or super potent topical corticosteroids exceeded 300 grams during the entire pregnancy, maternal use was associated with an increased risk of low birth weight in infants. Animal Data Embryo-fetal development studies with calcipotriene were performed by the oral route in rats and rabbits.

Pregnant rats received dosages of 0, 6, 18, or 54 mcg/kg/day (0, 36, 108, and 324 mcg/m 2 /day, respectively) on days 6-15 of gestation (the period of organogenesis). There were no apparent effects on maternal survival, behavior, or body weight gain, no effects on litter parameters, and no effects on the incidence of major malformations in fetuses. Fetuses from dams dosed at 54 mcg/kg/day exhibited a significantly increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs.

Pregnant rabbits were dosed daily with calcipotriene at exposures of 0, 4, 12, or 36 mcg/kg/day (0, 48, 144, and 432 mcg/m 2 /day, respectively) on days 6-18 of gestation (the period of organogenesis). Mean maternal body weight gain was reduced in animals dosed at 12 or 36 mcg/kg/day. The incidence of fetal deaths was increased in the group dosed at 36 mcg/kg/day; reduced fetal weight was also observed in this group.

The incidence of major malformations among fetuses was not affected. An increase in the incidence of minor skeletal abnormalities, including incomplete ossification of sternebrae, pubic bones, and forelimb phalanges, was observed in the group dosed at 36 mcg/kg/day. Embryo-fetal development studies with betamethasone dipropionate were performed via subcutaneous injection in mice and rabbits.

Pr… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of Enstilar Foam for the treatment of mild to severe plaque psoriasis have been established in pediatric patients age 12 to 17 years. The use of Enstilar Foam for this indication is supported by evidence from adequate and well-controlled trials in adults and from one uncontrolled trial in 106 adolescents age 12 to 17 years with psoriasis of the body and scalp. Calcium metabolism was evaluated in all pediatric subjects and no cases of hypercalcemia or clinically relevant changes in urinary calcium were reported.

Hypothalamic pituitary adrenal (HPA) axis suppression was evaluated in a subset of 33 pediatric subjects with moderate plaque psoriasis of the body and scalp (mean body surface area involvement of 16% and mean scalp area involvement of 56%). After 4 weeks of once daily treatment with a mean weekly dose of 47 grams, HPA axis suppression was observed in 3 of 33 subjects (9%) [see Warnings and Precautions (5.2) , Adverse Reactions (6.1) and Clinical Pharmacology (12.2) ]. Because of a higher ratio of skin surface area to body mass, children under the age of 12 years are at particular risk of systemic adverse effects when they are treated with topical corticosteroids.

Pediatric patients are, therefore, also at greater risk of HPA axis suppression and adrenal insufficiency with the use of topical corticosteroids including Enstilar Foam [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.2) ]. Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients treated with topical corticosteroids. Local adverse reactions including striae have been reported with use of topical corticosteroids in pediatric patients.

The safety and effectiveness of Enstilar Foam in pediatric patients less than 12 years of age have not been established.

🧓 Geriatric Use 76 words ▾

8.5Geriatric Use Of the total number of subjects in the controlled clinical studies of Enstilar Foam, 97 subjects were 65 years and over, and 21 were 75 and over. No overall differences in safety or effectiveness of Enstilar Foam were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Enstilar Foam combines the pharmacological effects of calcipotriene hydrate as a synthetic vitamin D3 analog and betamethasone dipropionate as a synthetic corticosteroid. However, while their pharmacologic and clinical effects are known, the exact mechanisms of their actions in the treatment of plaque psoriasis are unknown.

12.2Pharmacodynamics Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression: HPA axis suppression as indicated by a 30-minute post-stimulation cortisol level of ≤18 mcg/dL was evaluated in the following trials [see Warnings and Precautions (5.3) ] : Enstilar Foam was applied to adult subjects (N=35) with moderate to severe plaque psoriasis affecting a mean body surface area of 18% (range 12 to 28%) and mean scalp area of 50 % (range 30 to 100%). The mean ± SD weekly dose used was 62 ± 28 grams. HPA axis suppression was not observed in any subjects after 4 weeks of treatment.

