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Danziten nilotinib 71 mg Tablet — NDC 24338-0154-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Danziten nilotinib 71 mg Tablet — NDC 24338-154-01 (Billing 24338-0154-01)

by Azurity Pharmaceuticals, Inc. · 4 CARTON in 1 CARTON / 2 BLISTER PACK in 1 CARTON / 14 TABLET in 1 BLISTER PACK

This is a package of Danziten nilotinib 71 mg Tablet from Azurity Pharmaceuticals, Inc., marketed since Nov 2024 and currently FDA-listed. It is this product's only package size.

NDC 24338-0154-01
🏷️ FDA NDC (as labeled) 24338-154-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 24338-154-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
24338 labeler · 154 product · 01 package
Package marketed since
Nov 30, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 2433815401 4
Medicaid fills, this package
15 prescriptions in the last four reported quarters
FDA record last changed
Oct 1, 2026
⚠️
Other active recalls for Nilotinib (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Feb 18, 2026 — Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test. (Cipla USA, Inc.) · FDA recall D-0381-2026
Class III · Feb 18, 2026 — Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test. (Cipla USA, Inc.) · FDA recall D-0382-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 24338-154-01
Product NDC 24338-154
11-digit billing NDC 24338015401
NCPDP billing unit EA — each (per item)
RxCUI 2698564, 2698570, 2698572, 2698574
UNII F41401512X
Application # NDA219293
SPL Set ID d288d165-3505-49bb-9b2e-124490d65f49
Established class (EPC) Kinase Inhibitor
Mechanism of action Bcr-Abl Tyrosine Kinase Inhibitors; Cytochrome P450 2C8 Inhibitors; Cytochrome P450 2D6 Inhibitors; Cytochrome P450 2B6 Inducers; Cytochrome P450 2C8 Inducers; UGT1A1 Inhibitors; P-Glycoprotein Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-11-30
Route ORAL
Dosage form TABLET
Substance NILOTINIB

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

GPI-14 21531860600320
GCN Seq No 086713
GCN 56461
HICL code 049984
Ingredient (HICL) Nilotinib Tartrate
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1Q
Therapeutic class — specific (HIC3) Antineoplastic Systemic Enzyme Inhibitors
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name DANZITEN 71 MG TABLET
FDB brand name Danziten
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 086713
  • GCN: 56461
  • GPI-14 (Medi-Span): 21531860600320
  • HICL (First Databank): 049984
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 2698564
Why two NDCs? The FDA registers this code as 24338-154-01 — 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 → 24338-0154-01. 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 Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor
Drug family (ATC) BCR-ABL tyrosine kinase inhibitors
How it works Bcr-Abl Tyrosine Kinase Inhibitors, Cytochrome P450 2D6 Inhibitors, P-Glycoprotein Inhibitors, Cytochrome P450 2C8 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.

Clinical

Label name DANZITEN 71 MG TABLET Ingredient Nilotinib Tartrate
📗 Our plain-language guide HelloPharmacist
  • It treats Ph+ CML, a type of chronic myeloid leukemia. It is used in newly diagnosed patients and in those whose earlier treatment, such as imatinib, stopped working or caused prob...
  • Take it by mouth twice a day, about 12 hours apart. Tasigna and nilotinib capsules must be taken with no food 2 hours before and 1 hour after. Danziten and Cavhanza can be taken wi...
  • Not on your own. Danziten and Cavhanza do not convert milligram for milligram with other nilotinib products, and a mix-up could mean too much or too little drug. Always check with...
  • Rash, itching, headache, nausea, tiredness, and constipation or diarrhea are common. Regular blood tests will track your blood counts and liver and other labs. Call right away for...
📖 Read our full Nilotinib 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.

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $161.03 $18,035.68 / 112 tablets
Medicare drug plans payPart D · Q2 2026 $163.21 $18,279.71 / 112 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
24338-0154-01 You're viewing this Main listing 4 CARTON in 1 CARTON / 2 BLISTER PACK in 1 CARTON / 14 TABLET in 1 BLISTER PACK 2024-11-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Danziten 71 mgthis 24338-0154-01 Azurity 1792 tablets — — 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

🏛️
2024
First FDA approval
Nov 2024
📍
2026
Currently FDA-listed
2 years listed
🛡️
2040
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 Feb 2040. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Nov 7, 2024 RLD RS ⏳ ~13.4 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 11793809 — drug product
US 10874671 — drug product
US 12629369 — drug product
US 12403140 — drug product
US 11793809 — drug product
US 10874671 — drug product
US 12403140 — drug product
US 12629369 — drug product
2024 2026 2028 2030 2032 2034 2036 2038 2040
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 (8)
PatentTypeUse codeExpires
US 11793809 ↗ Drug product — Feb 18, 2040
US 10874671 ↗ Drug product — Feb 18, 2040
US 12629369 ↗ Drug product — Feb 18, 2040
US 12403140 ↗ Drug product — Feb 18, 2040
US 11793809 ↗ Drug product — Feb 18, 2040
US 10874671 ↗ Drug product — Feb 18, 2040
US 12403140 ↗ Drug product — Feb 18, 2040
US 12629369 ↗ Drug product — Feb 18, 2040
Common questions
Is there a generic version of DANZITEN 71 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for DANZITEN 71 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Feb 2040 — 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAzurity Pharmaceuticals, Inc.
Application holderAZURITY PHARMACEUTICALS INC
FDA applicationNDA219293 (NDA)
Labeler code24338
First marketedNov 2024
Product typeHuman Prescription Drug
Portfolio57 products on file

More NDCs from Azurity Pharmaceuticals, Inc. labeler code 24338

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: QT PROLONGATION and SUDDEN DEATHS • Nilotinib prolongs the QT interval. Prior to DANZITEN administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies [ see Warnings and Precautions ( 5.3 ) ]. Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments [ see Warnings and Precautions ( 5.3 , 5.4 , 5.8 , 5.12 ) ]. • Sudden deaths have been reported in patients receiving nilotinib [ see Warnings and Precautions ( 5.4 ) ].

Do not administer DANZITEN tablets to patients with hypokalemia, hypomagnesemia, or long QT syndrome [ see Contraindications (4), Warnings and Precautions ( 5.3 ) ]. • Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors [ see Drug Interactions ( 7.1 , 7.2 ) ]. WARNING: QT PROLONGATION and SUDDEN DEATHS See full prescribing information for complete boxed warning. • Nilotinib prolongs the QT interval. Prior to DANZITEN administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies.

( 5.3 ) Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments. ( 5.3 , 5.4 , 5.8 , 5.12 ) • Sudden deaths have been reported in patients receiving nilotinib. ( 5.4 ) Do not administer DANZITEN to patients with hypokalemia, hypomagnesemia, or long QT syndrome.

