NDC 50222-0280-30 — Anzupgo delgocitinib 20 mg/g Cream

🆔 Identity & classification

FDA NDC (as labeled) 50222-280-30

Product NDC 50222-280

11-digit billing NDC 50222028030

NCPDP billing unit GM — per gram (weight)

RxCUI 2721167, 2721172

UNII 9L0Q8KK220

Application # NDA219155

SPL Set ID a59bf36e-6f04-4b47-b385-8040c95f040c

Established class (EPC) Janus Kinase Inhibitor

Mechanism of action Janus Kinase Inhibitors

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2025-07-24

Route TOPICAL

Dosage form CREAM

Substance DELGOCITINIB

GPI-14 90272020003720

GCN Seq No 087150

GCN 56998

HICL code 050242

Ingredient (HICL) Delgocitinib

HIC1 code Q

Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other

HIC2 code Q5

Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin

HIC3 code Q51

Therapeutic class — specific (HIC3) Topical Janus Kinase (Jak) Inhibitors

AHFS code 84:06.16.00

AHFS class Janus Kinase Inhibitors (84:06)

FDB label name ANZUPGO 2% CREAM

FDB brand name Anzupgo

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 50222-280-30 — 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 → 50222-0280-30. 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 Agents for dermatitis, excluding corticosteroids class.

Drug family (ATC) Agents for dermatitis, excluding corticosteroids

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

LabelerLEO Pharma, Inc

Application holderLEO PHARMA AS

FDA applicationNDA219155 (NDA)

Labeler code50222

First marketedJul 2025

Product typeHuman Prescription Drug

🔎 All NDCs from LEO Pharma, Inc

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 ANZUPGO 2% CREAM Ingredient Delgocitinib

📖 What it is MedlinePlus · NLM

Delgocitinib topical is used to treat certain types of chronic hand eczema (CHE; ongoing condition causing itching, dryness, scaling and redness of the skin of hands and wrists). Delgocitinib is in a class of medications called kinase inhibitors. How it works to help symptoms of CHE is unknown.

Read the full MedlinePlus article ↗

Patient education

📘 MedlinePlus patient leaflet ↗

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.

🧪 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 LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
UNII REK4960K2U
Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
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 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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 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 YRC528SWUY
A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
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.

9 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 system	Per g	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	$66.37	$1,991.16 / 30 g
Medicare drug plans payPart D · Q2 2026	$64.61	$1,938.22 / 30 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Anzupgo 20 mg/gthis 50222-0280-30	LEO	1 tube	—	—	FDA listed	—

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

🏛️

2025

First FDA approval

Jul 2025

📍

2026

Currently FDA-listed

1 year listed

🛡️

2031

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 Sep 2031. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.

📅 FDA approved Jul 23, 2025 RLD RS ⏳ ~5 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 8609647 — drug substance (U-4237)

Exclusivity NCE

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 (1)

Patent	Type	Use code	Expires
US 8609647 ↗	Drug substance	U-4237	Sep 19, 2031

FDA exclusivity

Code	What it grants	Expires
NCE	New Chemical Entity (5-year)	Jul 23, 2030

Common questions

Is there a generic version of ANZUPGO 2% CREAM?

No FDA-approved generic equivalent is currently listed in the FDA Orange Book for ANZUPGO 2% CREAM. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Sep 2031 — 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 50222-0280-30, 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.

📅 Q3 2025 – Q1 2026 · 3 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

876

Units reimbursed last 4 qtrs

28.1K

Gross reimbursed last 4 qtrs

$1.87M

Avg / prescription

$2,129.81

Avg / unit

$66.3720

Latest quarter Q1 2026

556Rx

Fee-for-service vs managed care ⓘ

58% FFS 42% MCO

Fee-for-service · 510 Rx Managed care · 366 Rx

State Medicaid map

Units reimbursed · per 100k residents

3.675.5

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 Connecticut 75.5 /100k

2 Hawaii 50.2 /100k

3 Louisiana 48.5 /100k

4 New York 32.7 /100k

5 Kentucky 21.2 /100k

6 Virginia 20.7 /100k

7 Nevada 19.7 /100k

8 California 17.4 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

1 tube this page50222-0280-30 876 Rx · $1,865,717

1 tube50222-0280-91 No Medicaid data

1 tube50222-0280-99 No Medicaid data

Drug total (last 4 qtrs): 876 Rx · 28,110 units · $1,865,717 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 Anzupgo — 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 Anzupgo. 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

$1.89M

Claims incl. refills

940

Beneficiaries

621

Spend / beneficiary

$3,040.87

Spend / claim

$2,008.92

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 Anzupgo (this brand).

