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Harliku nitisinone 2 mg Tablet, 60-count — NDC 70709-0112-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Harliku nitisinone 2 mg Tablet, 60-count — NDC 70709-112-60 (Billing 70709-0112-60)

by Cycle Pharmaceuticals Ltd. · 1 BOTTLE, PLASTIC in 1 CARTON / 60 TABLET in 1 BOTTLE, PLASTIC

This is a package of 60 tablets of Harliku nitisinone 2 mg Tablet from Cycle Pharmaceuticals Ltd., marketed since Jul 2025 and currently FDA-listed. It is this product's only package size.

NDC 70709-0112-60
🏷️ FDA NDC (as labeled) 70709-112-60 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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 70709-112-60 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70709 labeler · 112 product · 60 package
Package marketed since
Jul 21, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
60 EA per package
Barcode (UPC)
0370709112602
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70709-112-60
Product NDC 70709-112
11-digit billing NDC 70709011260
NCPDP billing unit EA — each (per item)
RxCUI 1941474, 2719722
UNII K5BN214699
UPC 0370709112602
Application # NDA209449
SPL Set ID 7cf67e24-d46b-4376-bbd0-0b973c406d0d
Established class (EPC) 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor
Mechanism of action Hydroxyphenylpyruvate Dioxygenase Inhibitors; Cytochrome P450 2C9 Inhibitors; Cytochrome P450 2E1 Inducers; Organic Anion Transporter 1 Inhibitors; Organic Anion Transporter 3 Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-07-21
Route ORAL
Dosage form TABLET
Substance NITISINONE

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

GPI-14 30902255000310
GCN Seq No 077108
GCN 43006
HICL code 023253
Ingredient (HICL) Nitisinone
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D7
Therapeutic class — intermediate (HIC2) Act Primarily On Liver/Biliary Tract
HIC3 code D7D
Therapeutic class — specific (HIC3) Hydroxyphenyl-Pyruvate Dioxygenase(Hppd) Inhibitor
AHFS code 44:08.00.00
AHFS class Enzyme Cofactors/Chaperones
FDB label name HARLIKU 2 MG TABLET
FDB brand name Harliku
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 077108
  • GCN: 43006
  • GPI-14 (Medi-Span): 30902255000310
  • HICL (First Databank): 023253
  • AHFS class code: 44:08.00.00
  • RxCUI (RxNorm): 1941474
Why two NDCs? The FDA registers this code as 70709-112-60 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 70709-0112-60. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor class.

Pharmacologic class 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor
Drug family (ATC) Various alimentary tract and metabolism products
How it works Hydroxyphenylpyruvate Dioxygenase Inhibitors, Cytochrome P450 2C9 Inhibitors, Organic Anion Transporter 1 Inhibitors, Organic Anion Transporter 3 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 HARLIKU 2 MG TABLET Ingredient Nitisinone
📖 What it is MedlinePlus · NLM

Nitisinone is used to treat hereditary tyrosinemia type 1 (HT-1; rare genetic disorder where body cannot break down amino acid tyrosine causing build-up that can harm kidneys and liver) and reduction of urine homogentisic acid (HGA) in patients with alkaptonuria (AKU; rare genetic disorder where body can't breakdown aminoacids tyrosine and phenylalanine leading to builld up of HGA causing deposits in connective tissue causing severe arthritis symptoms). Nitisinone is in a class of medications called hydroxyphenyl-pyruvate dioxygenase inhibitors. It works by by helping the body eliminate the to...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Nitisinone works by blocking a step in the breakdown of tyrosine — an amino acid found in many protein-rich foods. This means tyrosine can build up in your blood while you're on th...
  • Why do I have to follow a special diet while taking nitisinone?
  • High tyrosine levels can irritate and damage the surface of your eyes. Call your doctor right away if you notice eye pain, increased sensitivity to light, redness, swelling, or any...
  • What eye problems should I watch out for, and when should I call my doctor?
📖 Read our full Nitisinone 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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $1,481.43 $88,885.81 / 60 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
70709-0112-60 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 60 TABLET in 1 BOTTLE, PLASTIC 2025-07-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nityr 2 mg 70709-0002-60 Cycle 60 tablets — — FDA listed —
Harliku 2 mgthis 70709-0112-60 Cycle 60 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