( 4 , 5.3 ) • Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors. ( 7.1 , 7.2 )

🎯 Indications and Usage 200 words ▾

1 INDICATIONS AND USAGE DANZITEN is a kinase inhibitor indicated for the treatment of: • Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1 ) • Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. ( 1.2 )

1.1Adult Patients with Newly Diagnosed Ph+ CML-CP DANZITEN is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s Tasigna ® (nilotinib) capsules. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

1.2Adult Patients with Resistant or Intolerant Ph+ CML-CP and CML-AP DANZITEN is indicated for the treatment of adult patients with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) resistant or intolerant to prior therapy that included imatinib. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s Tasigna ® (nilotinib) capsules. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • To avoid medication errors and overdosage or under dosage, note that DANZITEN may have different strengths and dosages than other nilotinib products and may not be substitutable with other nilotinib products on a milligram per milligram basis. ( 2.1 ) • Recommended Adult Dose: • Newly diagnosed Ph+ CML-CP: 142 mg orally twice daily. • Resistant or intolerant Ph+ CML-CP and CML-AP: 190 mg orally twice daily. ( 2.2 ) • See Dosage and Administration for full dosing instructions and dose- reduction instructions for toxicity.

( 2.4 , 2.5 , 2.6 , 2.7 , 2.8 , 2.9 ) • Reduce starting dose in patients with baseline hepatic impairment. ( 2.8 ) • Eligible newly diagnosed adult patients with Ph+ CML-CP who have received DANZITEN for a minimum of 3 years and have achieved a sustained molecular response (MR4.5) and patients with Ph+ CML-CP resistant or intolerant to imatinib who have received DANZITEN for at least 3 years and have achieved a sustained molecular response (MR4.5) may be considered for treatment discontinuation. ( 2.3 , 2.4 , 5.16 )

2.1Important Use and Administration Instructions • Nilotinib is available in different formulations, dosage forms, and strengths that are approved with different indications and recommended dosages. • DANZITEN may not be substitutable with other nilotinib products on a milligram per milligram basis; to avoid medication errors, including overdosage or underdosage, when using DANZITEN ensure that the recommended dosage of DANZITEN (not the recommended dosage of other nilotinib products) is prescribed [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 )] . • When switching between DANZITEN (nilotinib) tablets and Tasigna (nilotinib) capsules, use the dosage conversion table [see Dosage and Administration ( 2.2 )] .

2.2Recommended Dosage and Administration Dosage in Adult Patients with Newly Diagnosed Ph+ CML-CP The recommended dosage of DANZITEN is 142 mg orally twice daily at approximately 12-hour intervals with or without food [see Clinical Pharmacology ( 12.3 )] . Dosage in Adult Patients with Resistant or Intolerant Ph+ CML-CP and CML-AP The recommended dosage of DANZITEN is 190 mg orally twice daily at approximately 12-hour intervals with or without food [see Clinical Pharmacology ( 12.3 )] . Additional Administration Instructions Advise patients to swallow the tablets whole with water and not to cut, crush, or chew the tablets [see Boxed Warning ].

If a dose of DANZITEN is missed, the patient should take the next scheduled dose at its regular time. The patient should not take two doses at the same time. Switching Instructions Use Table 1 when switching between DANZITEN and Tasigna based on dosage equivalence.

Table 1 Recommendations for Switching between DANZITEN and Tasigna Approved Indications DANZITEN dosage Tasigna dosage Newly diagnosed Ph+ CML-CP 142 mg orally twice daily 300 mg orally twice daily Resistant or intolerant Ph+ CML-CP and CML-AP 190 mg orally twice daily 400 mg orally twice daily Optional Concomitant Therapy DANZITEN may be given in combination with hematopoietic growth factors, such as erythropoietin or G-CSF if clinically indicated. DANZITEN may be given with hydroxyurea or anagrelide if clinically indicated.

Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s Tasigna (nilotinib) capsules. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

2.3Discontinuation of Treatment After a Sustained Molecular Response (MR4.5) on DANZITEN Patient Selection Eligibility for Discontinuation of Treatment Ph+ CML-CP patients with typical BCR-ABL transcripts, who have been taking DANZITEN for a minimum of 3 years and have achieved a sustained molecular response (MR4.5, corresponding to = BCR-ABL/ABL ≤ 0.0032% IS), may be eligible for treatment discontinuation [ see Clinical Studies ( 14.3 , 14.4 ) ]… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 65 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: • 71 mg: pink coated oblong tablets, debossed with “N5” on one side and plain on other side. Each tablet contains 71 mg of nilotinib. • 95 mg: yellow coated oblong tablets, debossed with “N2” on one side and plain on other side. Each tablet contains 95 mg of nilotinib. Tablets: 71 mg, and 95 mg ( 3 )

⛔ Contraindications 39 words ▾

4 CONTRAINDICATIONS DANZITEN is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome [see Boxed Warning and Warnings and Precautions ( 5.3 )]. DANZITEN is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Substitution with Other Nilotinib Products and Risk of Medication Errors : DANZITEN (nilotinib) tablets may not be substitutable with other nilotinib products, including other nilotinib tablets, on a milligram per milligram basis. Confirm that the intended nilotinib product is being prescribed and dispensed. ( 5.1 ) • Myelosuppression : Monitor complete blood count (CBC) during therapy and manage by treatment interruption or dose reduction.

( 5.2 ) • Cardiac and Arterial Vascular Occlusive Events : Evaluate cardiovascular status, monitor and manage cardiovascular risk factors during DANZITEN therapy. ( 5.5 ) • Pancreatitis and Elevated Serum Lipase : Monitor serum lipase; if elevations are accompanied by abdominal symptoms, interrupt doses and consider appropriate diagnostics to exclude pancreatitis. ( 5.6 ) • Hepatotoxicity : Monitor hepatic function tests monthly or as clinically indicated.

( 5.7 ) • Electrolyte Abnormalities : DANZITEN can cause hypophosphatemia, hypokalemia, hyperkalemia, hypocalcemia, and hyponatremia. Correct electrolyte abnormalities prior to initiating DANZITEN and monitor periodically during therapy. ( 5.8 ) • Tumor Lysis Syndrome : Maintain adequate hydration and correct uric acid levels prior to initiating therapy with DANZITEN.

( 5.9 ) • Hemorrhage : Hemorrhage from any site may occur. Advise patients to report signs and symptoms of bleeding and medically manage as needed. ( 5.10 ) • Fluid Retention : Monitor patients for unexpected rapid weight gain, swelling, and shortness of breath.

Manage medically. ( 5.13 ) • Effects on Growth and Development in Pediatric Patients : Growth retardation has been reported in pediatric patients treated with nilotinib. Monitor growth and development in pediatric patients.

