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ZORYVE roflumilast 3 mg/g Cream — NDC 80610-0130-60 package photo

ZORYVE roflumilast 3 mg/g Cream

by Arcutis Biotherapeutics, Inc. · 1 TUBE in 1 CARTON (80610-130-60) / 60 g in 1 TUBE
NDC 80610-0130-60
🏷️ FDA NDC (as labeled) 80610-130-60 billing pads the product segment with a zero
This package
Contains60 g in 1 tube Cost per g$15.38 NADAC Per package$922.79 / 60 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $14.91/unit · Part D plans $16.28/unit — full pricing hub ↓
Also comes in: 6 tubes 80610-0130-96
Rx only Brand On market Non-controlled
🗂️ Data synced Aug 13, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 80610-130-60
Product NDC 80610-130
11-digit billing NDC 80610013060
NCPDP billing unit GM — per gram (weight)
RxCUI 2608534, 2608539, 2687710, 2687712, 2725121, 2725123
UNII 0P6C6ZOP5U
Application # NDA215985
SPL Set ID ec1bb0d1-f38a-4080-831a-68791d1d1fdb
Established class (EPC) Phosphodiesterase 4 Inhibitor
Mechanism of action Phosphodiesterase 4 Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-07-29
Route TOPICAL
Dosage form CREAM
Substance ROFLUMILAST
GCN Seq No 083653
GCN 52657
HICL code 037123
Ingredient (HICL) Roflumilast
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5F
Therapeutic class — specific (HIC3) Antipsoriatics Agents
AHFS code 48:32.00.00
AHFS class Phosphodiesterase Type 4 Inhibitors
FDB label name ZORYVE 0.3% CREAM
FDB brand name Zoryve
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 80610-130-60 — 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 → 80610-0130-60. 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 Phosphodiesterase 4 Inhibitor class.

Pharmacologic class Phosphodiesterase 4 Inhibitor
Drug family (ATC) Other antipsoriatics for topical use, Other systemic drugs for obstructive airway diseases
How it works Phosphodiesterase 4 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerArcutis Biotherapeutics, Inc.
Application holderARCUTIS BIOTHERAPEUTICS INC
FDA applicationNDA215985 (NDA)
Labeler code80610
First marketedJul 2022
Product typeHuman Prescription Drug
Portfolio4 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name ZORYVE 0.3% CREAM Ingredient Roflumilast
📖 What it is MedlinePlus · NLM

Roflumilast is used in people with severe chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways) to reduce the number of episodes or worsening of COPD symptoms. Roflumilast is in a class of medications called phosphodiesterase inhibitors. It works by decreasing swelling in the lungs.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • That depends on the form you have. The tablet (sold as Daliresp or generic roflumilast) is used to help prevent flare-ups in people with severe COPD tied to chronic bronchitis — it...
  • No — and this is really important. Roflumilast tablets do not open up the airways, so they won't help during a sudden COPD flare or breathing emergency. You need a separate rescue...
  • Can I use the COPD tablet during a sudden breathing attack?
  • This is a real concern worth taking seriously. Roflumilast tablets have been linked to depression, anxiety, trouble sleeping, and in rare cases suicidal thoughts or behavior. It do...
📖 Read our full Roflumilast guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White / 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 099WOY1SA3
    A synthetic emulsifier and solubilizer derived from cetyl and stearyl alcohols. It helps blend oil and water-based ingredients together and improves how medicines dissolve or spread in formulations.
  • UNII 4O6GCK4CTJ
    A waxy substance derived from plant or animal oils that acts as an emulsifier and thickener. It helps blend water and oil ingredients together and gives the product a smooth, stable texture.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII A1A1I8X02B
    A clear liquid solvent derived from ethylene glycol. It helps dissolve active ingredients and improve how the medicine flows and mixes in liquid formulations.
  • UNII KEH0A3F75J
    Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable during storage.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 8CRQ2TH63M
    Isopropyl palmitate is an oily liquid derived from palm oil. It acts as an emollient and lubricant in medicines, helping soften the skin or improve how the product spreads and flows.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 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 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.
  • UNII B6E5W8RQJ4
    White petrolatum is a purified mineral oil product used as a lubricant and skin protectant in medications. It helps pills slide through manufacturing equipment and can soften or protect the skin when applied topically.

12 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.