🏛️
2025
First FDA approval
Jun 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2035
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 Jan 2035. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jun 10, 2025 RLD RS ⏳ ~8.2 yr to latest listed protection

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

Patents & exclusivity — FDA Orange Book
US 10328029 — method of use (U-1836)
US 10328029 — method of use (U-1836)
US 10328029 — method of use (U-1836)
Exclusivity ODE-529
2025 2027 2029 2031 2033 2035
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 (3)
PatentTypeUse codeExpires
US 10328029 ↗ Method of use U-1836 Jan 5, 2035
US 10328029 ↗ Method of use U-1836 Jan 5, 2035
US 10328029 ↗ Method of use U-1836 Jan 5, 2035
FDA exclusivity
CodeWhat it grantsExpires
ODE-529Orphan Drug Exclusivity (7-year)Jun 10, 2032
Common questions
Is there a generic version of HARLIKU 2 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for HARLIKU 2 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jan 2035 — 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.

What it looks like

Color white
ShapeRound
ImprintL;2
Size7 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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

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

  • UNII R8WTH25YS2
    Glyceryl dibehenate is a wax-like substance made from behenate fatty acids and glycerol. It functions as a binder and release-control agent in tablets and capsules, helping hold ingredients together and regulate how quickly the medicine dissolves and releases in your body.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerCycle Pharmaceuticals Ltd.
Application holderCYCLE PHARMACEUTICALS LTD
FDA applicationNDA209449 (NDA)
Labeler code70709
First marketedJul 2025
Product typeHuman Prescription Drug
Portfolio8 products on file

More NDCs from Cycle Pharmaceuticals Ltd. labeler code 70709

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

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 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
🎯 Indications and Usage 46 words ▾

1 INDICATIONS AND USAGE HARLIKU TM is indicated for the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU). HARLIKU is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated for the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU). ( 1 )

⏱️ Dosage and Administration 78 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage of HARLIKU is 2 mg administered orally, once daily. ( 2.1 )

2.1Recommended Dosage The recommended dosage of HARLIKU is 2 mg administered orally, once daily. Administer HARLIKU with or without food [see Clinical Pharmacology ( 12.3 )] . Missed Dose If a dose of HARLIKU is missed, do not administer two doses at once to make up for a missed dose. Take the next dose at the scheduled time.

💊 Dosage Forms and Strengths 41 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 2 mg white to beige, round, flat tablets, which may display light yellow to brown speckles, debossed with “2” mg on one side and “L” on the other side. Tablets: 2 mg. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Ocular Symptoms and Hyperkeratotic Plaques Due To Elevated Plasma Tyrosine Levels : Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine and levels above 500 micromol/L may lead to ocular signs and symptoms or painful hyperkeratotic plaques on the soles and palms. ( 5.1 ) Assess plasma tyrosine levels in patients presenting with ocular signs and symptoms. ( 5.1 ) Obtain slit-lamp examination prior to treatment and regularly thereafter.

( 5.1 ) Implement diet restriction and/or treatment interruption as appropriate. ( 5.1 ) Leukopenia and Severe Thrombocytopenia: Monitor platelet and white blood cell counts. ( 5.2 )

5.1Ocular Symptoms and Hyperkeratotic Plaques Due to Elevated Plasma Tyrosine Levels Treatment with HARLIKU may cause elevated plasma tyrosine levels in patients with AKU. Tyrosine levels greater than 500 micromol/L may lead to the following: Ocular signs and symptoms including keratitis, corneal opacities, corneal irritation, corneal ulcers, conjunctivitis, eye pain, and photophobia. These ocular adverse reactions have been reported in patients treated with nitisinone [see Adverse Reactions ( 6.1 )] .