( 5.14 ) • Embryo-Fetal Toxicity : Can cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception. ( 5.15 , 8.1 , 8.3 ) • Treatment Discontinuation : Patients must have typical BCR-ABL transcripts.

An FDA-authorized test with a detection limit below MR4.5 must be used to determine eligibility for discontinuation. Patients must be frequently monitored by the FDA authorized test to detect possible loss of remission. ( 5.16 )

5.1Substitution with Other Nilotinib Products and Risk of Medication Errors Nilotinib is available in different formulations, recommended dosages, and tablet strengths, and for different indications. DANZITEN (nilotinib) tablets may not be substitutable with other nilotinib products, including other nilotinib tablets, on a milligram per milligram basis. When switching patients between other nilotinib products and DANZITEN (nilotinib) tablets, a dose conversion may be required [see Dosage and Administration ( 2.1 and 2.2 )] .

Substitution of DANZITEN (nilotinib) tablets for another nilotinib product to achieve the same daily nilotinib dosage on a milligram per milligram basis may result in a clinically significant: • Increase in nilotinib exposure which may increase the risk of nilotinib-associated adverse reactions. • Decrease in nilotinib exposure which may reduce DANZITEN effectiveness. Confirm that the intended nilotinib product is being prescribed and dispensed.

5.2Myelosuppression Treatment with DANZITEN can cause Grade 3/4 thrombocytopenia, neutropenia, and anemia. Perform CBCs every 2 weeks for the first 2 months and then monthly thereafter, or as clinically indicated. Myelosuppression was generally reversible and usually managed by withholding DANZITEN temporarily or dose reduction [ see Dosage and Administration ( 2.6 ) ].

5.3QT Prolongation Nilotinib has been shown to prolong cardiac ventricular repolarization as measured by the QT interval on the surface electrocardiogram (ECG) in a concentration-dependent manner [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.2 )] . Prolongation of the QT interval can result in a type of ventricular tachycardia called torsade de… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions can occur with DANZITEN and are discussed in greater detail in other sections of labeling: • Myelosuppression [ see Warnings and Precautions ( 5.2 ) ] • QT Prolongation [ see Boxed Warning, Warnings and Precautions ( 5.3 ) ] • Sudden Deaths [ see Boxed Warning, Warnings and Precautions ( 5.4 ) ] • Cardiac and Arterial Vascular Occlusive Events [ see Warnings and Precautions ( 5.5 ) ] • Pancreatitis and Elevated Serum Lipase [ see Warnings and Precautions ( 5.6 ) ] • Hepatotoxicity [ see Warnings and Precautions ( 5.7 ) ] • Electrolyte Abnormalities [ see Boxed Warning, Warnings and Precautions ( 5.8 ) ] • Hemorrhage [ see Warnings and Precautions ( 5.10 ) ] • Fluid Retention [ see Warnings and Precautions ( 5.13 ) ] The most commonly reported non-hematologic adverse reactions (≥ 20%) in adult patients are nausea, rash, headache, fatigue, pruritus, vomiting, diarrhea, cough, constipation, arthralgia, nasopharyngitis, pyrexia, and night sweats.

Hematologic adverse drug reactions include myelosuppression: thrombocytopenia, neutropenia, and anemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc., at 1-800-461-7449 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. The safety of DANZITEN (nilotinib) tablets has been established from adequate and well-controlled studies of Tasigna ® (nilotinib) capsules, which has different recommended dosages than DANZITEN, in adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) and adult patients with CP and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib [see Clinical Studies ( 14 )] .

Below is a display of the adverse reactions of Tasigna ® (nilotinib) capsules in these adequate and well-controlled studies. In Adult Patients With Newly Diagnosed Ph+ CML-CP The data below reflect exposure to nilotinib from a randomized trial in patients with newly diagnosed Ph+ CML in chronic phase treated at the equivalent recommended dosage of DANZITEN 142 mg twice daily (n = 279). The median time on treatment at the equivalent recommended dosage of DANZITEN 142 mg twice daily group was 61 months (range, 0.1 to 71 months).

The most common (greater than 10%) non-hematologic adverse drug reactions were rash, pruritus, headache, nausea, fatigue, alopecia, myalgia, and upper abdominal pain. Constipation, diarrhea, dry skin, muscle spasms, arthralgia, abdominal pain, peripheral edema, vomiting, and asthenia were observed less commonly (less than or equal to 10% and greater than 5%). Increase in QTcF greater than 60 msec from baseline was observed in 1 patient (0.4%) at the equivalent recommended dosage of DANZITEN 142 mg twice daily treatment group.

No patient had an absolute QTcF of greater than 500 msec while on study drug. The most common hematologic adverse drug reactions (all Grades) were myelosuppression, including: thrombocytopenia (18%), neutropenia (15%), and anemia (8%). See Table 10 for Grade 3/4 laboratory abnormalities.

Discontinuation due to adverse reactions, regardless of relationship to study drug, was observed in 10% of patients. In Adult Patients With Resistant or Intolerant Ph+ CML-CP and CML-AP In the single-arm, open-label multicenter clinical trial, a total of 458 patients with Ph+ CML-CP and CML-AP resistant to or intolerant to at least one prior therapy, including imatinib were treated (CML-CP = 321; CML-AP = 137) at the equivalent recommended dosage of DANZITEN 190 mg twice daily. The median duration of exposure in days for CML-CP and CML-AP patients is 561 (range, 1 to 1… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS • Strong CYP3A Inhibitors : Avoid concomitant use with DANZITEN or reduce DANZITEN dose if concomitant use cannot be avoided. ( 7.1 ) • Strong CYP3A Inducers : Avoid concomitant use with DANZITEN. ( 7.1 ) • Proton Pump Inhibitors : Use short-acting antacids or H2 blockers as an alternative to proton pump inhibitors. ( 7.1 )

7.1Effect of Other Drugs on DANZITEN Strong CYP3A Inhibitors Avoid concomitant use of strong CYP3A inhibitors with DANZITEN. If concomitant use cannot be avoided, reduce DANZITEN dose [see Dosage and Administration ( 2.9 )] . Nilotinib is a CYP3A substrate [see Clinical Pharmacology ( 12.3 )].

Concomitant use with a strong CYP3A inhibitor increases nilotinib exposure [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of DANZITEN adverse reactions. Strong CYP3A Inducers Avoid concomitant use of strong CYP3A inducers with DANZITEN. Nilotinib is a CYP3A substrate [see Clinical Pharmacology ( 12.3 )] .