💲 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 $15.380 $922.79 / 60 g
Medicaid paysCMS SDUD · 12 mo $14.91 $894.77 / 60 g
Medicare drug plans payPart D · Q2 2026 $16.28 $976.94 / 60 g
NADAC price history (per g) — tap or hover for the price & month
Nov 2023 Jan 2026 Jun 2026 Aug 2026 $15.390 $13.771
▲ Up 12% over the last 6 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zoryve 3 mg/gthis 80610-0130-60 Arcutis 1 tube $15.380 — Availability likely —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2024
First FDA approval
Jul 2024
📍
2026
Currently FDA-listed
2 years listed
🛡️
2037
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Aug 2037. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jul 9, 2024 RLD RS ⏳ ~10.9 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 11129818 — method of use (U-3712)
US 9907788 — method of use (U-3712)
US 9907788 — method of use (U-3408)
US 11129818 — method of use (U-3408)
US 12310956 — method of use (U-4301)
US 12005051 — method of use (U-3970)
US 11992480 — method of use (U-3970)
US 11819496 — method of use (U-3970)
US 11129818 — method of use (U-3970)
US 11992480 — method of use (U-4301)
US 11819496 — method of use (U-4301)
US 12005051 — method of use (U-4301)
US 11129818 — method of use (U-4301)
US 9907788 — method of use (U-4301)
US 12310956 — method of use (U-3748)
US 12310956 — method of use (U-3970)
US 11992480 — method of use (U-3748)
US 9907788 — method of use (U-3970)
US 11819496 — method of use (U-3748)
US 12005051 — method of use (U-3748)
US 12310956 — method of use (U-4578)
US 12005051 — method of use (U-4578)
US 11992480 — method of use (U-4578)
US 11819496 — method of use (U-4578)
US 11129818 — method of use (U-4578)
US 9907788 — method of use (U-4578)
US 10940142 — drug product
US 12257242 — drug product
US 12220409 — drug product
US 12042487 — drug product
US 12011437 — drug product
US 12005052 — drug product
US 12042487 — drug product
US 9884050 — drug product
US 12016848 — drug product
US 10940142 — drug product
US 12016848 — drug product
US 12220409 — drug product
US 12336983 — drug product
US 12011437 — drug product
US 10940142 — drug product
US 9884050 — drug product
US 12005052 — drug product
US 12042487 — drug product
US 12336983 — drug product
US 12005052 — drug product
US 11793796 — drug product
US 11793796 — drug product
US 12220409 — drug product
US 12336983 — drug product
US 12257242 — drug product
US 12257242 — drug product
US 12016848 — drug product
US 9884050 — drug product
US 12011437 — drug product
US 11793796 — drug product
Exclusivity NPP
Exclusivity NPP
Exclusivity NS
Exclusivity NS
2024 2026 2028 2030 2032 2034 2036
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 (56)
PatentTypeUse codeExpires
US 11129818 ↗ Method of use U-3712 Aug 25, 2037
US 9907788 ↗ Method of use U-3712 Jun 7, 2037
US 9907788 ↗ Method of use U-3408 Jun 7, 2037
US 11129818 ↗ Method of use U-3408 Aug 25, 2037
US 12310956 ↗ Method of use U-4301 Jun 7, 2037
US 12005051 ↗ Method of use U-3970 Jun 7, 2037
US 11992480 ↗ Method of use U-3970 Jun 7, 2037
US 11819496 ↗ Method of use U-3970 Jun 7, 2037
US 11129818 ↗ Method of use U-3970 Aug 25, 2037
US 11992480 ↗ Method of use U-4301 Jun 7, 2037
US 11819496 ↗ Method of use U-4301 Jun 7, 2037
US 12005051 ↗ Method of use U-4301 Jun 7, 2037
US 11129818 ↗ Method of use U-4301 Aug 25, 2037
US 9907788 ↗ Method of use U-4301 Jun 7, 2037
US 12310956 ↗ Method of use U-3748 Jun 7, 2037
US 12310956 ↗ Method of use U-3970 Jun 7, 2037
US 11992480 ↗ Method of use U-3748 Jun 7, 2037
US 9907788 ↗ Method of use U-3970 Jun 7, 2037
US 11819496 ↗ Method of use U-3748 Jun 7, 2037
US 12005051 ↗ Method of use U-3748 Jun 7, 2037
US 12310956 ↗ Method of use U-4578 Jun 7, 2037
US 12005051 ↗ Method of use U-4578 Jun 7, 2037
US 11992480 ↗ Method of use U-4578 Jun 7, 2037
US 11819496 ↗ Method of use U-4578 Jun 7, 2037
US 11129818 ↗ Method of use U-4578 Aug 25, 2037
US 9907788 ↗ Method of use U-4578 Jun 7, 2037
US 10940142 ↗ Drug product — Jun 7, 2037
US 12257242 ↗ Drug product — Jun 7, 2037
US 12220409 ↗ Drug product — Jun 7, 2037
US 12042487 ↗ Drug product — Jun 7, 2037
US 12011437 ↗ Drug product — Jun 7, 2037
US 12005052 ↗ Drug product — Jun 7, 2037
US 12042487 ↗ Drug product — Jun 7, 2037
US 9884050 ↗ Drug product — Jun 7, 2037
US 12016848 ↗ Drug product — Jun 7, 2037
US 10940142 ↗ Drug product — Jun 7, 2037
US 12016848 ↗ Drug product — Jun 7, 2037
US 12220409 ↗ Drug product — Jun 7, 2037
US 12336983 ↗ Drug product — Jun 7, 2037
US 12011437 ↗ Drug product — Jun 7, 2037
US 10940142 ↗ Drug product — Jun 7, 2037
US 9884050 ↗ Drug product — Jun 7, 2037
US 12005052 ↗ Drug product — Jun 7, 2037
US 12042487 ↗ Drug product — Jun 7, 2037
US 12336983 ↗ Drug product — Jun 7, 2037
US 12005052 ↗ Drug product — Jun 7, 2037
US 11793796 ↗ Drug product — Jun 7, 2037
US 11793796 ↗ Drug product — Jun 7, 2037
US 12220409 ↗ Drug product — Jun 7, 2037
US 12336983 ↗ Drug product — Jun 7, 2037
US 12257242 ↗ Drug product — Jun 7, 2037
US 12257242 ↗ Drug product — Jun 7, 2037
US 12016848 ↗ Drug product — Jun 7, 2037
US 9884050 ↗ Drug product — Jun 7, 2037
US 12011437 ↗ Drug product — Jun 7, 2037
US 11793796 ↗ Drug product — Jun 7, 2037
FDA exclusivity
CodeWhat it grantsExpires
NPPNew Patient PopulationJun 29, 2029
NPPNew Patient PopulationOct 5, 2026
NSNew StrengthJul 9, 2027
NSNew StrengthOct 4, 2028
Common questions
Is there a generic version of ZORYVE 0.3% CREAM?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for ZORYVE 0.3% CREAM. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Aug 2037 — an estimate, not a guaranteed launch date.
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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 80610-0130-60, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
30.7K
Units reimbursed last 4 qtrs
1.8M
Gross reimbursed last 4 qtrs
$27.46M
Avg / prescription
$895.46
Avg / unit
$14.9128
Latest quarter Q4 2025
9.3KRx
Medicaid pays / g
$14.9128
gross reimbursed
vs
NADAC / g
$15.3798
acquisition cost
=
Spread
−$0.4670
-3% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
79% FFS 21% MCO
Fee-for-service · 24,322 Rx Managed care · 6,344 Rx
State Medicaid map
Alaska: 780 units · 106 per 100k residents AK Maine: no data reported ME Washington: 12,240 units · 157 per 100k residents WA Idaho: 1,500 units · 76.4 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 4,320 units · 75.3 per 100k residents MN Wisconsin: 15,360 units · 260 per 100k residents WI Michigan: 14,580 units · 145 per 100k residents MI New York: 431,525 units · 2,205 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 8,010 units · 251 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 9,240 units · 288 per 100k residents IA Illinois: 12,959 units · 103 per 100k residents IL Indiana: 9,780 units · 143 per 100k residents IN Ohio: 36,960 units · 314 per 100k residents OH Pennsylvania: 24,720 units · 191 per 100k residents PA New Jersey: 23,460 units · 253 per 100k residents NJ Massachusetts: 34,680 units · 495 per 100k residents MA California: 968,626 units · 2,486 per 100k residents CA Utah: no data reported UT Colorado: 5,280 units · 89.8 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 13,620 units · 301 per 100k residents KY West Virginia: no data reported WV Virginia: 27,060 units · 310 per 100k residents VA Maryland: 19,740 units · 319 per 100k residents MD Connecticut: 22,260 units · 615 per 100k residents CT Rhode Island: 10,560 units · 964 per 100k residents RI Arizona: 7,980 units · 107 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 6,000 units · 84.2 per 100k residents TN North Carolina: 15,120 units · 140 per 100k residents NC South Carolina: 1,320 units · 24.6 per 100k residents SC Delaware: 2,580 units · 250 per 100k residents DE Oklahoma: 4,980 units · 123 per 100k residents OK Louisiana: 21,930 units · 479 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 4,080 units · 37.0 per 100k residents GA D.C.: 720 units · 106 per 100k residents DC Hawaii: 1,680 units · 117 per 100k residents HI Texas: 27,840 units · 91.3 per 100k residents TX Florida: 39,900 units · 176 per 100k residents FL
Units reimbursed · per 100k residents
24.62,486
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 California 2,486 /100k
2 New York 2,205 /100k
3 Rhode Island 964 /100k
4 Connecticut 615 /100k
5 Massachusetts 495 /100k
6 Louisiana 479 /100k
7 Maryland 319 /100k
8 Ohio 314 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 tube this page80610-0130-60 34,470 Rx · $31,140,415
6 tubes80610-0130-96 No Medicaid data
Drug total (last 4 qtrs): 34,470 Rx · 2,067,725 units · $31,140,415 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 Zoryve — 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 Zoryve. 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
$18.64M
Claims incl. refills
19.5K
Beneficiaries
14K
Spend / beneficiary
$1,333.82
Spend / claim
$956.07
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 ZORYVE (this brand).