Lack of adrenal suppression observed in this trial does not rule out the risk of HPA axis suppression. Enstilar Foam was applied to adolescent subjects (N=33) age 12 to 17 years with moderate plaque psoriasis affecting a mean body surface area of 16% (range from 10% to 21%) and mean scalp area of 56% (range from 25% to 90%). The mean ± SD weekly dose used was 47 ± 22 grams.

HPA axis suppression was observed in 3 (9%) of the subjects. Enstilar ® Foam was applied once daily for 4 weeks to adult subjects (N=21) with plaque psoriasis affecting a mean body surface area of 15% (range 10 to 30%), then twice weekly on 2 non-consecutive days for 52 weeks with 4 weeks and once daily treatment was resumed if loss of response occurred. The mean ± SD total dose used in the 52-week period was 1400 ± 905 grams (including total dose of 528 ± 650 grams used in the loss of response period).

HPA axis suppression was observed in 2 (10%) of the subjects at Week 56. Effects on Calcium Metabolism Effects of once daily application of Enstilar Foam for 4 weeks on calcium metabolism in adult subjects (N=564) with plaque psoriasis were examined in three randomized, multicenter, vehicle- and/or active-controlled clinical trials. Following once daily application of Enstilar Foam, elevated serum calcium levels outside the normal range were observed in 3 subjects.

Elevated urinary calcium levels outside the normal range were observed in 17 subjects. In a trial, calcium metabolism was evaluated in 106 adolescent subjects aged 12 to 17 years with plaque psoriasis of the scalp and body after once daily application of Enstilar Foam for 4 weeks. No cases of hypercalcemia and no clinically relevant changes in urinary calcium were reported.

In a trial, 272 subjects aged 18 years and older with plaque psoriasis applied Enstilar Foam once daily for 4 weeks and then twice weekly on 2 non-consecutive days for 52 weeks, including once daily for 4 weeks if loss of response occurred. No cases of hypercalcemia and no clinically relevant changes in urinary calcium were reported. Vasoconstrictor Assay Enstilar Foam is in the mid to potent range corticosteroid as demonstrated by studies in healthy subjects when compared with other topical corticosteroids.

However, similar blanching scores do not necessarily imply therapeutic equivalence.

12.3Pharmacokinetics Absorption The PK of Enstilar Foam was investigated in both adults (N = 35) and a subset of pediatric subjects with plaque psoriasis age 12 to 17 years (N=33) following once daily application of Enstilar Foam on the body and scalp for 4 weeks. Enstilar Foam was applied to adult subjects with moderate to severe plaque psoriasis affecting a mean body surface area of 18% and mean scalp area of 50%. Following application of a mean ± SD weekly dose of 62 ± 28 grams of Enstilar Foam, calcipotriene was quantifiable in 1 of 35 (3%) subjects and its main metabolite, MC1080, in 3 of 35 (9%) subjects.

For subjects with measurable concentrations, the maximal plasma concentrations (C max ) and… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 49 words ▾

12.1Mechanism of Action Enstilar Foam combines the pharmacological effects of calcipotriene hydrate as a synthetic vitamin D3 analog and betamethasone dipropionate as a synthetic corticosteroid. However, while their pharmacologic and clinical effects are known, the exact mechanisms of their actions in the treatment of plaque psoriasis are unknown.

📦 How Supplied / Storage and Handling 151 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Enstilar (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064% is a white to off-white opalescent liquid in a pressurized aluminum spray can with a continuous valve and actuator. At administration, the product is a white to off-white foam after evaporation of the propellants. It is available as: 60 gram can (NDC 50222-302-60) 120 gram (2 cans of 60 gram) (NDC 50222-302-66)

16.2Storage Store Enstilar Foam at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F). [See USP controlled room temperature]. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C). Do not freeze. Unused product should be discarded six months after the can has been opened. Keep out of the reach of children.

16.3Handling Enstilar Foam is flammable; avoid heat, flame or smoking when using this product.

📦 Storage and Handling 84 words ▾

16.2Storage Store Enstilar Foam at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F). [See USP controlled room temperature]. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C). Do not freeze. Unused product should be discarded six months after the can has been opened. Keep out of the reach of children.