Top reported reactions

Pruritus26

Dermatitis Atopic25

Dermatitis20

Erythema20

Rash14

Eczema11

Skin Burning Sensation10

Age at onset

Child1

Adolescent2

Adult32

Elderly14

Reporter sex

Male · 40%

Female · 60%

Serious outcomes

Hospitalization35

Life-threatening2

Death2

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
50222-0280-30 You're viewing this	1 TUBE in 1 CARTON (50222-280-30) / 30 g in 1 TUBE	2025-07-24	Active
50222-0280-91	1 TUBE in 1 CARTON (50222-280-91) / 15 g in 1 TUBE	2025-07-24	Active
50222-0280-99	1 TUBE in 1 CARTON (50222-280-99) / 5 g in 1 TUBE	2025-08-30	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 50222-0280-30?

NDC 50222-0280-30 is listed by the FDA — 1 tube in 1 carton / 30 g in 1 tube.

What NDC number is used to bill for this package of Anzupgo delgocitinib 20 mg/g Cream?

Bill NDC 50222-0280-30 — the 11-digit billing format is 50222028030. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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)	✓ Available

“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 FDA registers it as 50222-280-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 50222-0280-30, written without dashes as 50222028030. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 50222-0280-30, the first segment (50222) is the labeler code FDA assigned to LEO Pharma, Inc; the middle segment (0280) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.

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 tube (50222-0280-91), 1 tube (50222-0280-99). 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.

📄 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 ⚠️ 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 💬 Medication Guide

🎯 Indications and Usage 115 words ▾

1 INDICATIONS AND USAGE ANZUPGO is indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Limitations of Use Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended. ANZUPGO is a Janus kinase (JAK) inhibitor indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable.

( 1 ) Limitations of Use: Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended. ( 1 )

⏱️ Dosage and Administration 175 words ▾

2 DOSAGE AND ADMINISTRATION See the full prescribing information for recommended immunizations prior to treatment. ( 2.1 ) Do not use more than 30 grams per 2 weeks or 60 grams per month. Apply twice daily to skin of the affected areas only on the hands and wrists. ( 2.2 ) For topical use only. Not for oral, ophthalmic, or intravaginal use. ( 2.2 )

2.1Recommended Immunizations Prior to Treatment Initiation Complete any necessary immunizations, including herpes zoster vaccinations, according to current immunization guidelines prior to ANZUPGO treatment [see Warnings and Precautions (5.3) ] .

2.2Recommended Dosage and Administration Do not use more than 30 grams per 2 weeks or 60 grams per month. Prior to applying ANZUPGO, clean and dry affected areas. Apply a thin layer of ANZUPGO, twice daily, to the affected areas only on the hands and wrists.

ANZUPGO is for topical use only. Not for oral, ophthalmic, or intravaginal use. Avoid contact with eyes, mouth, or other mucous membranes.

If contact with mucous membranes occurs, rinse thoroughly with water.

💊 Dosage Forms and Strengths 38 words ▾

3 DOSAGE FORMS AND STRENGTHS Cream, 2%: Each gram of ANZUPGO cream contains 20 mg of delgocitinib in a white to slightly brown cream. Cream: Each gram of ANZUPGO cream contains 20 mg of delgocitinib. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Serious Infections : ANZUPGO may increase the risk of infection. Eczema herpeticum was observed in a subject treated topically with ANZUPGO. Avoid use of ANZUPGO in patients with an active or serious infection.

If a serious infection develops, discontinue ANZUPGO until the infection resolves. ( 5.1 ) Non-melanoma Skin Cancers: Non-melanoma skin cancers including basal cell carcinoma have been reported in subjects treated with ANZUPGO. Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer.

( 5.2 ) Immunizations: Avoid vaccination with live vaccines immediately prior to, during, and immediately after ANZUPGO treatment. ( 5.3 ) Potential Risks Related to JAK Inhibition: It is not known whether ANZUPGO may be associated with the observed or potential adverse reactions of JAK inhibition. Higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with a JAK inhibitor compared to those treated with TNF blockers in rheumatoid arthritis (RA) patients.