Top reported reactions

Dyspnoea453
Chronic Obstructive Pulmonary Disease241
Diarrhoea226
Pneumonia221
Asthma212
Cough197
Nausea175

Age at onset

Child19
Adolescent18
Adult326
Elderly318

Reporter sex

0 reports
Male · 50%
Female · 50%
Unknown · 0%

Serious outcomes

Hospitalization1,039
Death194
Life-threatening79
Disabling32
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 648 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
80610-0130-60 You're viewing this 1 TUBE in 1 CARTON (80610-130-60) / 60 g in 1 TUBE $15.38 / g $922.79 2022-07-29 Active
80610-0130-96 6 TUBE in 1 CARTON (80610-130-96) / 5 g in 1 TUBE (80610-130-05) — — 2022-07-29 Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 80610-0130-60?
NDC 80610-0130-60 is listed by the FDA — 1 tube in 1 carton / 60 g in 1 tube.
What NDC number is used to bill for this package of ZORYVE roflumilast 3 mg/g Cream?
Bill NDC 80610-0130-60 — the 11-digit billing format is 80610013060. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications 🤒 Adverse Reactions 🔄 Drug Interactions 👥 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
🎯 Indications and Usage 180 words ▾

1 INDICATIONS AND USAGE ZORYVE cream is a phosphodiesterase 4 inhibitor: Plaque Psoriasis ZORYVE cream, 0.3%, is indicated for the topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 2 years of age and older. ( 1.1 ) Atopic Dermatitis ZORYVE cream, 0.15%, is indicated for the topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. ( 1.2 ) ZORYVE cream, 0.05%, is indicated for the topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age.