In a clinical trial in the AKU population, without dietary restriction and reported tyrosine levels > 500 micromol/L, both symptomatic and asymptomatic keratopathies have been observed. Perform a baseline ophthalmologic examination including slit-lamp examination prior to initiating HARLIKU treatment and regularly thereafter. Patients who develop photophobia, eye pain, or signs of inflammation such as redness, swelling, or burning of the eyes or tyrosine levels are > 500 micromol/L during treatment with HARLIKU should undergo slit-lamp re-examination and immediate measurement of the plasma tyrosine concentration.

Painful hyperkeratotic plaques on the soles and palms. There is no routine dietary restriction requirement for AKU patients taking HARLIKU. However, in patients who develop keratopathies, monitor plasma tyrosine levels, and implement a diet restricted in tyrosine and phenylalanine to keep the plasma tyrosine level below 500 micromol/L.

Consider temporarily interrupting HARLIKU until resolution of symptoms.

5.2Leukopenia and Severe Thrombocytopenia In clinical trials, patients with hereditary tyrosinemia type 1 (HT-1) treated with another oral formulation of nitisinone and dietary restriction developed reversible leukopenia (3%), thrombocytopenia (3%), or both (1.5%). Ten percent of patients in Trial 1 developed thrombocytopenia [see Adverse Reactions ( 6.1 )] . No patients developed infections or bleeding as a result of the episodes of leukopenia and thrombocytopenia.

Monitor platelet and white blood cell counts during HARLIKU therapy.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions (>1%) are elevated tyrosine levels, keratitis and thrombocytopenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals Ltd at 1-855-831-5413 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Serious and/or clinically significant adverse reactions described elsewhere in labeling include: Ocular Symptoms and Hyperkeratotic Plaques Due to Elevated Plasma Tyrosine Levels [see Warnings and Precautions ( 5.1 )] Leukopenia and Severe Thrombocytopenia [see Warnings and Precautions ( 5.2 )]

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 HARLIKU was evaluated in Trial 1, a three-year, open-label, randomized, no-treatment controlled trial in 40 patients with AKU. Patients were between 38 and 68 years of age (27 male, 13 female) [see Clinical Studies ( 14 )] .

Patients received either HARLIKU 2 mg orally once daily or no treatment [see Dosage and Administration ( 2 )]. The serious adverse reactions reported with HARLIKU were ocular/visual complaints associated with elevated tyrosine levels (keratitis) [see Warnings and Precautions ( 5.1 )] . Keratitis led to permanent treatment discontinuation in 1 (5%) treated patient.

The most common adverse reactions (>1%) reported in Trial 1 are summarized in TABLE 1. TABLE 1. Most Common Adverse Reactions* in Patients with AKU Treated with Nitisinone** Adverse Reactions Nitisinone (N=20) n (%) No Treatment (N=20) n (%) Elevated tyrosine levels 19 (95) 0 (0) Keratitis*** 3 (15) 0 (0) Thrombocytopenia 2 (10) 0 (0) * reported in at least 1% of patients; ** another oral formulation of nitisinone; *** keratitis also includes eye irritation, eye pain and photophobia.

🔄 Drug Interactions 173 words ▾

7 DRUG INTERACTIONS Sensitive CYP2C9 Substrates: Reduce dosage of co-administered drug metabolized by CYP2C9 by half. ( 7.1 ) OAT1/OAT3 Substrates : Avoid concomitant use of HARLIKU with OAT1/OAT3 substrates. Concomitant use with OAT1/OAT3 substrates may increase the risk of adverse reactions related to the co-administered drug. ( 7.1 )

7.1Effects of HARLIKU on Other Drugs Sensitive CYP2C9 Substrates Reduce the dosage of the co-administered drug metabolized by CYP2C9 by half. Additional dosage adjustments may be needed to maintain therapeutic drug concentrations where minimal concentration changes may lead to serious adverse reactions. See prescribing information for those drugs.