ANZUPGO is not approved for use in RA. Treatment with oral and topical JAK inhibitors has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides. Treatment with oral JAK inhibitors has been associated with hypoglycemia in patients with diabetes.

( 5.4 )

5.1Serious Infections ANZUPGO may increase the risk of infections. Eczema herpeticum was observed in a subject treated with ANZUPGO [see Adverse Reactions (6.1) ] . Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving oral or topical JAK inhibitors. [see Adverse Reactions (6.1) ] .

Avoid use of ANZUPGO in patients with an active or serious infection. Consider the risks and benefits of treatment prior to initiating ANZUPGO in patients: with chronic or recurrent infection who have been exposed to tuberculosis with a history of a serious or an opportunistic infection with underlying conditions that may predispose them to infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with ANZUPGO.

A patient who develops a new infection during treatment with ANZUPGO should undergo prompt and complete diagnostic testing; appropriate antimicrobial therapy should be initiated; and the patient should be closely monitored. Interrupt treatment with ANZUPGO if a patient develops a serious infection. Do not resume ANZUPGO until the infection resolves or is adequately treated.

Viral Reactivation Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical trials with ANZUPGO. If a patient develops herpes zoster, consider interrupting ANZUPGO treatment until the episode resolves. The impact of ANZUPGO on chronic viral hepatitis reactivation is unknown.

Patients with active hepatitis B or C infection were excluded from clinical trials with ANZUPGO. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting therapy and during therapy with ANZUPGO. If signs of reactivation occur, consult a hepatitis specialist.

ANZUPGO is not recommended for use in patients with active hepatitis B or hepatitis C.

5.2Non-melanoma Skin Cancers Non-melanoma skin cancers including basal cell carcinoma have been reported in subjects treated with ANZUPGO. Periodic skin examinations of the application sites are recommended for all patients, particularly those with risk factors for skin cancer. Advise patients to avoid sunlamps and minimize exposure to sunlight by wearing sun-protective clothing or using broad-spectrum sunscr…

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS Adverse reactions that were reported in ≤ 1% of subjects were application site pain, paresthesia, pruritus, erythema, and bacterial skin infections including finger cellulitis, paronychia, other skin infections, leukopenia, and neutropenia. ( 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 clinical practice. The safety of ANZUPGO was evaluated in two randomized, double-blind, multicenter, vehicle-controlled clinical trials (TRIAL 1 and TRIAL 2), in which 959 adults with moderate to severe CHE received ANZUPGO or vehicle cream topically twice daily for 16 weeks.

A total of 638 subjects were treated with ANZUPGO [see Clinical Studies (14) ] . In TRIAL 1 and TRIAL 2, adverse reactions that were reported in ≤ 1% of subjects in the ANZUPGO group were application site pain, paresthesia, pruritus, erythema, and bacterial skin infections including finger cellulitis, paronychia, other skin infections, leukopenia, and neutropenia. In an open label extension trial (TRIAL 3), 801 subjects were treated for up to an additional 36 weeks after completing TRIAL 1 or TRIAL 2.

A total of 198 subjects received continuous treatment with ANZUPGO for 52 weeks. Eczema herpeticum was observed in one subject and herpes zoster was observed in two subjects treated with ANZUPGO.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary The available data on the use of topical delgocitinib during pregnancy is insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of delgocitinib to pregnant rats and rabbits during the period of organogenesis did not result in adverse developmental effects at doses 120 or 193 times, respectively, the maximum recommended human dose (MRHD) based on AUC comparison (see Data ) .

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, and 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%-4% and 15%-20%, respectively.

Data Animal Data In embryofetal development studies, delgocitinib was administered orally to pregnant rats or rabbits during the period of organogenesis at doses of 3, 10, and 30 mg/kg/day in rats, and 1, 3 and 10 mg/kg/day in rabbits, respectively. In rats, no significant maternal toxicity was noted at doses up to 30 mg/kg/day (1446 times the MRHD based on AUC comparison). Decreases in fetal weight and skeletal variations were observed at doses ≥10 mg/kg/day (512 times the MRHD based on AUC comparison).