( 1.2 )

1.1Plaque Psoriasis ZORYVE ® cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 2 years of age and older.

1.2Atopic Dermatitis ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. ZORYVE cream, 0.05%, is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age.

⏱️ Dosage and Administration 183 words ▾

2 DOSAGE AND ADMINISTRATION Plaque Psoriasis Use ZORYVE cream, 0.3%, for the treatment of plaque psoriasis in adult and pediatric patients 2 years of age and older. Atopic Dermatitis Use ZORYVE cream, 0.15%, for the treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. Use ZORYVE cream, 0.05%, for the treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age.

Administration Instructions Apply ZORYVE cream to affected areas once daily and rub in completely. Wash hands after application. ZORYVE cream is for topical use only and not for ophthalmic, oral, or intravaginal use.

For topical use only. ( 2 ) Not for ophthalmic, oral, or intravaginal use. ( 2 ) Plaque Psoriasis Apply ZORYVE cream, 0.3%, once daily to affected areas.

( 2 ) Atopic Dermatitis Adult and Pediatric Patients 6 Years of Age and Older Apply ZORYVE cream, 0.15%, once daily to affected areas. ( 2 ) Pediatric Patients 2 to 5 Years of Age Apply ZORYVE cream, 0.05%, once daily to affected areas. ( 2 )

💊 Dosage Forms and Strengths 95 words ▾

3 DOSAGE FORMS AND STRENGTHS Cream, 0.3%: 3 mg of roflumilast per gram of white to off-white cream in 60-gram tubes. Cream, 0.15%: 1.5 mg of roflumilast per gram of white to off-white cream in 60-gram tubes. Cream, 0.05%: 0.5 mg of roflumilast per gram of white to off-white cream in 60-gram tubes.

Cream, 0.3%: 3 mg of roflumilast per gram in 60-gram tubes. ( 3 ) Cream, 0.15%: 1.5 mg of roflumilast per gram in 60-gram tubes. ( 3 ) Cream, 0.05%: 0.5 mg of roflumilast per gram in 60-gram tubes.

( 3 )

⛔ Contraindications 42 words ▾

4 CONTRAINDICATIONS ZORYVE cream is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C) [see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ] . Moderate to severe liver impairment (Child-Pugh B or C). ( 4 )

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (reported in ≥1% of subjects) are: Plaque Psoriasis: diarrhea, headache, insomnia, nausea, application site pain, upper respiratory tract infection, and urinary tract infection. ( 6.1 ) Atopic Dermatitis: headache, nausea, application site pain, diarrhea, vomiting, upper respiratory tract infection, rhinitis, and conjunctivitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Arcutis Biotherapeutics, Inc. at 1-844-692-6729 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. Plaque Psoriasis Adult and Pediatric Subjects 6 Years of Age and Older In two multicenter, randomized, double-blind, vehicle-controlled trials (DERMIS-1 and DERMIS-2), 881 adult and pediatric subjects 6 years of age or older with plaque psoriasis were treated with ZORYVE cream, 0.3%, or vehicle cream once daily for 8 weeks [see Clinical Studies (14.1) ] .

The proportion of subjects who discontinued treatment due to an adverse reaction was 1.0% for subjects treated with ZORYVE cream, 0.3%, and 1.3% for subjects treated with vehicle cream. The most common adverse reaction that led to discontinuation of ZORYVE cream, 0.3%, was application site urticaria (0.3%). Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with ZORYVE cream, 0.3%, and for which the rate exceeded the rate for vehicle cream.

Table 1: Adverse Reactions Reported in ≥1% of Adult and Pediatric Subjects 6 Years of Age and Older with Plaque Psoriasis Treated with ZORYVE Cream, 0.3%, (and More Frequently than Vehicle Cream) for 8 Weeks in Trials DERMIS-1 and DERMIS-2 Adverse Reaction ZORYVE Cream, 0.3% (N=576) n (%) Vehicle Cream (N=305) n (%) Diarrhea 18 (3.1) 0 (0.0) Headache 14 (2.4) 3 (1.0) Insomnia 8 (1.4) 2 (0.7) Nausea 7 (1.2) 1 (0.3) Application site pain 6 (1.0) 1 (0.3) Upper respiratory tract infection 6 (1.0) 1 (0.3) Urinary tract infection 6 (1.0) 2 (0.7) In 644 subjects 6 years of age and older with plaque psoriasis who continued treatment with ZORYVE cream, 0.3%, for up to 64 weeks in open-label extension trials, the adverse reaction profile was consistent with that observed in vehicle-controlled trials.