16.3Handling Enstilar Foam is flammable; avoid heat, flame or smoking when using this product.

📋 Description ~1 min read ▾

11 DESCRIPTION Enstilar Foam contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only. Calcipotriene Hydrate Calcipotriene hydrate is a synthetic vitamin D analog and has the chemical name 9,10-secochola-5,7,10(19),22-tetraene-1,3,24-triol,24-cyclo-propyl-,monohydrate, (1α,3β,5Z,7E,22E,24S) with the empirical formula C 27 H 40 O 3 ∙H 2 O), a molecular weight of 430.6, and the following structural formula (calcipotriene hydrate is a white to almost white, crystalline compound): Chemical Structure Betamethasone Dipropionate Betamethasone dipropionate is a synthetic corticosteroid and has the chemical name pregna-1,4-diene-3,20-dione-9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxypropoxy)-(11β,16β), with the empirical formula C 28 H 37 FO 7 , a molecular weight of 504.6, and the following structural formula (betamethasone dipropionate is a white to almost white, crystalline powder): Chemical Structure Enstilar ® Foam Each gram of Enstilar Foam contains 50 mcg of calcipotriene (equivalent to 52.2 mcg of calcipotriene hydrate) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of white petrolatum, polyoxypropylene stearyl ether, mineral oil, all- rac -alpha-tocopherol, and butylhydroxytoluene.

Enstilar Foam is a white to off-white opalescent liquid in a pressurized aluminum spray can with a continuous valve and actuator. The propellants used in Enstilar Foam are dimethyl ether and butane. At administration, the product is a white to off-white foam after evaporation of the propellants.

Enstilar Foam has the appearance of a non-expanding foam that gradually collapses after spraying.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling ( Patient Information and Instructions for Use ). Flammability Instruct patients that Enstilar Foam is flammable; avoid heat, flame, or smoking when applying this medication. Administration Instructions Shake before use and spray the foam by holding the can in any orientation except horizontally.

Gently rub in Enstilar Foam to your affected areas. Do not use more than 60 grams every 4 days. Discontinue therapy when control is achieved unless directed otherwise by the healthcare provider.

Avoid use of Enstilar Foam on the face, underarms, groin or eyes. If this medicine gets on face or in mouth or eyes, wash area right away. Do not occlude the treatment area with a bandage or other covering unless directed by the healthcare provider.

Instruct the patients not to use other products containing calcipotriene or a corticosteroid with Enstilar Foam without first talking to the healthcare provider. Wash hands after application. Local Reactions and Skin Atrophy Advise patients that local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids.

Hypercalcemia and Hypercalciuria Advise patients that hypercalcemia and hypercalciuria have been observed with the use of Enstilar Foam [see Warnings and Precautions (5.2) ]. HPA Axis Suppression, Cushing's Syndrome, and Hyperglycemia Advise patients that Enstilar Foam can cause HPA axis suppression, Cushing's syndrome, and/or hyperglycemia [see Warnings and Precautions (5.3) ]. Ophthalmic Adverse Reactions Advise patients to avoid contact of Enstilar Foam with eyes and to report any visual symptoms [see Warnings and Precautions (5.5) ].

Pregnancy and Lactation Advise pregnant women that Enstilar Foam may increase the potential risk of having a low birth weight infant and to use Enstilar Foam on the smallest area of skin and for the shortest duration possible [see Use in Specific Populations (8.1) ]. Advise breastfeeding women not to apply Enstilar Foam directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.2) ] .

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Absorption The PK of Enstilar Foam was investigated in both adults (N = 35) and a subset of pediatric subjects with plaque psoriasis age 12 to 17 years (N=33) following once daily application of Enstilar Foam on the body and scalp for 4 weeks. Enstilar Foam was applied to adult subjects with moderate to severe plaque psoriasis affecting a mean body surface area of 18% and mean scalp area of 50%. Following application of a mean ± SD weekly dose of 62 ± 28 grams of Enstilar Foam, calcipotriene was quantifiable in 1 of 35 (3%) subjects and its main metabolite, MC1080, in 3 of 35 (9%) subjects.