Concomitant use with a strong CYP3A inducer decreases nilotinib exposure [see Clinical Pharmacology ( 12.3 )] , which may reduce DANZITEN efficacy. Proton Pump Inhibitors Avoid concomitant use of PPI with DANZITEN. As an alternative to PPIs, use H 2 blockers approximately 10 hours before or approximately 2 hours after the dose of DANZITEN, or use antacids approximately 2 hours before or approximately 2 hours after the dose of DANZITEN.

Nilotinib displays pH-dependent aqueous solubility [see Description ( 11 )] . Concomitant use with a proton pump inhibitor (PPI) decreases nilotinib concentrations [see Clinical Pharmacology ( 12.3 )] , which may reduce DANZITEN efficacy.

7.2Drugs that Prolong the QT Interval Avoid coadministration of DANZITEN with agents that may prolong the QT interval, such as anti-arrhythmic drugs [see Boxed Warning, Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.3 ), Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.2 )]. Nilotinib is associated with a clinically significant concentration-dependent QT prolongation [see Clinical Pharmacology ( 12.2 )].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Lactation: Advise women not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on findings from animal studies and the mechanism of action, DANZITEN can cause fetal harm when administered to a pregnant woman [ see Clinical Pharmacology ( 12.1 ) ]. There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of nilotinib to pregnant rats and rabbits during organogenesis caused adverse developmental outcomes, including embryo-fetal lethality, fetal effects, and fetal variations in rats and rabbits at maternal exposures (AUC) approximately 2 and 0.5 times, respectively, the exposures in patients at the recommended dose (see Data).

Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2%-4% and 15%-20%, respectively. Data Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of nilotinib up to 100 mg/kg/day and 300 mg/kg/day, respectively, during the period of organogenesis. In rats, oral administration of nilotinib produced embryo-lethality/fetal effects at doses ≥ 30 mg/kg/day.

At ≥ 30 mg/kg/day, skeletal variations of incomplete ossification of the frontals and misshapen sternebra were noted, and there was an increased incidence of small renal papilla and fetal edema. At 100 mg/kg/day, nilotinib was associated with maternal toxicity (decreased gestation weight, gravid uterine weight, net weight gain, and food consumption) and resulted in a single incidence of cleft palate and two incidences of pale skin were noted in the fetuses. A single incidence of dilated ureters was noted in a fetus also displaying small renal papilla at 100 mg/kg/day.

Additional variations of forepaw and hindpaw phalanx unossified, fused sternebra, bipartite sternebra ossification, and incomplete ossification of the cervical vertebra were noted at 100 mg/kg/day. In rabbits, oral administration of nilotinib resulted in the early sacrifice of two females, maternal toxicity and increased resorption of fetuses at 300 mg/kg/day. Fetal skeletal variations (incomplete ossification of the hyoid, bent hyoid, supernumerary short detached ribs and the presence of additional ossification sites near the nasals, frontals and in the sternebral column) were also increased at this dose in the presence of maternal toxicity.

Slight maternal toxicity was evident at 100 mg/kg/day but there were no reproductive or embryo-fetal effects at this dose. At 30 mg/kg/day in rats and 300 mg/kg/day in rabbits, the maternal systemic exposure (AUC) were 72700 ng*hr/mL and 17100 ng*hr/mL respectively, representing approximately 2 and 0.5 times the exposure in humans at the highest recommended dose 400 mg twice daily. When pregnant rats were dosed with nilotinib during organogenesis and through lactation, the adverse effects included a longer gestational period, lower pup body weights until weaning and decreased fertility indices in the pups when they reached maturity, all at a maternal dose of 60 mg/kg (i.e., 360 mg/m2, approximately 0.7 times the clinical dose of 400 mg twice daily based on body surface area).

At doses up to 20 mg/kg (i.e., 120 mg/m2, approximately 0.25 times the clinical dose of 400 mg twice daily based on body surface area) no adverse effects were seen in the maternal animals or the pups.

8.2Lactation Risk Summary There are no data on the presence of nilotinib or its metabolites in human milk or its effects on a breastfed child or on milk production. However, nilotinib is present in the milk of lactating rats. Because of the potential for serious adverse reactions in a breastfed child, a… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on findings from animal studies and the mechanism of action, DANZITEN can cause fetal harm when administered to a pregnant woman [ see Clinical Pharmacology ( 12.1 ) ]. There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of nilotinib to pregnant rats and rabbits during organogenesis caused adverse developmental outcomes, including embryo-fetal lethality, fetal effects, and fetal variations in rats and rabbits at maternal exposures (AUC) approximately 2 and 0.5 times, respectively, the exposures in patients at the recommended dose (see Data).

Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2%-4% and 15%-20%, respectively. Data Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of nilotinib up to 100 mg/kg/day and 300 mg/kg/day, respectively, during the period of organogenesis. In rats, oral administration of nilotinib produced embryo-lethality/fetal effects at doses ≥ 30 mg/kg/day.

At ≥ 30 mg/kg/day, skeletal variations of incomplete ossification of the frontals and misshapen sternebra were noted, and there was an increased incidence of small renal papilla and fetal edema. At 100 mg/kg/day, nilotinib was associated with maternal toxicity (decreased gestation weight, gravid uterine weight, net weight gain, and food consumption) and resulted in a single incidence of cleft palate and two incidences of pale skin were noted in the fetuses. A single incidence of dilated ureters was noted in a fetus also displaying small renal papilla at 100 mg/kg/day.

Additional variations of forepaw and hindpaw phalanx unossified, fused sternebra, bipartite sternebra ossification, and incomplete ossification of the cervical vertebra were noted at 100 mg/kg/day. In rabbits, oral administration of nilotinib resulted in the early sacrifice of two females, maternal toxicity and increased resorption of fetuses at 300 mg/kg/day. Fetal skeletal variations (incomplete ossification of the hyoid, bent hyoid, supernumerary short detached ribs and the presence of additional ossification sites near the nasals, frontals and in the sternebral column) were also increased at this dose in the presence of maternal toxicity.

Slight maternal toxicity was evident at 100 mg/kg/day but there were no reproductive or embryo-fetal effects at this dose. At 30 mg/kg/day in rats and 300 mg/kg/day in rabbits, the maternal systemic exposure (AUC) were 72700 ng*hr/mL and 17100 ng*hr/mL respectively, representing approximately 2 and 0.5 times the exposure in humans at the highest recommended dose 400 mg twice daily. When pregnant rats were dosed with nilotinib during organogenesis and through lactation, the adverse effects included a longer gestational period, lower pup body weights until weaning and decreased fertility indices in the pups when they reached maturity, all at a maternal dose of 60 mg/kg (i.e., 360 mg/m2, approximately 0.7 times the clinical dose of 400 mg twice daily based on body surface area).

At doses up to 20 mg/kg (i.e., 120 mg/m2, approximately 0.25 times the clinical dose of 400 mg twice daily based on body surface area) no adverse effects were seen in the maternal animals or the pups.