Pediatric Subjects 2 to 5 Years of Age The safety of ZORYVE cream, 0.3%, once daily was assessed in an open-label trial for up to 24 weeks. The adverse reaction profile in pediatric subjects 2 years to 5 years of age with plaque psoriasis was consistent with that observed in adult and pediatric subjects 6 years of age and older. Atopic Dermatitis Adult and Pediatric Subjects 6 Years of Age and Older In two multicenter, randomized, double-blind, vehicle-controlled trials (INTEGUMENT-1 and INTEGUMENT-2), 1336 adult and pediatric subjects 6 years of age or older with mild to moderate atopic dermatitis were treated with ZORYVE cream, 0.15%, or vehicle cream once daily for 4 weeks [see Clinical Studies (14.2) ] .

The proportion of subjects who discontinued treatment due to an adverse reaction was 1.6% for subjects treated with ZORYVE cream, 0.15%, and 1.1% for subjects treated with vehicle cream. Table 2 presents adverse reactions that occurred in at least 1% of subjects treated with ZORYVE cream, 0.15%, and for which the rate exceeded the rate for vehicle cream. Table 2: Adverse Reactions Reported in ≥1% of Adult and Pediatric Subjects 6 Years of Age and Older with Atopic Dermatitis Treated with ZORYVE Cream, 0.15%, (and More Frequently than Vehicle Cream) for 4 Weeks in Trials INTEGUMENT-1 and INTEGUMENT-2 Adverse Reaction ZORYVE Cream, 0.15% (N=885) n (%) Vehicle Cream (N=451) n (%) Headache 26 (2.9) 4 (0.9) Nausea 17 (1.9) 2 (0.4) Application site pain 13 (1.5) 3 (0.7) Diarrhea 13 (1.5) 2 (0.4) Vomiting 1…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Co-administration of roflumilast with systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously may increase roflumilast systemic exposure and may result in increased adverse reactions. If these products are co-administered with ZORYVE cream, weigh the potential for increased adverse reactions against benefit. ( 7.1 ) Co-administration of roflumilast with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast systemic exposure and may result in increased adverse reactions.

If these products are co-administered with ZORYVE cream, weigh the potential for increased adverse reactions against benefit. ( 7.1 )

7.1Effects of Other Drugs on ZORYVE Cream Drugs that Inhibit Cytochrome P450 (CYP) Enzymes No formal drug-drug interaction studies were conducted with ZORYVE cream; however, the co-administration of roflumilast with systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously may increase roflumilast systemic exposure and may result in increased adverse reactions. If these products are co-administered with ZORYVE cream, weigh the potential for increased adverse reactions against benefit [see Clinical Pharmacology (12.3) ] .

Oral Contraceptives Containing Gestodene and Ethinyl Estradiol The co-administration of roflumilast with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast systemic exposure and may result in increased adverse reactions. If these products are co-administered with ZORYVE cream, weigh the potential for increased adverse reactions against benefit [see Clinical Pharmacology (12.3) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are insufficient data available on the use of ZORYVE cream in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, roflumilast administered orally to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities at doses up to 36 and 31 times the maximum recommended human dose (MRHD), respectively. Roflumilast induced post-implantation loss in rats at oral doses greater than or equal to 12 times the MRHD.

Roflumilast induced stillbirth and decreased pup viability in mice at oral doses 19 and 59 times the MRHD, respectively. Roflumilast has been shown to adversely affect pup post-natal development when dams were treated with an oral dose 59 times the MRHD during pregnancy and lactation periods in mice ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown.

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. Clinical Considerations Labor or Delivery Avoid using ZORYVE cream during labor and delivery. There are no human studies that have investigated effects of ZORYVE cream on preterm labor or labor at term; however, animal studies showed that oral roflumilast disrupted the labor and delivery process in mice.

Data Animal Data In an embryo-fetal development study, pregnant rats were dosed orally during the period of organogenesis with up to 1.8 mg/kg/day roflumilast (36 times the MRHD on a mg/m 2 basis). No evidence of structural abnormalities or effects on survival rates were observed. Roflumilast did not affect embryo-fetal development at a maternal oral dose of 0.2 mg/kg/day (4 times the MRHD on a mg/m 2 basis).

In a fertility and embryo-fetal development study, male rats were dosed orally with up to 1.8 mg/kg/day roflumilast for 10 weeks and females for 2 weeks prior to pairing and throughout the organogenesis period. Roflumilast induced pre- and post-implantation loss at maternal oral doses greater than or equal to 0.6 mg/kg/day (12 times the MRHD on a mg/m 2 basis). Roflumilast did not cause fetal structural abnormalities at maternal oral doses up to 1.8 mg/kg/day (35 times the MRHD on a mg/m 2 basis).

In an embryo-fetal development study in rabbits, pregnant does were dosed orally with 0.8 mg/kg/day roflumilast during the period of organogenesis. Roflumilast did not cause fetal structural abnormalities at the maternal oral doses of 0.8 mg/kg/day (31 times the MRHD on a mg/m 2 basis). In pre- and post-natal developmental studies in mice, dams were dosed orally with up to 12 mg/kg/day roflumilast during the period of organogenesis and lactation.