Nitisinone is a moderate CYP2C9 inhibitor. Nitisinone may increase exposure of co-administered drugs metabolized by CYP2C9 [see Clinical Pharmacology ( 12.3 )] . OAT1/OAT3 Substrates The concomitant use of HARLIKU with OAT1/OAT3 substrates may increase the risk of adverse reactions related to the co-administered drug.

See prescribing information for those drugs. Nitisinone is an OAT1/OAT3 inhibitor which can lead to increased exposure of the co-administered drug. [ see Clinical Pharmacology ( 12.3 )] .

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data from published case reports with nitisinone use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Animal reproduction studies have been conducted for nitisinone. In these studies, nitisinone was administered to mice and rabbits during organogenesis with oral doses of nitisinone up to 600 and 240 times respectively, the maximum recommended human daily dose (MRHDD) of 2 mg/day.

In mice, nitisinone caused incomplete skeletal ossification of fetal bones and decreased pup survival at doses 12 times the MRHDD, and increased gestational length at doses 120 times the MRHDD. In rabbits, nitisinone caused maternal toxicity and incomplete skeletal ossification of fetal bones at doses 48 times the MRHDD ( 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 defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In an embryo-fetal development study in mice, nitisinone was administered via oral gavage to pregnant mice at dose levels of 12, 120 and 600 times the maximum recommended human daily dose (MRHDD) of 2 mg/day.

Nitisinone caused incomplete skeletal ossification of fetal bones and decreased pup survival at doses 12 times the MRHDD and increased gestational length at doses 120 times the MRHDD. In an embryo-fetal development study in rabbits, nitisinone was administered via oral gavage to pregnant rabbits at dose levels of 48, 120 and 240 times the MRHDD of 2 mg/day. Nitisinone caused maternal toxicity and incomplete skeletal ossification of fetal bones at doses 48 times the MRHDD.

In a single dose-group study in rats given 100 mg/kg (486 times the MRHDD of 2 mg/day), reduced litter size, decreased pup weight at birth, and decreased survival of pups after birth was demonstrated.

8.2Lactation Risk Summary There are no data on the presence of nitisinone in human milk, the effects on the breastfed infant, or the effects on milk production. Data suggest that nitisinone is present in rat milk due to findings of ocular toxicity and lower body weight seen in drug naive nursing rat pups. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for HARLIKU and any potential adverse effects on the breastfed infant from HARLIKU or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of HARLIKU have not been established in pediatric patients with AKU.

8.5Geriatric Use There was 1 patient 65 years of age and older in the clinical studies for AKU [see Clinical Studies ( 14 )] . Of the total number of HARLIKU-treated patients in these studies, 1 (2.5 %) were 65 years of age and older, while 0 (0%) were 75 years of age and older. Clinical studies of HARLIKU did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Available data from published case reports with nitisinone use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Animal reproduction studies have been conducted for nitisinone. In these studies, nitisinone was administered to mice and rabbits during organogenesis with oral doses of nitisinone up to 600 and 240 times respectively, the maximum recommended human daily dose (MRHDD) of 2 mg/day.

In mice, nitisinone caused incomplete skeletal ossification of fetal bones and decreased pup survival at doses 12 times the MRHDD, and increased gestational length at doses 120 times the MRHDD. In rabbits, nitisinone caused maternal toxicity and incomplete skeletal ossification of fetal bones at doses 48 times the MRHDD ( 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 defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In an embryo-fetal development study in mice, nitisinone was administered via oral gavage to pregnant mice at dose levels of 12, 120 and 600 times the maximum recommended human daily dose (MRHDD) of 2 mg/day.

Nitisinone caused incomplete skeletal ossification of fetal bones and decreased pup survival at doses 12 times the MRHDD and increased gestational length at doses 120 times the MRHDD. In an embryo-fetal development study in rabbits, nitisinone was administered via oral gavage to pregnant rabbits at dose levels of 48, 120 and 240 times the MRHDD of 2 mg/day. Nitisinone caused maternal toxicity and incomplete skeletal ossification of fetal bones at doses 48 times the MRHDD.