An increase in post-implantation loss was observed at 30 mg/kg/day (1446 times the MRHD based on AUC comparison). No embryofetal toxicity was noted at 3 mg/kg/day (120 times the MRHD based on AUC comparison). In rabbits, no significant maternal toxicity was noted at doses up to 10 mg/kg/day (992 times the MRHD based on AUC comparison).

An increase in post-implantation loss, reduced number of live fetuses, and decrease in fetal weights were observed at 10 mg/kg/day (992 times the MRHD based on AUC comparison). No embryofetal toxicity was noted at 3 mg/kg/day (193 times the MRHD based on AUC comparison). In a pre- and post-natal development study in pregnant rats, delgocitinib was orally administered at doses of 3, 10, and 30 mg/kg/day from gestation day 7 to lactation day 20.

No significant maternal toxicity was noted at 30 mg/kg/day (1555 times the MRHD based on AUC comparison). Extended gestation period, a decrease in the birth index, and an increase in the number of dead newborns were observed at 30 mg/kg/day (1555 times the MRHD based on AUC comparison). Decreased fetal viability and reduced pup weights were noted during the early postnatal period at 30 mg/kg/day (1555 times the MRHD based on AUC comparison).

No developmental toxicity was noted at 10 mg/kg/day (378 times the MRHD based on AUC comparison).

8.2Lactation Risk Summary There are no data on the presence of delgocitinib in human milk, the effects on the breastfed infant, or the effects on milk production. After oral administration, delgocitinib was present in the milk of lactating rats. 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 should be considered along with the mother's clinical need for ANZUPGO and any potential adverse effects on the breastfed infant from ANZUPGO or from the underlying maternal condition. Clinical Considerations To minimize potential infant exposure, advise breastfeeding women to avoid direct contact with the nipple and surrounding area immediately after applying ANZUPGO to the hands and/or wrists.

8.4Pediatric Use The safety and efficacy of ANZUPGO have not been established in pediatric patients.

8.5Geriatric Use Of the 691 subjects exposed to ANZUPGO in clinical trials, 59 subjects (8.5%) were 65 years of age and older and 10 subjects (1.4%) were 75 years of age and older. No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger adult subjects.

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary The available data on the use of topical delgocitinib during pregnancy is insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of delgocitinib to pregnant rats and rabbits during the period of organogenesis did not result in adverse developmental effects at doses 120 or 193 times, respectively, the maximum recommended human dose (MRHD) based on AUC comparison (see Data ) .

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, and 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%-4% and 15%-20%, respectively.

Data Animal Data In embryofetal development studies, delgocitinib was administered orally to pregnant rats or rabbits during the period of organogenesis at doses of 3, 10, and 30 mg/kg/day in rats, and 1, 3 and 10 mg/kg/day in rabbits, respectively. In rats, no significant maternal toxicity was noted at doses up to 30 mg/kg/day (1446 times the MRHD based on AUC comparison). Decreases in fetal weight and skeletal variations were observed at doses ≥10 mg/kg/day (512 times the MRHD based on AUC comparison).

An increase in post-implantation loss was observed at 30 mg/kg/day (1446 times the MRHD based on AUC comparison). No embryofetal toxicity was noted at 3 mg/kg/day (120 times the MRHD based on AUC comparison). In rabbits, no significant maternal toxicity was noted at doses up to 10 mg/kg/day (992 times the MRHD based on AUC comparison).

An increase in post-implantation loss, reduced number of live fetuses, and decrease in fetal weights were observed at 10 mg/kg/day (992 times the MRHD based on AUC comparison). No embryofetal toxicity was noted at 3 mg/kg/day (193 times the MRHD based on AUC comparison). In a pre- and post-natal development study in pregnant rats, delgocitinib was orally administered at doses of 3, 10, and 30 mg/kg/day from gestation day 7 to lactation day 20.

No significant maternal toxicity was noted at 30 mg/kg/day (1555 times the MRHD based on AUC comparison). Extended gestation period, a decrease in the birth index, and an increase in the number of dead newborns were observed at 30 mg/kg/day (1555 times the MRHD based on AUC comparison). Decreased fetal viability and reduced pup weights were noted during the early postnatal period at 30 mg/kg/day (1555 times the MRHD based on AUC comparison).