🧒 Pediatric Use 161 words ▾

8.4Pediatric Use The frequency, type, and severity of adverse reactions observed were generally consistent with those observed in adults, with the exception of the laboratory abnormalities of hyperbilirubinemia (Grade 3/4: 16%) and transaminase elevation (AST Grade 3/4: 2.9%, ALT Grade 3/4: 10%), which were reported at a higher frequency in pediatric patients than in adults [see Adverse Reactions (6.1)] . For pediatric growth and development, growth retardation has been reported in pediatric patients with Ph+ CML-CP treated with nilotinib [see Warnings and Precautions ( 5.14 and 5.12 ), Adverse Reactions ( 6.1 )].

The safety and effectiveness of nilotinib in pediatric patients below the age of 1 year with newly diagnosed, or resistant or intolerant Ph+ CML in chronic phase and accelerated phase, have not been established. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s Tasigna ® (nilotinib) capsules. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

🧓 Geriatric Use 156 words ▾

8.5Geriatric Use In the clinical trials of nilotinib (patients with newly diagnosed Ph+ CML-CP and resistant or intolerant Ph+ CML-CP and CML-AP), approximately 12% and 30% of patients were 65 years or over respectively. • Patients with newly diagnosed Ph+ CML-CP: There was no difference in major molecular response between patients aged less than 65 years and those greater than or equal to 65 years. • Patients with resistant or intolerant CML-CP: There was no difference in major cytogenetic response rate between patients aged less than 65 years and those greater than or equal to 65 years. • Patients with resistant or intolerant CML-AP: The hematologic response rate was 44% in patients less than 65 years of age and 29% in patients greater than or equal to 65 years.

No major differences for safety were observed in patients greater than or equal to 65 years of age as compared to patients less than 65 years.

🆘 Overdosage 42 words ▾

10 OVERDOSAGE Overdose with nilotinib has been reported, where an unspecified number of nilotinib were ingested in combination with alcohol and other drugs. Events included neutropenia, vomiting, and drowsiness. In the event of overdose, observe the patient and provide appropriate supportive treatment.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Nilotinib is an inhibitor of the BCR-ABL kinase. Nilotinib binds to and stabilizes the inactive conformation of the kinase domain of ABL protein. In vitro, nilotinib inhibited BCR-ABL mediated proliferation of murine leukemic cell lines and human cell lines derived from patients with Ph+ CML.

Under the conditions of the assays, nilotinib was able to overcome imatinib resistance resulting from BCR-ABL kinase mutations, in 32 out of 33 mutations tested. Nilotinib inhibited the autophosphorylation of the following kinases at IC50 values as indicated: BCR-ABL (20 to 60 nM), PDGFR (69 nM), c-KIT (210 nM), CSF-1R (125 to 250 nM), and DDR1 (3.7 nM).

12.2Pharmacodynamics A relationship between nilotinib exposure and a greater likelihood of response and safety events, including a higher occurrence of total bilirubin elevations, was observed in clinical studies. Nilotinib time course of pharmacodynamic response is unknown. Cardiac Electrophysiology Nilotinib is associated with concentration-dependent QT prolongation.

At the equivalent recommended dosage of DANZITEN 190 mg twice daily given without food in healthy subjects, the maximum mean placebo-adjusted QTcF changes were 10.4 msec (90% CI: 2.85, 18.0). After a single equivalent recommended dose of DANZITEN 380 mg (two times the maximum approved recommended dose) given with a high fat meal to healthy subjects, the maximum mean placebo-adjusted QTcF changes were) 18.0 msec (90% CI: 9.65, 25.8). Peak plasma concentrations in the QT study were 26% lower than or comparable with those observed in patients enrolled in the single-arm study [see Boxed Warning, Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 )] .

No new significant QT findings were observed in healthy subject studies with single doses of DANZITEN given with or without food. Throughout the 14 PK studies there were no QT prolongation events associated with DANZITEN.

12.3Pharmacokinetics Nilotinib single-dose maximum concentration (Cmax), area under the time concentration curve (AUC), predicted steady-state maximum concentration (Cmax,ss) and area under the time concentration curve (AUCss) in fasted subjects receiving the DANZITEN approved recommended dosages are presented in Tables 11 and 12. Table 11: Nilotinib mean ±SD single-dose exposure in fasted patients receiving the DANZITEN approved recommended dosages DANZITEN Dosage C max AUC 142 mg 849 ± 366 ng/mL 17637 ± 7744 ng*hr/mL 190 mg 811 ± 300 ng/mL 15339 ± 6935 ng*hr/mL Abbreviations: C max = maximum concentration; AUC = area under the time concentration curve Table 12: Nilotinib predicted mean ±SD steady-state exposure in fasted patients receiving the DANZITEN approved recommended dosages DANZITEN Dosage C max,ss AUC ss 142 mg twice daily 2071 ± 761 ng/mL 14525 ± 5690 ng*hr/mL 190 mg twice daily 2229 ± 790 ng/mL 15662 ± 5738 ng*hr/mL Abbreviations: C max,ss = maximum concentration; AUC ss = area under the time concentration curve at steady state Absorption The median time (range) to reach peak plasma nilotinib concentrations (T max ) is 2.7 (1.0 to 4.7 hours) following single dose administration of DANZITEN 190 mg in fasted healthy subjects.

Effect of Food No clinically significant differences in nilotinib exposure were observed following administration of DANZITEN 142 mg or 190 mg with a high-fat meal (800 to 1000 calories, 50% fat) or a low-fat meal (400-500 kcal, 25% fat content) compared to fasted healthy subjects. Distribution Serum protein binding is approximately 98% with a blood-to-serum ratio of 0.68. Elimination The mean elimination half-life of nilotinib is approximately 14 hours.

Metabolism Nilotinib is primarily metabolized via CYP3A4-mediated oxidation and to a minor extent by CYP2C8. Excretion After a single dose of radiolabeled nilotinib, more than 90% of the administered dose was eliminated within 7 days: 93% of the dose in feces. Parent drug accounted for 69% of the dose.

Specific Populations N… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 107 words ▾

12.1Mechanism of Action Nilotinib is an inhibitor of the BCR-ABL kinase. Nilotinib binds to and stabilizes the inactive conformation of the kinase domain of ABL protein. In vitro, nilotinib inhibited BCR-ABL mediated proliferation of murine leukemic cell lines and human cell lines derived from patients with Ph+ CML.

Under the conditions of the assays, nilotinib was able to overcome imatinib resistance resulting from BCR-ABL kinase mutations, in 32 out of 33 mutations tested. Nilotinib inhibited the autophosphorylation of the following kinases at IC50 values as indicated: BCR-ABL (20 to 60 nM), PDGFR (69 nM), c-KIT (210 nM), CSF-1R (125 to 250 nM), and DDR1 (3.7 nM).