In a single dose-group study in rats given 100 mg/kg (486 times the MRHDD of 2 mg/day), reduced litter size, decreased pup weight at birth, and decreased survival of pups after birth was demonstrated.

🧒 Pediatric Use 18 words ▾

8.4Pediatric Use The safety and effectiveness of HARLIKU have not been established in pediatric patients with AKU.

🧓 Geriatric Use 83 words ▾

8.5Geriatric Use There was 1 patient 65 years of age and older in the clinical studies for AKU [see Clinical Studies ( 14 )] . Of the total number of HARLIKU-treated patients in these studies, 1 (2.5 %) were 65 years of age and older, while 0 (0%) were 75 years of age and older. Clinical studies of HARLIKU did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Nitisinone is a competitive inhibitor of hydroxyphenyl-pyruvate dioxygenase, an enzyme upstream of homogentisate 1,2-dioxygenase (HGD) in the tyrosine catabolic pathway.

12.2Pharmacodynamics In patients with AKU, HGA accumulates in various tissues and urine. In an open-label, single center, randomized, no-treatment controlled trial nitisinone treatment resulted in reduction of urinary HGA concentrations in patients with AKU [see Clinical Studies ( 14 )]. Nitisinone exposure-response relationship and time course of pharmacodynamic response for the effectiveness have not been fully characterized.

Nitisinone inhibits catabolism of the amino acid tyrosine and can result in elevated plasma levels of tyrosine in patients with AKU. Treatment with nitisinone does not require routine dietary restriction in patients with AKU; however, patients who develop keratopathies should be monitored and dietary restriction of tyrosine and phenylalanine should be implemented [see Warnings and Precautions ( 5.1 )].

12.3Pharmacokinetics The single-dose pharmacokinetics of nitisinone tablets have been studied in healthy adult subjects. Nitisinone pharmacokinetic parameters are presented as geometric mean [range] unless otherwise specified. Nitisinone maximum concentration (Cmax) and area under the curve from time 0 to 120 hours (AUC0-120h) were 1278 [780 to 1649] ng/mL and 77874 [42335 to 104211] ng•h/mL following oral administration of 10 mg (5 times the recommended dosage) nitisinone under fasting conditions.

Absorption Nitisinone time to C max (T max ) is 3.5 hours (median, ranging from 1 to 4 hours) following single oral administration of 10 mg (5 times the recommended dosage) nitisinone under fasting conditions. Effect of Food : In a food effect study, a high-fat and high-calorie breakfast (973.6 cal distributed in carbohydrate 250.1 cal, proteins 157 cal, fat 566.5 cal) did not significantly affect the total exposure (AUC 0-120h ) and C max of nitisinone following single oral administration of 10 mg nitisinone (5 times the recommended dosage).

The median T max was delayed to 6 hours under fed conditions [see Dosage and Administration ( 2 )] . Distribution The arithmetic mean (SD) apparent volume of distribution of nitisinone is 8.2 (1.6) L in healthy subjects (n=23). In vitro binding of nitisinone to human plasma proteins is greater than 95% at 50 micromolar concentration.

Elimination The arithmetic mean (SD) terminal half-life of nitisinone is 59.3 (8.9) hours in healthy subjects (n=23). The mean (CV%) apparent plasma clearance in 18 healthy adults following multiple once daily doses of nitisinone 80 mg (40 times the recommended dosage) is 113 (16) mL/hr. The mean of the fraction of dose excreted renally as unchanged nitisinone in the urine (fe(%)) was 3% (n=3) following multiple oral doses of 80 mg (40 times the recommended dosage) daily in healthy subjects.