No developmental toxicity was noted at 10 mg/kg/day (378 times the MRHD based on AUC comparison).

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and efficacy of ANZUPGO have not been established in pediatric patients.

🧓 Geriatric Use 55 words ▾

8.5Geriatric Use Of the 691 subjects exposed to ANZUPGO in clinical trials, 59 subjects (8.5%) were 65 years of age and older and 10 subjects (1.4%) were 75 years of age and older. No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger adult subjects.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Delgocitinib, a Janus kinase (JAK) inhibitor, inhibits the activity of JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2). JAK signaling involves recruitment of signal transducers and activators of transcription (STATs) to cytokine receptors, and activation and subsequent localization of STATs to the nucleus, leading to the expression of cytokine-responsive genes to induce specific biological responses in target cells. The exact mechanism of action of delgocitinib in the treatment of moderate to severe CHE is currently not known.

12.2Pharmacodynamics Pharmacodynamics of delgocitinib in the treatment of CHE are unknown. Cardiac Electrophysiology At 193 times the mean maximal concentration provided by the recommended topical dose, clinically significant QTc interval prolongation was not observed.

12.3Pharmacokinetics The pharmacokinetics of ANZUPGO were evaluated in a pharmacokinetic (PK) trial involving 15 adult subjects 22 to 69 years of age with moderate to severe CHE and in 313 subjects in TRIAL 2 [see Clinical Studies (14) ] . Absorption In the PK trial, subjects applied on average 0.87 g of ANZUPGO topically to the affected areas of the hands and wrists twice a day for 8 days. The mean ± SD maximum plasma concentration (C max ) and area under the concentration-curve from time 0 to 12 hours (AUC 0-12 ) on Day 1 was 1.53 ng/mL ± 2.24 and 6.1 ng*h/mL ± 8.14, respectively.

The lower limit of quantification was 0.005 ng/mL in the assay. The systemic exposure (AUC and C max ) between Day 1 and Day 8 were similar. There was no evidence of accumulation with twice daily topical application of ANZUPGO.

In TRIAL 2, a single PK sample was assessed between 2-6 hours following twice daily application of ANZUPGO. The mean plasma concentration on Weeks 1, 4, and 16 were 0.42 ng/mL, 0.50 ng/mL, and 0.35 ng/mL, respectively. Distribution Plasma protein binding of delgocitinib is 22 to 29%.

Elimination Following repeated topical application of ANZUPGO, the average half-life of delgocitinib was estimated to be 21 hours. Metabolism Delgocitinib does not undergo extensive metabolism and the main plasma component is unchanged delgocitinib. Following oral administration, four metabolites (formed via oxidation and glucuronide conjugation) were detected at < 2% of the average unchanged delgocitinib plasma concentrations.

The limited metabolism of delgocitinib occurs primarily though CYP3A4/5 and to a lesser extent by CYP1A1, CYP2C9, CYP2C19, and CYP2D6. Excretion Delgocitinib is primarily eliminated by renal excretion as approximately 75% of the total dose after oral administration was found unchanged in the urine. Drug Interaction Studies Clinical Studies Drug interaction studies with ANZUPGO have not been conducted.

In Vitro Studies Delgocitinib does not inhibit or induce cytochrome P450 enzymes or inhibit transporter systems such as P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), organic anion transporting proteins (OATP), organic anion transporters (OAT), organic cation transporters (OCT), or multidrug and toxin extrusion protein (MATE) at clinically relevant concentrations.

🧬 Mechanism of Action 81 words ▾

12.1Mechanism of Action Delgocitinib, a Janus kinase (JAK) inhibitor, inhibits the activity of JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2). JAK signaling involves recruitment of signal transducers and activators of transcription (STATs) to cytokine receptors, and activation and subsequent localization of STATs to the nucleus, leading to the expression of cytokine-responsive genes to induce specific biological responses in target cells. The exact mechanism of action of delgocitinib in the treatment of moderate to severe CHE is currently not known.

📦 How Supplied / Storage and Handling 67 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ANZUPGO is a white to slightly brown cream containing 2% delgocitinib (each gram contains 20 mg of delgocitinib) and is supplied in the following package: 30 g laminated tubes: NDC 50222-280-30 Storage and Handling Store ANZUPGO at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze.

📦 Storage and Handling 29 words ▾

Storage and Handling Store ANZUPGO at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze.