For subjects with measurable concentrations, the maximal plasma concentrations (C max ) and area under the concentration curve until the last measured time point (AUC last ) for calcipotriene were 55.9 pg/mL and 82.5 pg*h/mL, respectively; and the mean ± SD C max and AUC last for MC1080 was 24.4 ± 1.9 pg/mL and 59.3 ± 5.4 pg*h/mL, respectively. Betamethasone dipropionate was quantifiable in 5 of 35 (14%) subjects and its main metabolite, betamethasone 17-propionate (B17P), was quantifiable in 27 of 35 (77%) subjects.

The mean ± SD C max and AUC last for betamethasone dipropionate were 52.2 ± 19.7 pg/mL and 36.5 ± 27.4 pg*h/mL, respectively and for B17P were 147.9 ± 224.0 pg/mL and 683.6 ± 910.6 pg*h/mL, respectively. Enstilar Foam was applied to pediatric subjects age 12 to 17 years with moderate plaque psoriasis affecting a mean body surface area of 16% and mean scalp area of 56%. Following application of a mean ± SD weekly dose of 47 ± 22 grams of Enstilar Foam, calcipotriene and its metabolite MC1080 were below the lower limit of quantification in all plasma samples.

Betamethasone dipropionate was quantifiable in 12 of 33 (36%) subjects with the C max ranging from 31.1-480 pg/mL. The metabolite of betamethasone 17-propionate (B17P) was quantifiable in 6 of 33 (18%) subjects with the C max ranging from 30.8–91.7 pg/mL. Elimination Metabolism Calcipotriene: Calcipotriene metabolism following systemic uptake is rapid and occurs in the liver.

The primary metabolites of calcipotriene are less potent than the parent compound. Calcipotriene is metabolized to MC1046 (the α,β-unsaturated ketone analog of calcipotriene), which is metabolized further to MC1080 (a saturated ketone analog). MC1080 is the major metabolite in plasma.

MC1080 is slowly metabolized to calcitroic acid. Betamethasone dipropionate : Betamethasone dipropionate is metabolized to betamethasone 17-propionate (B17P) and betamethasone, including the 6β-hydroxy derivatives of those compounds by hydrolysis. Betamethasone 17-propionate (B17P) is the primary metabolite.

🧬 Pharmacodynamics ~2 min read ▾

12.2Pharmacodynamics Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression: HPA axis suppression as indicated by a 30-minute post-stimulation cortisol level of ≤18 mcg/dL was evaluated in the following trials [see Warnings and Precautions (5.3) ] : Enstilar Foam was applied to adult subjects (N=35) with moderate to severe plaque psoriasis affecting a mean body surface area of 18% (range 12 to 28%) and mean scalp area of 50 % (range 30 to 100%). The mean ± SD weekly dose used was 62 ± 28 grams. HPA axis suppression was not observed in any subjects after 4 weeks of treatment.

Lack of adrenal suppression observed in this trial does not rule out the risk of HPA axis suppression. Enstilar Foam was applied to adolescent subjects (N=33) age 12 to 17 years with moderate plaque psoriasis affecting a mean body surface area of 16% (range from 10% to 21%) and mean scalp area of 56% (range from 25% to 90%). The mean ± SD weekly dose used was 47 ± 22 grams.

HPA axis suppression was observed in 3 (9%) of the subjects. Enstilar ® Foam was applied once daily for 4 weeks to adult subjects (N=21) with plaque psoriasis affecting a mean body surface area of 15% (range 10 to 30%), then twice weekly on 2 non-consecutive days for 52 weeks with 4 weeks and once daily treatment was resumed if loss of response occurred. The mean ± SD total dose used in the 52-week period was 1400 ± 905 grams (including total dose of 528 ± 650 grams used in the loss of response period).

HPA axis suppression was observed in 2 (10%) of the subjects at Week 56. Effects on Calcium Metabolism Effects of once daily application of Enstilar Foam for 4 weeks on calcium metabolism in adult subjects (N=564) with plaque psoriasis were examined in three randomized, multicenter, vehicle- and/or active-controlled clinical trials. Following once daily application of Enstilar Foam, elevated serum calcium levels outside the normal range were observed in 3 subjects.