📦 How Supplied / Storage and Handling 132 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING DANZITEN (nilotinib) 71 mg tablets are pink, coated, oblong tablets, debossed with “N5” on one side and plain on other side. DANZITEN (nilotinib) 95 mg tablets are yellow, coated, oblong tablets, debossed with “N2” on one side and plain on other side. DANZITEN (nilotinib) 71 mg and 95 mg tablets are supplied in blister packs.

71 mg Outer Carton containing 4 inner carton packs (4x28)...............................NDC 24338-154-01 Inner carton containing 2 blister packs (2x14)..........................................NDC 24338-154-02 Blisters of 14 tablets (1x14)......................................................................NDC 24338-154-03 95 mg Outer Carton containing 4 inner carton packs (4x28)...............................NDC 24338-155-01 Inner carton containing 2 blister packs (2x14)..........................................NDC 24338-155-02 Blisters of 14 tablets (1x14)......................................................................NDC 24338-155-03 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 156 words ▾

11 DESCRIPTION DANZITEN (nilotinib) tablets contain nilotinib, a kinase inhibitor. Nilotinib is present as nilotinib tartrate, with the molecular formula of C 28 H 22 F 3 N 7 O . C 4 H 6 O 6 and a weight of 679.61 g/mol.

Nilotinib tartrate is a white to slightly yellowish powder. The solubility of nilotinib tartrate in aqueous solutions decreases with increasing pH. The pK a 1 was determined to be 3.53; pK a 2 was estimated to be 1.55.

The chemical name of nilotinib tartrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]benzamide,(2R,3R)-2,3-dihydroxybutanedionate. Its structure is shown below: DANZITEN (nilotinib) tablets contain 71 mg or 95 mg nilotinib, equivalent to 91.14 mg, and 121.95 mg nilotinib tartrate, respectively. The inactive ingredients are: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, iron oxide red (in 71 mg strength tablets), iron oxide yellow (in 95 mg strength tablets), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Danziten structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Taking DANZITEN Advise patients that DANZITEN may not be substitutable, on a milligram per milligram basis, with other nilotinib products. Advise patients to take DANZITEN exactly as prescribed [see Warnings and Precautions ( 5.1 )] .

Advise patients to take DANZITEN doses twice daily approximately 12 hours apart. Advise patients to swallow the tablets whole with water and not to cut, crush, or chew the tablets. Advise patients to take DANZITEN with or without food.

Patients should not consume grapefruit products and other foods that are known to inhibit CYP3A4 at any time during DANZITEN treatment [see Dosage and Administration ( 2.2 ), Drug Interactions ( 7.1 )] . If the patient misses a dose of DANZITEN, the patient should take the next scheduled dose at its regular time. The patient should not take two doses at the same time.

Compliance Advise patients of the following: • Continue taking DANZITEN every day for as long as their doctor tells them. • This is a long-term treatment. • Do not change dose or stop taking DANZITEN without first consulting their doctor. Myelosuppression Advise patients that treatment with nilotinib can cause serious thrombocytopenia, neutropenia, and anemia. Advise patients to seek immediate medical attention if symptoms suggestive of low blood counts occur, such as fever, chills or other signs of infection, unexplained bleeding or bruising, or unexplained weakness or shortness of breath [see Warnings and Precautions ( 5.2 )].

QT Prolongation Advise patients that nilotinib can cause possibly life-threatening, abnormal heartbeat. Advise patients to seek immediate medical attention if symptoms of abnormal heartbeat occur, such as feeling light-headed, faint or experiencing an irregular heartbeat [see Warnings and Precautions ( 5.3 )]. Cardiac and Arterial Vascular Occlusive Events Advise patients that cardiovascular events (including ischemic heart disease, peripheral arterial occlusive disease, and ischemic cerebrovascular events) have been reported.

Advise patients to seek immediate medical attention if any symptoms suggestive of a cardiovascular event occur, such as chest or leg pain, numbness or weakness, or problems walking or speaking occur suddenly [see Warnings and Precautions ( 5.5 )]. Pancreatitis and Elevated Serum Lipase Advise patients that nilotinib can increase the risk of pancreatitis and that patients with a previous history of pancreatitis may be at greater risk. Advise patients to seek immediate medical attention if symptoms suggestive of pancreatitis occur, such as sudden stomach area pain with accompanying nausea and vomiting [see Warnings and Precautions ( 5.6 )].

Hepatotoxicity Advise patients that nilotinib can increase the risk of hepatotoxicity and that patients with previous history of liver diseases may be at risk. Advise patients to seek immediate medical attention if any symptoms suggestive of hepatotoxicity occur, such as stomach pain, yellow skin and eyes, and dark-colored urine [see Warnings and Precautions ( 5.7 )] . Tumor Lysis Syndrome Advise patients that nilotinib can cause TLS and to seek immediate medical attention if any symptoms suggestive of TLS occur, such as an abnormal heartbeat or less urine production [see Warnings and Precautions ( 5.9 )] .

Hemorrhage Advise patients that serious hemorrhagic events, including fatal events, have occurred in patients with CML treated with nilotinib. Advise patients to seek immediate medical attention if symptoms suggestive of hemorrhage occur, such as uncontrolled bleeding, changes in eyesight, unconsciousness, or sudden headache or sudden confusion in surroundings [see Warnings and Precautions ( 5.10 )] . Fluid Retention Advise patients that nilotinib can cause fluid retention and to seek immediate medical attention if any symptoms suggestive of fluid retention, such as shortness of breath, rapid weight gain… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Nilotinib single-dose maximum concentration (Cmax), area under the time concentration curve (AUC), predicted steady-state maximum concentration (Cmax,ss) and area under the time concentration curve (AUCss) in fasted subjects receiving the DANZITEN approved recommended dosages are presented in Tables 11 and 12. Table 11: Nilotinib mean ±SD single-dose exposure in fasted patients receiving the DANZITEN approved recommended dosages DANZITEN Dosage C max AUC 142 mg 849 ± 366 ng/mL 17637 ± 7744 ng*hr/mL 190 mg 811 ± 300 ng/mL 15339 ± 6935 ng*hr/mL Abbreviations: C max = maximum concentration; AUC = area under the time concentration curve Table 12: Nilotinib predicted mean ±SD steady-state exposure in fasted patients receiving the DANZITEN approved recommended dosages DANZITEN Dosage C max,ss AUC ss 142 mg twice daily 2071 ± 761 ng/mL 14525 ± 5690 ng*hr/mL 190 mg twice daily 2229 ± 790 ng/mL 15662 ± 5738 ng*hr/mL Abbreviations: C max,ss = maximum concentration; AUC ss = area under the time concentration curve at steady state Absorption The median time (range) to reach peak plasma nilotinib concentrations (T max ) is 2.7 (1.0 to 4.7 hours) following single dose administration of DANZITEN 190 mg in fasted healthy subjects.