Metabolism In vitro studies have shown that nitisinone is relatively stable in human liver microsomes with minor metabolism possibly mediated by CYP3A4 enzyme. Excretion The estimated mean (CV%) renal clearance of nitisinone was 0.003 L/h (25%). Drug Interaction Studies Clinical Studies Nitisinone does not inhibit CYP2D6.

Nitisinone is a moderate inhibitor of CYP2C9, and a weak inducer of CYP2E1 (TABLE 2). Nitisinone is an inhibitor of OAT1/3 (TABLE 2). TABLE 2.

Percent Change in AUC 0-inf and Cmax for Co-administered Drugs in the Presence of Nitisinone in 18 Healthy Subjects Co-administered Drug a Dose of Co-administered Drug (Route of Administration) Effect of Nitisinone on the Pharmacokinetics of Co-administered Drug b AUC 0-inf C max CYP2C9 Substrate Tolbutamide c 500 mg (oral) 131%↑ 16%↑ CYP2E1 Substrate Chlorzoxazone 250 mg (oral) 27%↓ 18%↓ OAT1/3 Substrate Furosemide 20 mg (intravenous) 72%↑ 12%↑ ↑= Increased; ↓= Decreased a The interacting drug was administered alone on Day 1 and together with nitisinone on Day 17. b Multiple dose… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 24 words ▾

12.1Mechanism of Action Nitisinone is a competitive inhibitor of hydroxyphenyl-pyruvate dioxygenase, an enzyme upstream of homogentisate 1,2-dioxygenase (HGD) in the tyrosine catabolic pathway.

📦 How Supplied / Storage and Handling 115 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied HARLIKU (nitisinone) tablet is white to beige, round, flat which may display light yellow to brown speckles, debossed with the “strength” in mg on one side and “L” on the other side. Each tablet contains 2 mg nitisinone. HARLIKU is supplied in a high-density polyethylene (HDPE) square bottle with a child-resistant tamper-evident polypropylene (PP) screw cap.

Each bottle contains 60 tablets. 2 mg tablets: NDC 70709-112-60 Storage and Handling Store HARLIKU tablets at room temperature between 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]. Pharmacist: Dispense in tight and light resistant container as defined in USP.

📋 Description 93 words ▾

11 DESCRIPTION HARLIKU (nitisinone) is a hydroxyphenyl-pyruvate dioxygenase inhibitor. Nitisinone occurs as a white to yellowish-white, crystalline powder. It is practically insoluble in water, soluble in 2M sodium hydroxide and in methanol, and sparingly soluble in alcohol.

The chemical name of nitisinone is 2-(2-nitro-4-trifluoromethylbenzoyl) cyclohexane-1,3-dione. The molecular formula is C 14 H 10 F 3 NO 5 and the molecular weight is 329.23. The structural formula is: Each HARLIKU (nitisinone) tablet contains 2 mg of nitisinone to be administered orally.

The inactive ingredients are glyceryl dibehenate and lactose monohydrate. Figure 1 Structural Formula

💬 Information for Patients 75 words ▾

17 PATIENT COUNSELING INFORMATION Ocular Symptoms and Hyperkeratotic Plaques Due to Elevated Plasma Tyrosine Levels Advise the patient or caregiver to report any unexplained ocular or other symptoms promptly to their healthcare provider [see Warnings and Precautions ( 5.1 )] . How Supplied/Storage and Handling Advise the patient or caregiver to store HARLIKU in the container that it is dispensed in and keep the container tightly closed [see How Supplied/Storage and Handling ( 16 )].

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics The single-dose pharmacokinetics of nitisinone tablets have been studied in healthy adult subjects. Nitisinone pharmacokinetic parameters are presented as geometric mean [range] unless otherwise specified. Nitisinone maximum concentration (Cmax) and area under the curve from time 0 to 120 hours (AUC0-120h) were 1278 [780 to 1649] ng/mL and 77874 [42335 to 104211] ng•h/mL following oral administration of 10 mg (5 times the recommended dosage) nitisinone under fasting conditions.