Elevated urinary calcium levels outside the normal range were observed in 17 subjects. In a trial, calcium metabolism was evaluated in 106 adolescent subjects aged 12 to 17 years with plaque psoriasis of the scalp and body after once daily application of Enstilar Foam for 4 weeks. No cases of hypercalcemia and no clinically relevant changes in urinary calcium were reported.

In a trial, 272 subjects aged 18 years and older with plaque psoriasis applied Enstilar Foam once daily for 4 weeks and then twice weekly on 2 non-consecutive days for 52 weeks, including once daily for 4 weeks if loss of response occurred. No cases of hypercalcemia and no clinically relevant changes in urinary calcium were reported. Vasoconstrictor Assay Enstilar Foam is in the mid to potent range corticosteroid as demonstrated by studies in healthy subjects when compared with other topical corticosteroids.

However, similar blanching scores do not necessarily imply therapeutic equivalence.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Two multicenter, randomized, double-blind trials were conducted in adult subjects with plaque psoriasis. In Trial One, 302 subjects were randomized to 1 of 3 treatment groups: Enstilar ® Foam, betamethasone dipropionate in the same vehicle, or calcipotriene in the same vehicle. In Trial Two, 426 subjects were randomized to one of two treatment groups: Enstilar Foam or the vehicle alone.

Baseline disease severity was graded using a 5-point Investigator's Global Assessment (IGA). At baseline subjects scored "Mild", "Moderate", or "Severe". The majority of subjects in both trials (76% and 75%) had disease of "Moderate" severity at baseline, 14% and 15% of subjects had disease of "Mild" severity at baseline and 10% of subjects had "Severe" disease at baseline in both trials.

The extent of disease involvement assessed by mean body surface area was 7.1% (range 2 to 28%) and 7.5% (range 2 to 30%). In both trials, subjects were treated once daily for up to 4 weeks. Efficacy was assessed with treatment success defined as the proportion of subjects at Week 4 who were "Clear" or "Almost Clear" according to the IGA.

Subjects with "Mild" disease at baseline were required to be "Clear" to be considered a treatment success. Table 1 presents the efficacy results for these trials. Table 1.

Percentage of Subjects Achieving Treatment Success According to the Investigator's Global Assessment of Disease Severity Subjects with "Mild" disease at baseline were required to be "Clear" to be considered a treatment success. Enstilar Foam Betamethasone dipropionate in vehicle Calcipotriene in vehicle Vehicle Trial One Week 4 (N=100) 45.0% (N=101) 30.7% (N=101) 14.9% - - Trial Two Week 4 (N=323) 53.3% - - - - (N=103) 4.8% Long-term Use A randomized, double-blind, vehicle-controlled trial (NCT02899962) evaluated the long-term use of Enstilar Foam in subjects who achieved treatment success (defined as IGA score of "Clear" or "Almost Clear" with at least a 2 grade improvement from baseline) after an initial 4-week treatment with once daily Enstilar Foam.

These subjects (N=521) were randomized to receive Enstilar Foam or vehicle foam twice weekly on 2 non-consecutive days for up to 52 additional weeks. Subjects experiencing loss of response (defined as an IGA score of at least "Mild") were treated once daily with Enstilar ® Foam for 4 weeks, and those who regained an IGA score of "Clear" or "Almost Clear" after 4 weeks then continued randomized treatment. Disease severity was graded using a 5-point IGA.

The majority of subjects in this trial (82%) had disease of "Moderate" severity at baseline, 11% of subjects had disease of "Mild" severity at baseline, and 7% of subjects had "Severe" disease at baseline. The extent of disease involvement assessed by mean body surface area was 8.3% (range 1 to 38%) at baseline. The median time to loss of response was 56 days for subjects treated with Enstilar Foam twice weekly compared to 30 days for subjects treated with vehicle foam twice weekly.