📋 Description 124 words ▾

11 DESCRIPTION ANZUPGO (delgocitinib) cream is a white to slightly brown cream for topical use and contains delgocitinib as the active ingredient. Delgocitinib is a white to almost white powder. Delgocitinib is slightly soluble in aqueous solutions at pH 5.0.

The pKa of delgocitinib is 5.5. Delgocitinib is a Janus kinase (JAK) inhibitor [JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2)] with the chemical name 3-[(3S,4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-1-yl]-3-oxopropanenitrile. The molecular formula is C 16 H 18 N 6 O and the molecular weight is 310.35 g/mol.

Delgocitinib has the structural formula: Each gram of ANZUPGO contains 20 mg of delgocitinib. Inactive ingredients include benzyl alcohol, butylated hydroxyanisole, cetostearyl alcohol, citric acid monohydrate, edetate disodium, hydrochloric acid, mineral oil, polyoxyl 20 cetostearyl ether, and purified water. Image

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise patients to read the FDA-approved patient labeling (Patient Information). Administration Instructions Advise patients that ANZUPGO is for topical use only and is not for ophthalmic, oral, or intravaginal use [see Dosage and Administration (2.2) ]. Advise patients to limit treatment to 30 grams per 2 weeks or 60 grams per month. [see Dosage and Administration (2.2) ].

Instruct patients to clean and dry affected areas prior to applying ANZUPGO. Instruct patients to apply ANZUPGO, twice daily, to affected areas only on the hands and wrists, and avoid contact with eyes, mouth, or other mucous membranes [see Dosage and Administration (2.2) ]. Serious Infections Inform patients that ANZUPGO may lower the ability of their immune system to fight infections and to contact their healthcare provider immediately if they develop any signs or symptoms of infection [see Warnings and Precautions (5.1) ].

Non-melanoma Skin Cancers Inform patients that ANZUPGO may increase the risk of developing non-melanoma skin cancers. Inform patients that periodic skin examinations should be performed while using ANZUPGO. Instruct patients to inform their healthcare provider if they have ever had any type of cancer.

Advise patients to avoid sunlamps and minimize exposure to sunlight by wearing sun-protective clothing or using broad-spectrum sunscreen [see Warnings and Precautions (5.2) ] . Immunizations Advise patients treated with ANZUPGO to avoid use of live vaccines immediately prior to, during, and immediately after treatment [see Warnings and Precautions (5.3) ] . Lactation Advise breastfeeding women to avoid direct contact with the nipple and surrounding area immediately after applying ANZUPGO to the hands and/or wrists to minimize infant exposure [see Use in Specific Populations (8.2) ] .

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE ANZUPGO ® (an zup goe) (delgocitinib) cream This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 06/2026 Important: ANZUPGO is for use on the skin (topical use) only.

Do not use ANZUPGO in or on your eyes, mouth, or vagina. What is the most important information I should know about ANZUPGO? ANZUPGO may cause serious side effects, including: Serious Infections.

ANZUPGO may increase your risk of infections. ANZUPGO contains delgocitinib. Delgocitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors.

JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth or applying on the skin, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body.

Some people have been hospitalized or died from these infections. ANZUPGO should not be used in people with an active, serious infection. You should not start using ANZUPGO if you have any kind of infection unless your healthcare provider tells you it is okay.

You may be at a higher risk of developing shingles (herpes zoster) or eczema herpeticum (a blistery, painful skin rash) during treatment with ANZUPGO. Before starting ANZUPGO, tell your healthcare provider if you : are being treated for an infection have an infection that does not go away or that keeps coming back have TB or have been in close contact with someone with TB have had shingles (herpes zoster) have had hepatitis B or C think you have an infection or have symptoms of an infection such as: fever, sweating, or chills muscle aches cough or shortness of breath blood in your phlegm weight loss warm, red, or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinating more often than usual feeling very tired After starting ANZUPGO, call your healthcare provider right away if you have any symptoms of an infection.

ANZUPGO can make you more likely to get infections or make worse any infections that you have. If you get a serious infection, your healthcare provider may stop your treatment with ANZUPGO until your infection is controlled. Non-melanoma skin cancer.