Roflumilast induced stillbirth and decreased pup viability at maternal oral doses greater than 2 mg/kg/day and 6 mg/kg/day, respectively (19 and 59 times the MRHD on a mg/m 2 basis, respectively). Roflumilast induced delivery retardation in pregnant mice at maternal oral doses greater than 2 mg/kg/day (19 times the MRHD on a mg/m 2 basis). Roflumilast decreased pup rearing frequencies at a maternal oral dose of 6 mg/kg/day during pregnancy and lactation (59 times the MRHD on a mg/m 2 basis).

Roflumilast also decreased survival and forelimb grip reflex and delayed pinna detachment in mouse pups at a maternal oral dose of 12 mg/kg/day (116 times the MRHD on a mg/m 2 basis).

8.2Lactation Risk Summary There are no data on the presence of roflumilast or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production. Roflumilast and/or its metabolites are excreted into the milk of lactating rats ( see Data ). When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding s…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary There are insufficient data available on the use of ZORYVE cream in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, roflumilast administered orally to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities at doses up to 36 and 31 times the maximum recommended human dose (MRHD), respectively. Roflumilast induced post-implantation loss in rats at oral doses greater than or equal to 12 times the MRHD.

Roflumilast induced stillbirth and decreased pup viability in mice at oral doses 19 and 59 times the MRHD, respectively. Roflumilast has been shown to adversely affect pup post-natal development when dams were treated with an oral dose 59 times the MRHD during pregnancy and lactation periods in mice ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown.

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. Clinical Considerations Labor or Delivery Avoid using ZORYVE cream during labor and delivery. There are no human studies that have investigated effects of ZORYVE cream on preterm labor or labor at term; however, animal studies showed that oral roflumilast disrupted the labor and delivery process in mice.

Data Animal Data In an embryo-fetal development study, pregnant rats were dosed orally during the period of organogenesis with up to 1.8 mg/kg/day roflumilast (36 times the MRHD on a mg/m 2 basis). No evidence of structural abnormalities or effects on survival rates were observed. Roflumilast did not affect embryo-fetal development at a maternal oral dose of 0.2 mg/kg/day (4 times the MRHD on a mg/m 2 basis).

In a fertility and embryo-fetal development study, male rats were dosed orally with up to 1.8 mg/kg/day roflumilast for 10 weeks and females for 2 weeks prior to pairing and throughout the organogenesis period. Roflumilast induced pre- and post-implantation loss at maternal oral doses greater than or equal to 0.6 mg/kg/day (12 times the MRHD on a mg/m 2 basis). Roflumilast did not cause fetal structural abnormalities at maternal oral doses up to 1.8 mg/kg/day (35 times the MRHD on a mg/m 2 basis).

In an embryo-fetal development study in rabbits, pregnant does were dosed orally with 0.8 mg/kg/day roflumilast during the period of organogenesis. Roflumilast did not cause fetal structural abnormalities at the maternal oral doses of 0.8 mg/kg/day (31 times the MRHD on a mg/m 2 basis). In pre- and post-natal developmental studies in mice, dams were dosed orally with up to 12 mg/kg/day roflumilast during the period of organogenesis and lactation.

Roflumilast induced stillbirth and decreased pup viability at maternal oral doses greater than 2 mg/kg/day and 6 mg/kg/day, respectively (19 and 59 times the MRHD on a mg/m 2 basis, respectively). Roflumilast induced delivery retardation in pregnant mice at maternal oral doses greater than 2 mg/kg/day (19 times the MRHD on a mg/m 2 basis). Roflumilast decreased pup rearing frequencies at a maternal oral dose of 6 mg/kg/day during pregnancy and lactation (59 times the MRHD on a mg/m 2 basis).

Roflumilast also decreased survival and forelimb grip reflex and delayed pinna detachment in mouse pups at a maternal oral dose of 12 mg/kg/day (116 times the MRHD on a mg/m 2 basis).

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use Plaque Psoriasis The safety and effectiveness of ZORYVE cream, 0.3%, for the topical treatment of plaque psoriasis, including intertriginous areas, have been established in pediatric patients 2 years of age and older. Use of ZORYVE cream, 0.3%, for this indication is supported by data from: Two 8-week, vehicle-controlled, safety and efficacy trials in adults and 18 subjects 6 to 17 years of age, of whom 11 received ZORYVE cream, 0.3%; One open-label, safety trial in 21 pediatric subjects 2 to 5 years of age with up to 25% BSA involvement who applied ZORYVE cream, 0.3%, up to 24 weeks; With additional safety and pharmacokinetic (PK) data from: Open-label trials of 2- and 24-weeks duration which included 25 subjects 12 to 17 years of age treated with ZORYVE cream, 0.3%; Two 4-week, open-label, safety and PK studies which included 20 pediatric subjects 6 to 11 years of age and 10 pediatric subjects 2 to 5 years of age, treated with ZORYVE cream, 0.3% [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , Clinical Studies (14.1) ] .