Over the 52-week assessment period, subjects in the Enstilar Foam twice weekly group experienced loss of response a median of 2.0 times compared to 3.0 times for subjects in the vehicle foam twice weekly group. Figure 1 presents the percentage of subjects maintaining an IGA score of "Clear" or "Almost Clear" through Week 52 after randomization. Figure 1: Percentage of Subjects Maintaining an IGA Score of "Clear" or "Almost Clear" Through Week 52 After Randomization Figure 1

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility When calcipotriene was applied topically to mice for up to 24 months at dosages of 3, 10, and 30 mcg/kg/day (9, 30, and 90 mcg/m 2 /day, respectively), no significant changes in tumor incidence were observed when compared to control. A 104-week oral carcinogenicity study was conducted with calcipotriene in male and female rats at doses of 1, 5, and 15 mcg/kg/day (6, 30, and 90 mcg/m 2 /day, respectively). Beginning week 71, the dosage for high-dose animals of both genders was reduced to 10 mcg/kg/day (60 mcg/m 2 /day).

A treatment-related increase in benign C-cell adenomas was observed in the thyroid of females that received 15 mcg/kg/day. A treatment-related increase in benign pheochromocytomas was observed in the adrenal glands of males that received 15 mcg/kg/day. No other statistically significant differences in tumor incidence were observed when compared to control.

The relevance of these findings to patients is unknown. When betamethasone dipropionate was applied topically to CD-1 mice for up to 24 months at dosages approximating 1.3, 4.2, and 8.5 mcg/kg/day in females, and 1.3, 4.2, and 12.9 mcg/kg/day in males (up to 26 mcg/m 2 /day and 39 mcg/m 2 /day, in females and males, respectively), no significant changes in tumor incidence were observed when compared to control. When betamethasone dipropionate was administered via oral gavage to male and female Sprague Dawley rats for up to 24 months at dosages of 20, 60, and 200 mcg/kg/day (120, 360, and 1200 mcg/m 2 /day, respectively), no significant changes in tumor incidence were observed when compared to control.

Calcipotriene did not elicit any genotoxic effects in the Ames mutagenicity assay, the mouse lymphoma TK locus assay, the human lymphocyte chromosome aberration test, or the mouse micronucleus test. Betamethasone dipropionate did not elicit any genotoxic effects in the Ames mutagenicity assay, the mouse lymphoma TK locus assay, or in the rat micronucleus test. Studies in rats with oral doses of up to 54 mcg/kg/day (324 mcg/m 2 /day) of calcipotriene indicated no impairment of fertility or general reproductive performance.

Studies in male rats at oral doses of up to 200 mcg/kg/day (1200 mcg/m 2 /day), and in female rats at oral doses of up to 1000 mcg/kg/day (6000 mcg/m 2 /day), of betamethasone dipropionate indicated no impairment of fertility.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility When calcipotriene was applied topically to mice for up to 24 months at dosages of 3, 10, and 30 mcg/kg/day (9, 30, and 90 mcg/m 2 /day, respectively), no significant changes in tumor incidence were observed when compared to control. A 104-week oral carcinogenicity study was conducted with calcipotriene in male and female rats at doses of 1, 5, and 15 mcg/kg/day (6, 30, and 90 mcg/m 2 /day, respectively). Beginning week 71, the dosage for high-dose animals of both genders was reduced to 10 mcg/kg/day (60 mcg/m 2 /day).

A treatment-related increase in benign C-cell adenomas was observed in the thyroid of females that received 15 mcg/kg/day. A treatment-related increase in benign pheochromocytomas was observed in the adrenal glands of males that received 15 mcg/kg/day. No other statistically significant differences in tumor incidence were observed when compared to control.

The relevance of these findings to patients is unknown. When betamethasone dipropionate was applied topically to CD-1 mice for up to 24 months at dosages approximating 1.3, 4.2, and 8.5 mcg/kg/day in females, and 1.3, 4.2, and 12.9 mcg/kg/day in males (up to 26 mcg/m 2 /day and 39 mcg/m 2 /day, in females and males, respectively), no significant changes in tumor incidence were observed when compared to control. When betamethasone dipropionate was administered via oral gavage to male and female Sprague Dawley rats for up to 24 months at dosages of 20, 60, and 200 mcg/kg/day (120, 360, and 1200 mcg/m 2 /day, respectively), no significant changes in tumor incidence were observed when compared to control.