Absorption Nitisinone time to C max (T max ) is 3.5 hours (median, ranging from 1 to 4 hours) following single oral administration of 10 mg (5 times the recommended dosage) nitisinone under fasting conditions. Effect of Food : In a food effect study, a high-fat and high-calorie breakfast (973.6 cal distributed in carbohydrate 250.1 cal, proteins 157 cal, fat 566.5 cal) did not significantly affect the total exposure (AUC 0-120h ) and C max of nitisinone following single oral administration of 10 mg nitisinone (5 times the recommended dosage).

The median T max was delayed to 6 hours under fed conditions [see Dosage and Administration ( 2 )] . Distribution The arithmetic mean (SD) apparent volume of distribution of nitisinone is 8.2 (1.6) L in healthy subjects (n=23). In vitro binding of nitisinone to human plasma proteins is greater than 95% at 50 micromolar concentration.

Elimination The arithmetic mean (SD) terminal half-life of nitisinone is 59.3 (8.9) hours in healthy subjects (n=23). The mean (CV%) apparent plasma clearance in 18 healthy adults following multiple once daily doses of nitisinone 80 mg (40 times the recommended dosage) is 113 (16) mL/hr. The mean of the fraction of dose excreted renally as unchanged nitisinone in the urine (fe(%)) was 3% (n=3) following multiple oral doses of 80 mg (40 times the recommended dosage) daily in healthy subjects.

Metabolism In vitro studies have shown that nitisinone is relatively stable in human liver microsomes with minor metabolism possibly mediated by CYP3A4 enzyme. Excretion The estimated mean (CV%) renal clearance of nitisinone was 0.003 L/h (25%). Drug Interaction Studies Clinical Studies Nitisinone does not inhibit CYP2D6.

Nitisinone is a moderate inhibitor of CYP2C9, and a weak inducer of CYP2E1 (TABLE 2). Nitisinone is an inhibitor of OAT1/3 (TABLE 2). TABLE 2.

Percent Change in AUC 0-inf and Cmax for Co-administered Drugs in the Presence of Nitisinone in 18 Healthy Subjects Co-administered Drug a Dose of Co-administered Drug (Route of Administration) Effect of Nitisinone on the Pharmacokinetics of Co-administered Drug b AUC 0-inf C max CYP2C9 Substrate Tolbutamide c 500 mg (oral) 131%↑ 16%↑ CYP2E1 Substrate Chlorzoxazone 250 mg (oral) 27%↓ 18%↓ OAT1/3 Substrate Furosemide 20 mg (intravenous) 72%↑ 12%↑ ↑= Increased; ↓= Decreased a The interacting drug was administered alone on Day 1 and together with nitisinone on Day 17. b Multiple doses of 80 mg nitisinone (40 times the recommended dosage) were administered daily alone from Day 3 to Day 16. c 16 subjects in Period 2 received nitisinone and tolbutamide while 18 subjects in Period 1 received nitisinone alone.

In Vitro Studies CYP450 Enzymes: Nitisinone does not inhibit CYP1A2, 2C19, or 3A4. Nitisinone does not induce CYP1A2, 2B6 or 3A4/5. Transporter Systems: Nitisinone does not inhibit P-gp, BCRP, OATP1B1, OATP1B3 and OCT2.

🧬 Pharmacodynamics 117 words ▾

12.2Pharmacodynamics In patients with AKU, HGA accumulates in various tissues and urine. In an open-label, single center, randomized, no-treatment controlled trial nitisinone treatment resulted in reduction of urinary HGA concentrations in patients with AKU [see Clinical Studies ( 14 )]. Nitisinone exposure-response relationship and time course of pharmacodynamic response for the effectiveness have not been fully characterized.

Nitisinone inhibits catabolism of the amino acid tyrosine and can result in elevated plasma levels of tyrosine in patients with AKU. Treatment with nitisinone does not require routine dietary restriction in patients with AKU; however, patients who develop keratopathies should be monitored and dietary restriction of tyrosine and phenylalanine should be implemented [see Warnings and Precautions ( 5.1 )].