The safety and effectiveness of ZORYVE cream, 0.3%, have not been established in pediatric patients younger than 2 years of age. Atopic Dermatitis ZORYVE Cream, 0.15% The safety and effectiveness of ZORYVE cream, 0.15%, for the topical treatment of mild to moderate atopic dermatitis have been established in pediatric patients 6 years of age and older. Use of ZORYVE cream, 0.15%, in this age group is supported by data from two 4-week, vehicle-controlled, safety and efficacy trials which included 615 subjects 6 to 17 years of age, of whom 406 received ZORYVE cream, 0.15%, [see Clinical Pharmacology (12.3) , Clinical Studies (14.2) ] .

Use of ZORYVE cream, 0.15%, in pediatric patients 6 years of age and older is also supported by data from 481 pediatric subjects treated with ZORYVE cream, 0.15%, in open-label trials, of which 104 were treated for 52 weeks. In an open-label PK trial in 36 pediatric subjects 2 to 16 years of age, following topical administration of roflumilast cream, 0.15%, once daily for 2 weeks, mean systemic exposure of roflumilast and roflumilast N-oxide in subjects 2 to 5 years of age was approximately 3.2-fold and 5.2-fold higher, respectively, compared to subjects 12 to 16 years of age, and approximately 2-fold and 2.3-fold higher, respectively, compared to subjects 6 to 11 years of age.

The safety and effectiveness of ZORYVE cream, 0.15%, have not been established in pediatric patients younger than 6 years of age. ZORYVE Cream, 0.05% The safety and effectiveness of ZORYVE cream, 0.05%, for the topical treatment of mild to moderate atopic dermatitis have been established in pediatric patients 2 to 5 years of age. Use of ZORYVE cream, 0.05%, in this age group is supported by data from one 4-week, vehicle-controlled, safety and efficacy trial which included 652 subjects 2 to 5 years of age, of whom 437 received ZORYVE cream, 0.05%, [see Clinical Pharmacology (12.3) , Clinical Studies (14.2) ] .

Use of ZORYVE cream, 0.05%, in pediatric patients 2 to 5 years of age is also supported by data from 572 pediatric subjects treated with ZORYVE cream, 0.05%, in open-label trials, of whom 353 were treated for 52 weeks. The safety and effectiveness of ZORYVE cream, 0.05%, have not been established in pediatric patients younger than 2 years of age and older than 6 years of age.

🧓 Geriatric Use 192 words ▾

8.5Geriatric Use There were 184 patients 65 years of age and older in clinical studies for plaque psoriasis and atopic dermatitis [see Clinical Studies (14.1 , 14.2) ] . Plaque Psoriasis Of the 576 patients treated with ZORYVE cream, 0.3%, in the 2 controlled clinical studies for plaque psoriasis, 56 (9.7%) were 65 to 74 years of age and 21 (3.7%) were 75 years of age and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

Other reported clinical experience has not identified differences in responses between the geriatric and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Atopic Dermatitis Of the 885 patients treated with ZORYVE cream, 0.15%, in the 2 controlled clinical studies for atopic dermatitis, 36 (4.1%) were 65 to 74 years of age and 8 (0.9%) were 75 years of age and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

Other reported clinical experience has not identified differences in responses between the geriatric 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 Roflumilast and its active metabolite (roflumilast N-oxide) are inhibitors of PDE4. Roflumilast and roflumilast N-oxide inhibition of PDE4 (a major cyclic 3′,5′-adenosine monophosphate [cyclic AMP] metabolizing enzyme) activity leads to accumulation of intracellular cyclic AMP. The specific mechanism(s) by which roflumilast exerts its therapeutic action is not well defined.

12.2Pharmacodynamics Pharmacodynamics of ZORYVE cream in the treatment of plaque psoriasis and atopic dermatitis are unknown.

12.3Pharmacokinetics Absorption Following application of ZORYVE cream, the plasma concentration versus time profile was relatively flat, generally with a peak-to-trough ratio less than 2. Plaque Psoriasis The PK of ZORYVE cream, 0.3%, was assessed in 18 adult and 6 pediatric subjects 13 to 16 years of age with plaque psoriasis and a mean ± SD body surface area (BSA) involvement of 26.8 ± 6.80% and 13.0 ± 3.58% in adult and pediatric subjects, respectively. In this study, on average, subjects applied 3 to 6.5 g of ZORYVE cream, 0.3%, once daily for 15 days.

Plasma concentrations of roflumilast and roflumilast N-oxide (see Metabolism ) were quantifiable in all but two subjects at Day 15. In adults, the mean ± SD systemic exposure (AUC 0-24 ) was 72.7 ± 53.1 and 628 ± 648 h∙ng/mL for roflumilast and the N-oxide metabolite, respectively. In pediatric subjects (13 to 16 years of age), the mean ± SD AUC 0-24 was 25.1 ± 24.0 and 140 ± 179 h∙ng/mL for roflumilast and the N-oxide metabolite, respectively.

The PK of ZORYVE cream, 0.3%, was assessed in 10 pediatric subjects (6 to 11 years of age) with at least mild plaque psoriasis and a mean ± SD BSA involvement of 10.9 ± 6.56%. The 14-day mean ± SD extrapolated AUC 0-24 was 75.6 ± 87.3 and 693 ± 986 h∙ng/mL for roflumilast and the N-oxide metabolite, respectively. In another study, the PK of ZORYVE cream, 0.3%, was assessed in 9 pediatric subjects (2 to 5 years of age) with at least mild plaque psoriasis and a mean ± SD BSA involvement of 9.44 ± 5.57%.