Calcipotriene did not elicit any genotoxic effects in the Ames mutagenicity assay, the mouse lymphoma TK locus assay, the human lymphocyte chromosome aberration test, or the mouse micronucleus test. Betamethasone dipropionate did not elicit any genotoxic effects in the Ames mutagenicity assay, the mouse lymphoma TK locus assay, or in the rat micronucleus test. Studies in rats with oral doses of up to 54 mcg/kg/day (324 mcg/m 2 /day) of calcipotriene indicated no impairment of fertility or general reproductive performance.

Studies in male rats at oral doses of up to 200 mcg/kg/day (1200 mcg/m 2 /day), and in female rats at oral doses of up to 1000 mcg/kg/day (6000 mcg/m 2 /day), of betamethasone dipropionate indicated no impairment of fertility.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION ENSTILAR ® [EN-still-ar] (calcipotriene and betamethasone dipropionate) Foam This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 4/2022 Important: Enstilar Foam is for use on skin only (topical).

Do not get Enstilar Foam near or in your mouth, eyes, or vagina. There are other medicines that contain the same medicine that is in Enstilar Foam and are used to treat plaque psoriasis. Do not use other products containing calcipotriene or a corticosteroid medicine with Enstilar Foam without talking to your healthcare provider first.

What is Enstilar Foam? Enstilar Foam is a prescription medicine used on the skin (topical) to treat plaque psoriasis in people 12 years of age and older. It is not known if Enstilar Foam is safe and effective in children under 12 years of age.

Before you use Enstilar Foam, tell your healthcare provider about all of your medical conditions, including if you: have a calcium metabolism disorder. Have thinning skin (atrophy) at the treatment site are pregnant or plan to become pregnant. It is not known if Enstilar Foam will harm your unborn baby.

Enstilar Foam may increase your chance of having a low birth weight baby. If you use Enstilar Foam during pregnancy, use Enstilar Foam on the smallest area of the skin and for the shortest time needed. are breastfeeding or plan to breastfeed. It is not known if Enstilar Foam passes into your breast milk.

Breastfeeding women should use Enstilar Foam on the smallest area of the skin and for the shortest time needed. Do not apply Enstilar Foam directly to your nipple and areola to avoid contact with your baby. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

How should I use Enstilar Foam? See the " Instructions for Use " for detailed information about the right way to use Enstilar Foam. Use Enstilar Foam exactly as your healthcare provider tells you to use it.

Your healthcare provider should tell you how much Enstilar Foam to use and where to use it. Apply Enstilar Foam to the affected areas of your skin 1 time a day for up to 4 weeks. You should stop treatment when your plaque psoriasis is under control unless your healthcare provider gives you other instructions.

Do not use more than 60 grams of Enstilar Foam every 4 days. Do not use Enstilar Foam longer than prescribed. Using too much Enstilar Foam, or using it too often, or for too long can increase your risk for having serious side effects.

Shake the Enstilar Foam can before you use it. Gently rub in Enstilar Foam to your affected areas. Avoid using Enstilar Foam on your face, groin, or armpits, or if you have thinning of your skin (atrophy) at the treatment site.

If you accidentally get Enstilar Foam on your face, in your mouth or in your eyes, wash the area with water right away. Wash your hands after using Enstilar Foam unless you are using the medicine to treat your hands. Do not bandage or cover the treated skin area, unless instructed by your healthcare provider.

What should I avoid while using Enstilar Foam? Enstilar Foam is flammable. Avoid fire, flame, and smoking when applying and right after you apply Enstilar Foam.

What are the possible side effects of Enstilar Foam? Enstilar Foam may cause serious side effects, including: Too much calcium in your blood or urine. Your healthcare provider may tell you to stop or temporarily stop treatment with Enstilar Foam if you have too much calcium in your blood or urine.

Your healthcare provider may do blood and urine tests to check your calcium levels and adrenal gland function while you are using Enstilar Foam. Enstilar ® Foam can pass through your skin. Too much Enstilar Foam passing through your skin can cause your adrenal glands to stop working properly.