Effect of Food No clinically significant differences in nilotinib exposure were observed following administration of DANZITEN 142 mg or 190 mg with a high-fat meal (800 to 1000 calories, 50% fat) or a low-fat meal (400-500 kcal, 25% fat content) compared to fasted healthy subjects. Distribution Serum protein binding is approximately 98% with a blood-to-serum ratio of 0.68. Elimination The mean elimination half-life of nilotinib is approximately 14 hours.

Metabolism Nilotinib is primarily metabolized via CYP3A4-mediated oxidation and to a minor extent by CYP2C8. Excretion After a single dose of radiolabeled nilotinib, more than 90% of the administered dose was eliminated within 7 days: 93% of the dose in feces. Parent drug accounted for 69% of the dose.

Specific Populations No clinically significant differences in the pharmacokinetic of nilotinib were observed based on age, sex, race/ethnicity, or body weight. The effect of renal impairment on nilotinib pharmacokinetics is unknown. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s Tasigna® (nilotinib) capsules.

However due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Patients with Hepatic Impairment Nilotinib mean AUC increased 1.4-fold in mild (Child-Pugh class A), 1.4-fold in moderate (Child-Pugh class B), and 1.6-fold in severe (Child-Pugh class C) hepatic impairment subjects following a single equivalent recommended dose of DANZITEN 95 mg (66% of the lowest approved recommended dosage). Drug Interaction Studies Clinical Studies Strong CYP3A Inhibitors : Nilotinib AUC increased by approximately 3-fold following concomitant administration of ketoconazole (strong CYP3A inhibitor) 400 mg once daily for 6 days.

Nilotinib AUC increased by 1.3-fold with concomitant use with double-strength grapefruit juice. Strong CYP3A Inducers : Nilotinib AUC decreased by approximately 80% following concomitant use with rifampicin (strong CYP3A inducer) 600 mg daily. Proton Pump Inhibitors (PPIs) : Nilotinib displays pH-dependent aqueous solubility [see Description (11)].

Nilotinib AUC decreased by 34% following concomitant use of multiple doses of esomeprazole (PPI) 40 mg daily. Other Drugs : No clinically significant differences in nilotinib pharmacokinetics were observed when used concomitantly with imatinib (moderate CYP3A inhibitor), famotidine (an H2 blocker), or an antacid. No clinically significant differences in the pharmacokinetics of the following drugs were observed when used concomitantly with nilotinib; oral midazolam (CYP3A substrate), imatinib, or warfarin (CYP2C9 substrate).

In Vitro Studies Where Drug Interaction… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 188 words ▾

12.2Pharmacodynamics A relationship between nilotinib exposure and a greater likelihood of response and safety events, including a higher occurrence of total bilirubin elevations, was observed in clinical studies. Nilotinib time course of pharmacodynamic response is unknown. Cardiac Electrophysiology Nilotinib is associated with concentration-dependent QT prolongation.

At the equivalent recommended dosage of DANZITEN 190 mg twice daily given without food in healthy subjects, the maximum mean placebo-adjusted QTcF changes were 10.4 msec (90% CI: 2.85, 18.0). After a single equivalent recommended dose of DANZITEN 380 mg (two times the maximum approved recommended dose) given with a high fat meal to healthy subjects, the maximum mean placebo-adjusted QTcF changes were) 18.0 msec (90% CI: 9.65, 25.8). Peak plasma concentrations in the QT study were 26% lower than or comparable with those observed in patients enrolled in the single-arm study [see Boxed Warning, Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 )] .

No new significant QT findings were observed in healthy subject studies with single doses of DANZITEN given with or without food. Throughout the 14 PK studies there were no QT prolongation events associated with DANZITEN.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Adult Newly Diagnosed Ph+ CML-CP The effectiveness of 142 mg twice daily of DANZITEN (nilotinib) tablets for the treatment of adult patients with newly diagnosed Ph+ CML-CP has been established from an adequate and well-controlled study of Tasigna ® (nilotinib) capsules, which has a different recommended dosage than DANZITEN. Below is a display of the results of Tasigna ® (nilotinib) capsules in this adequate and well-controlled study. The ENESTnd (Evaluating Nilotinib Efficacy and Safety in clinical Trials-Newly Diagnosed patients) study (NCT00471497) was an open-label, multicenter, randomized trial conducted to determine the efficacy of nilotinib versus imatinib in adult patients with cytogenetically confirmed newly diagnosed Ph+ CML-CP.

Patients were within 6 months of diagnosis and were previously untreated for CML-CP, except hydroxyurea and/or anagrelide. Efficacy was based on a total of 846 patients: 283 patients in the imatinib 400 mg once daily group, 282 patients in the nilotinib dosage equivalent to DANZITEN 142 mg twice daily group, 281 patients in the nilotinib dosage equivalent to DANZITEN 190 mg twice daily group (an unapproved dosage regimen for this indication). Median age was 46 years in the imatinib group and 47 years in the nilotinib group, with 12% and 13% of patients greater than or equal to 65 years of age in imatinib 400 mg once daily and nilotinib dosage equivalent to DANZITEN 142 mg twice daily treatment groups, respectively.

There were slightly more male than female patients in all groups (56% and 56%, in imatinib 400 mg once daily and nilotinib dosage equivalent to DANZITEN 142 mg twice daily treatment groups). Approximately 60% of all patients were White, and 25% were Asian. The primary data analysis was performed when all 846 patients completed 12 months of treatment (or discontinued earlier).

Subsequent analyses were done when patients completed 24, 36, 48, and 60 months of treatment (or discontinued earlier). The median time on treatment was approximately 61 months in all three treatment groups. The primary efficacy endpoint was major molecular response (MMR) at 12 months after the start of study medication.

MMR was defined as less than or equal to 0.1% BCR-ABL/ABL % by international scale measured by RQ-PCR, which corresponds to a greater than or equal to 3 log reduction of BCR-ABL transcript from standardized baseline. Efficacy endpoints are summarized in Table 13. Two patients in the nilotinib arm progressed to either accelerated phase or blast crisis (both within the first 6 months of treatment) while 12 patients on the imatinib arm progressed to either accelerated phase or blast crisis (7 patients within first 6 months, 2 patients within 6 to 12 months, 2 patients within 12 to 18 months and 1 patient within 18 to 24 months).