The 14-day mean ± SD extrapolated AUC 0-24 was 51.6 ± 29.9 and 539 ± 372 h∙ng/mL for roflumilast and the N-oxide metabolite, respectively. Atopic Dermatitis The PK of ZORYVE cream, 0.15%, was assessed in 12 pediatric subjects 12 to 16 years of age and 13 pediatric subjects 6 to 11 years of age with atopic dermatitis and a mean ± SD BSA involvement of 33.7 ± 14.8% and 43.5 ± 10.5%, respectively. On average, subjects applied 8.2 to 10.5 g of ZORYVE cream, 0.15%, once daily.

In pediatric subjects 12 to 16 years of age, the Day 14 mean ± SD systemic exposure (AUC 0-24 ) was 62.9 ± 53.0 and 336 ± 310 h∙ng/mL for roflumilast and the N-oxide metabolite, respectively. In pediatric subjects 6 to 11 years of age, the Day 14 mean ± SD AUC 0-24 was 102 ± 96.5 and 743 ± 710 h∙ng/mL for roflumilast and the N-oxide metabolite, respectively. The PK of ZORYVE cream, 0.05%, was assessed in 9 pediatric subjects 2 to 5 years of age with atopic dermatitis and a mean ± SD BSA involvement of 42.4 ± 6.21%.

On average, subjects applied 5.2 g of ZORYVE cream, 0.05%, once daily. In pediatric subjects 2 to 5 years of age, the Day 14 mean ± SD systemic exposure (AUC 0-24 ) was 47.2 ± 27.4 and 338 ± 280 h∙ng/mL for roflumilast and the N-oxide metabolite, respectively. Distribution Plasma protein binding of roflumilast and its N-oxide metabolite is approximately 99% and 97%, respectively.

Elimination The plasma clearance after short-term intravenous infusion of roflumilast is on average about

9.6L/h. Following topical administration, the half-lives of roflumilast and the N-oxide metabolite were 4.0 and 4.6 days, respectively. Metabolism Roflumilast is extensively metabolized via Phase I (cytochrome P450) and Phase II (conjugation) reactions. The N-oxide metabolite is the only major metabolite observed in the plasma of humans. Following oral administration, roflumilast and roflumilast N-oxide account for the majority (87.5%…

🧬 Mechanism of Action 53 words ▾

12.1Mechanism of Action Roflumilast and its active metabolite (roflumilast N-oxide) are inhibitors of PDE4. Roflumilast and roflumilast N-oxide inhibition of PDE4 (a major cyclic 3′,5′-adenosine monophosphate [cyclic AMP] metabolizing enzyme) activity leads to accumulation of intracellular cyclic AMP. The specific mechanism(s) by which roflumilast exerts its therapeutic action is not well defined.

📦 How Supplied / Storage and Handling 89 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ZORYVE (roflumilast) cream is a white to off-white cream supplied as follows: Cream, 0.3%: 3 mg of roflumilast per gram supplied in 60-gram aluminum tubes (NDC 80610-130-60). Cream, 0.15%: 1.5 mg of roflumilast per gram supplied in 60-gram aluminum tubes (NDC 80610-115-60). Cream, 0.05%: 0.5 mg of roflumilast per gram supplied in 60-gram aluminum tubes (NDC 80610-105-60).

Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature]

📦 Storage and Handling 25 words ▾

Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature]

📋 Description 135 words ▾

11 DESCRIPTION ZORYVE (roflumilast) cream is a white to off-white cream for topical use. The active ingredient, roflumilast, is a phosphodiesterase 4 (PDE4) inhibitor. Roflumilast is described chemically as 3-cyclopropylmethoxy- N -(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide.

The empirical formula is C 17 H 14 Cl 2 F 2 N 2 O 3, and the molecular weight is 403.21. The structural formula is represented below: Roflumilast is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone. Each gram of cream, 0.05%, 0.15%, or 0.3%, contains 0.5 mg, 1.5 mg, or 3 mg of roflumilast, respectively, in a cream base containing ceteareth-10 phosphate, cetearyl phosphate, cetostearyl alcohol, diethylene glycol monoethyl ether, hexylene glycol, isopropyl palmitate, methylparaben, propylparaben, purified water, sodium hydroxide, and white petrolatum.

Hydrochloric acid may have been added to adjust pH. Chemical Structure

💬 Information for Patients 116 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling (Patient Information). Administration Instructions Advise patients or caregivers that ZORYVE cream is for topical use only and is not for ophthalmic, oral, or intravaginal use. Instruct patients and caregivers to wash hands after applying ZORYVE cream.

Lactation Advise the patient to use ZORYVE cream on the smallest area of skin and for the shortest duration possible while breastfeeding. Instruct the patient who is breastfeeding not to apply ZORYVE cream directly to the nipple or areola to avoid direct infant exposure. Instruct the patient to avoid inadvertent contact of treated areas with infant skin [see Use in Specific Populations (8.2) ] .

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