Your healthcare provider may do blood tests to check for adrenal gland problems. Your healthcare provider may tell you to stop or temporarily sto… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~2 min read ▾

INSTRUCTIONS FOR USE ENSTILAR ® [EN-still-ar] (calcipotriene and betamethasone dipropionate) Foam This Instructions for Use contains information on how to apply Enstilar Foam. Important Information You Need to Know Before Applying Enstilar Foam: Enstilar Foam is for use on skin only (topical). Do not get Enstilar Foam near or in your mouth, eyes or vagina.

If you accidentally get Enstilar Foam on the face, in the mouth or in the eyes, wash the area with water right away. Do not swallow Enstilar Foam. Applying Enstilar Foam: Follow your healthcare provider's instructions on how much Enstilar Foam to use and where to use it.

Wash your hands before applying Enstilar Foam. Step 1 : Remove the cap from the can. Shake the can before use.

Step 2: Hold the can at least 1.5 inches from the affected area. Step 3: The foam can be sprayed holding the can in any position except sideways (horizontally). To spray, push down on the nozzle.

Note: Enstilar Foam will slowly become smaller in size after spraying. Step 4: Gently rub in Enstilar Foam into your affected skin area. Repeat the steps above to apply Enstilar Foam to other affected areas as instructed by your healthcare provider.

Step 5: After applying Enstilar Foam, put the cap back on the can. Step 6: Wash your hands after using Enstilar Foam unless you are using the medicine to treat your hands. Storing Enstilar Foam Store Enstilar Foam at room temperature between 68°F to 77°F (20°C to 25°C).

Do not expose Enstilar Foam to heat or store at temperatures above 120°F (49°C). Do not puncture or burn the Enstilar Foam can. Do not freeze Enstilar Foam.

Disposing of Enstilar Foam Enstilar Foam has an expiration date (exp.) marked on the can. Do not use after this date. Throw away (dispose of) unused Enstilar Foam 6 months after the can has been opened.

Keep Enstilar Foam and all medicines out of the reach of children. Manufactured by: LEO Laboratories Ltd. 285 Cashel Road Dublin 12, Ireland Distributed by: LEO Pharma Inc.

Madison, NJ 07940, USA Enstilar ® is a registered trademark of LEO Pharma A/S. © 2022, LEO Pharma Inc. All rights reserved. This Instructions for Use has been approved by the U.S.

Food and Drug Administration. Revised: 4/2022 Step 1 Step 2 Step 3 Step 4

📄 Package Label / Principal Display Panel 101 words ▾

PRINCIPAL DISPLAY PANEL - 60 gram Can Carton NDC 50222-302-60 Rx only Enstilar ® (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064% Shake before Use For Topical Use Only Not for oral, ophthalmic, or intravaginal use Net Wt. 60 gram LEO ® PRINCIPAL DISPLAY PANEL - 60 gram Can Carton

PRINCIPAL DISPLAY PANEL - 120 gram Can Carton NDC 50222-302-66 Rx only Enstilar ® (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064% Shake before Use For Topical Use Only Not for oral, ophthalmic, or intravaginal use Net Wt. 120 gram (2 cans of 60 gram) LEO ® PRINCIPAL DISPLAY PANEL - 120 gram Can Carton

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

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.
1 can50222-0302-60 987 Rx · $1,403,614
2 cans50222-0302-66 48 Rx · $114,006
1 can this page50222-0302-91 No Medicaid data
Drug total (last 4 qtrs): 1,035 Rx · 69,180 units · $1,517,620 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 Enstilar — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Enstilar. 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
$1.03M
Claims incl. refills
593
Beneficiaries
461
Spend / beneficiary
$2,237.19
Spend / claim
$1,739.20
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 ENSTILAR (this brand).

Top reported reactions

Psoriasis396
Diarrhoea136
Pruritus131
Headache109
Pain109
Fatigue91
Psoriatic Arthropathy89

Age at onset

Child1
Adolescent2
Adult368
Elderly116

Reporter sex

1,871 reports
Male · 47%
Female · 53%
Unknown · 0%

Serious outcomes

Hospitalization557
Death90
Life-threatening86
Disabling28
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 279 47
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.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

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.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by LEO Pharma Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 can (50222-0302-60), 2 cans (50222-0302-66). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
LEO Pharma Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 50222-0280-30 · LEO 50222-0303-50 · LEO →
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.