Table 13. Efficacy (MMR and CCyR) of Nilotinib Compared to imatinib in Adult Newly Diagnosed Ph+ CML-CP (ENESTnd) Nilotinib 300 mg Twice Daily* Imatinib 400 mg Once Daily N = 282 N = 283 MMR at 12 months (95% CI) 44% (38.4, 50.3) 22% (17.6, 27.6) P-Value a < 0.0001 CCyRb by 12 months (95% CI) 80% (75.0, 84.6) 65% (59.2, 70.6) MMR at 24 months (95% CI) 62% (55.8, 67.4) 38% (31.8, 43.4) CCyRb by 24 months (95% CI) 87% (82.4, 90.6) 77% (71.7, 81.8) Abbreviation: CI, confidence interval. * Equivalent to DANZITEN 142 mg twice daily. a CMH test stratified by Sokal risk group. b CCyR: 0% Ph+ metaphases.

Cytogenetic responses were based on the percentage of Ph+ metaphases among greater than or equal to 20 metaphase cells in each bone marrow sample. By 60 months, MMR was achieved by 77% of patients on nilotinib and 60% of patients on imatinib; MR4.5 was achieved by 53.5% of patients on nilotinib and 31.4% on imatinib. Median overall survival was not reached in either arm.

At the time of the 60-month final analysis, the estimated survival rate was 93.7% for patients on nilotinib and 91.7% for patients on imatinib.

14.2Adult Patients with Resistant or Into… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility A 2-year carcinogenicity study was conducted orally in rats at nilotinib doses of 5, 15, and 40 mg/kg/day. Exposures in animals at the highest dose tested were approximately 2- to 3-fold the human exposure (based on AUC) at the nilotinib dose of 400 mg twice daily. The study was negative for carcinogenic findings.

A 26-week carcinogenicity study was conducted orally in Tg.rasH2 mice, a model genetically modified to enhance susceptibility to neoplastic transformation, at nilotinib doses of 30, 100, and 300 mg/kg/day. Nilotinib induced in the skin and subcutis statistically significant increases in the incidence of papillomas in females and of papillomas and combined papillomas and carcinomas in males at 300 mg/kg/day. The no-observed-adverse- effect-level (NOAEL) for skin neoplastic lesions was 100 mg/kg/day.

Nilotinib was not mutagenic in a bacterial mutagenesis (Ames) assay, was not clastogenic in a chromosome aberration assay in human lymphocytes, did not induce DNA damage (comet assay) in L5178Y mouse lymphoma cells, nor was it clastogenic in an in vivo rat bone marrow micronucleus assay with two oral treatments at doses up to 2000 mg/kg/dose. There were no effects on male or female rat and female rabbit mating or fertility at doses up to 180 mg/kg in rats (approximately 4- to 7-fold for males and females, respectively, the AUC in patients at the dose of 400 mg twice daily) or 300 mg/kg in rabbits (approximately one-half the AUC in patients at the dose of 400 mg twice daily).

The effect of nilotinib on human fertility is unknown. In a study where male and female rats were treated with nilotinib at oral doses of 20 to 180 mg/kg/day (approximately 1- to 6.6-fold the AUC in patients at the dose of 400 mg twice daily) during the pre-mating and mating periods and then mated, and dosing of pregnant rats continued through gestation Day 6, nilotinib increased post-implantation loss and early resorption, and decreased the number of viable fetuses and litter size at all doses tested.

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

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility A 2-year carcinogenicity study was conducted orally in rats at nilotinib doses of 5, 15, and 40 mg/kg/day. Exposures in animals at the highest dose tested were approximately 2- to 3-fold the human exposure (based on AUC) at the nilotinib dose of 400 mg twice daily. The study was negative for carcinogenic findings.

A 26-week carcinogenicity study was conducted orally in Tg.rasH2 mice, a model genetically modified to enhance susceptibility to neoplastic transformation, at nilotinib doses of 30, 100, and 300 mg/kg/day. Nilotinib induced in the skin and subcutis statistically significant increases in the incidence of papillomas in females and of papillomas and combined papillomas and carcinomas in males at 300 mg/kg/day. The no-observed-adverse- effect-level (NOAEL) for skin neoplastic lesions was 100 mg/kg/day.

Nilotinib was not mutagenic in a bacterial mutagenesis (Ames) assay, was not clastogenic in a chromosome aberration assay in human lymphocytes, did not induce DNA damage (comet assay) in L5178Y mouse lymphoma cells, nor was it clastogenic in an in vivo rat bone marrow micronucleus assay with two oral treatments at doses up to 2000 mg/kg/dose. There were no effects on male or female rat and female rabbit mating or fertility at doses up to 180 mg/kg in rats (approximately 4- to 7-fold for males and females, respectively, the AUC in patients at the dose of 400 mg twice daily) or 300 mg/kg in rabbits (approximately one-half the AUC in patients at the dose of 400 mg twice daily).

The effect of nilotinib on human fertility is unknown. In a study where male and female rats were treated with nilotinib at oral doses of 20 to 180 mg/kg/day (approximately 1- to 6.6-fold the AUC in patients at the dose of 400 mg twice daily) during the pre-mating and mating periods and then mated, and dosing of pregnant rats continued through gestation Day 6, nilotinib increased post-implantation loss and early resorption, and decreased the number of viable fetuses and litter size at all doses tested.

📄 Package Label / Principal Display Panel 101 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 24338-154-01 DANZITEN (nilotinib) tablets 71 mg - Outer Carton Label Outer Carton containing 4 inner carton packs (4x28) 71 mg per tablet NDC 24338-154-02 DANZITEN (nilotinib) tablets 71 mg - Inner Carton Label Carton of 2 blister packs (2x14) 71 mg per tablet Package Label Principal Display Panel NDC 24338-155-01 DANZITEN (nilotinib) tablets 95 mg - Outer Carton Label Outer Carton containing 4 inner carton packs (4x28) 95 mg per tablet NDC 24338-155-02 DANZITEN (nilotinib) tablets 95 mg - Inner Carton Label Carton of 2 blister packs (2x14) 95 mg per tablet outer-carton-71mg inner-carton-71mg outer-carton-95mg inner-carton-95mg

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

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 this package alone, 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 – Q1 2026 · 5 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
15
Units reimbursed last 4 qtrs
1.7K
Gross reimbursed last 4 qtrs
$270.5K
Avg / prescription
$18,035.68
Avg / unit
$161.03
Latest quarter Q1 2026
0Rx
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 15 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 1,680 units · 4.3 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.34.3
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 California 4.3 /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.

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

Medicare Part D (outpatient prescription) spending for Danziten — 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 Danziten. 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
$4.14M
Claims incl. refills
271
Beneficiaries
120
Spend / beneficiary
$34,465.81
Spend / claim
$15,261.61
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.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Azurity Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Azurity Pharmaceuticals, 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.
← 24338-0153-02 · Azurity 24338-0155-01 · Azurity →
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.