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES The effectiveness of HARLIKU was evaluated in an open-label, single center, randomized, no-treatment controlled trial in 40 adult patients diagnosed with AKU ( NCT00107783 ). Patients received either HARLIKU at 2 mg orally once daily or no treatment for three years. One patient in the HARLIKU group died after experiencing atrial fibrillation and had discontinued treatment one month prior to death, and 2 patients in the no treatment control group discontinued the study early.

Among the 40 patients enrolled in the trial, 27 (67.5%) were male and 13 (32.5%) were female, ranging in age from 38 to 68 with a mean age of 51.7 years. Thirty-seven (92.5%) patients were White, 2 (5%) were Asian, and 1 (2.5%) was American Indian or Alaska Native. Thirty-nine (97.5%) patients were not Hispanic or Latino and 1 (2.5%) patient was Hispanic or Latino.

HARLIKU was effective at reducing levels of urinary HGA. The HARLIKU group had an average percent reduction from baseline of 88% (95% CI: 79, 97%) after 1 year of treatment, which was sustained through three years of treatment with an average percent reduction from baseline of 91% at year 3 (95% CI: 85, 97%). In contrast, the untreated controls had an average increase of 107% from baseline to year 1 (95% CI: 0, 216%) and 108% from baseline to year 3 (95% CI: 19, 198%).

🧪 Nonclinical Toxicology 98 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of nitisinone was assessed in a 26-week oral (gavage) carcinogenicity study in Tg.rasH2 mice. There were no drug-related neoplastic findings in male or female Tg.rasH2 mice at doses up to 100 mg/kg/day nitisinone (approximately 243 times the maximum recommended human daily dose of 2 mg/day). Nitisinone was not genotoxic in the Ames test and the in vivo mouse liver unscheduled DNA synthesis (UDS) test.

Nitisinone was mutagenic in the mouse lymphoma cell (L5178Y/TK+/-) forward mutation test and in an in vivo mouse bone marrow micronucleus test.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 95 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of nitisinone was assessed in a 26-week oral (gavage) carcinogenicity study in Tg.rasH2 mice. There were no drug-related neoplastic findings in male or female Tg.rasH2 mice at doses up to 100 mg/kg/day nitisinone (approximately 243 times the maximum recommended human daily dose of 2 mg/day). Nitisinone was not genotoxic in the Ames test and the in vivo mouse liver unscheduled DNA synthesis (UDS) test.

Nitisinone was mutagenic in the mouse lymphoma cell (L5178Y/TK+/-) forward mutation test and in an in vivo mouse bone marrow micronucleus test.

📄 Package Label / Principal Display Panel 54 words ▾

Principal Display Panel - 2 mg Carton Label NDC 70709-112-60 HARLIKU TM (nitisinone) tablets 2 mg Rx only 60 tablets Principal Display Panel - Carton Label

Principal Display Panel – 2 mg Bottle Label NDC 70709-112-60 HARLIKU TM (nitisinone) tablets 2 mg Rx only CYCLE PHARMA 60 tablets Principal Display Panel - Bottle Label

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

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

Medicare Part D (outpatient prescription) spending for Harliku — 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 Harliku. 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
$769.5K
Claims incl. refills
16
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$48,092.35
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 HARLIKU (this brand).

Top reported reactions

Liver Transplant32
Hepatocellular Carcinoma22
Amino Acid Level Increased16
Treatment Noncompliance14
Hepatic Cirrhosis12
Hepatic Failure12
Death11

Age at onset

Infant1
Child10
Adolescent2
Adult4
Elderly2

Reporter sex

0 reports

Serious outcomes

Hospitalization34
Death28
Disabling11
Life-threatening6
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 14 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Cycle Pharmaceuticals Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cycle Pharmaceuticals Ltd. 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.
← 70709-0102-10 · Cycle 70709-0121-30 · Cycle →
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.