ANZUPGO may increase your risk of certain non-melanoma skin cancers.Your healthcare provider will regularly check your skin during your treatment with ANZUPGO. Avoid sunlamps and limit the amount of time you spend in the sunlight. Wear protective clothing when you are in the sun or use a broad-spectrum sunscreen.

Tell your healthcare provider if you have ever had any type of cancer. Potential risks from Janus kinase (JAK) inhibition. It is not known whether using ANZUPGO has the same risks as taking other oral or topical JAK inhibitors.

Increased risk of death (all causes) has happened in people who were 50 years of age and older with at least 1 heart disease (cardiovascular) risk factor who were taking a JAK inhibitor used to treat rheumatoid arthritis (RA) compared to people taking another medicine in a class of medicines called TNF blockers. ANZUPGO is not for use in people with RA. Other oral or topical JAK inhibitors have also caused increased cholesterol.

Low blood sugar in people with diabetes has happened after taking JAK inhibitors by mouth. See " What are the possible side effects of ANZUPGO? " for more information about side effects. What is ANZUPGO?

ANZUPGO is a prescription medicine used on the skin (topical) to treat moderate to severe chronic hand eczema in adults who are not well-controlled with, or cannot use topical corticosteroids. The use of ANZUPGO along with other JAK inhibitors or strong immunosuppressants is not recommended. It is not known if ANZUPGO is safe and effective in children.

Before using ANZUPGO, tell your healthcare provider about all your medical conditions, including if you: See " What is the most important informati…

Glossary — plain-language definitions of medical terms used in this label:

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

Active ingredient: The part of a medicine that produces its intended effect on the body.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

BCRP: A protein pump that moves certain drugs out of cells, affecting how much of the drug is absorbed.

broad-spectrum: Describes an antibiotic that works against a wide range of different bacteria.

cellulitis: A spreading bacterial infection of the skin and the tissue just beneath it.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

CYP2C19: A liver enzyme that breaks down certain medicines, such as some stomach-acid drugs and drugs that help prevent blood clots.

CYP2C9: A liver enzyme that breaks down certain medicines, including some blood thinners and anti-inflammatory drugs.

CYP2D6: A liver enzyme that breaks down many medicines; people inherit different versions, so it works faster in some and slower in others.

CYP3A4: One of the most important liver and gut enzymes, responsible for breaking down a large share of all medicines.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

embolism: A blockage of a blood vessel by a clot or other material that has traveled from elsewhere in the body.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

herpes zoster: The medical name for shingles, a painful rash caused by reactivation of the virus that causes chickenpox.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypoglycemia: Low blood sugar, when the amount of glucose (sugar) in the blood drops below the normal range.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

lactation: The making and release of milk from a mother's breasts after giving birth.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neutropenia: A low level of neutrophils, a type of white blood cell that fights infection, which can make it easier to catch infections.

OATP: A group of transporter proteins that carry certain drugs into cells, especially in the liver.

opportunistic infection: An infection caused by germs that usually don't make healthy people sick, but can take hold when the body's defenses are weak.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

P-glycoprotein: A tiny pump in cells that pushes certain medicines back out, affecting how much of a medicine is absorbed or stays in the body.

P-gp: A protein pump in cells that pushes certain drugs back out, limiting how much is absorbed or reaches tissues.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

pruritus: Itching of the skin.

pulmonary embolism: A blood clot that has traveled to the lungs and blocks blood flow there, which can make breathing hard.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

reactivation: When a germ that has been quiet in the body for a long time becomes active again and causes an infection.

renal excretion: Removal of a medicine from the body through the kidneys into the urine.

TB: A serious infection, usually of the lungs, caused by tuberculosis bacteria and spread through the air.

thrombosis: The forming of a blood clot inside a blood vessel, which can block normal blood flow.

topical: Applied onto the skin, eyes, or another body surface to work mainly where it is placed.

transporter: A protein that moves drugs across cell membranes, carrying them either into or out of cells.

tuberculosis: A serious infection, usually of the lungs, caused by tuberculosis bacteria and spread through the air.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

🔗 Related NDC lookups

🧪 All Delgocitinib NDCsSame ingredient 🏭 All LEO labeler NDCsLabeler code 50222 📚 All Janus Kinase Inhibitor NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Topical Janus Kinase (Jak) Inhibitors.

Ruxolitinib Phosphate 50881-0007-04

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.