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Zycubo copper histidinate 2.9 mg Injection, Powder, Lyophilized, For Solution, 1 vial — NDC 42358-0329-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Zycubo copper histidinate 2.9 mg Injection, Powder, Lyophilized, For Solution, 1 vial — NDC 42358-329-01 (Billing 42358-0329-01)

by Sentynl Therapeutics, Inc. · 1 VIAL, GLASS in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS

This is a package of 1 vial of Zycubo copper histidinate 2.9 mg Injection, Powder, Lyophilized, For Solution from Sentynl Therapeutics, Inc., marketed since Jan 2026 and currently FDA-listed. It is this product's only package size.

NDC 42358-0329-01
🏷️ FDA NDC (as labeled) 42358-329-01 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 Jul 24, 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 42358-329-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
42358 labeler · 329 product · 01 package
Package marketed since
Jan 26, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
1 EA per package
Barcode (UPC)
0342358329014
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 42358-329-01
Product NDC 42358-329
11-digit billing NDC 42358032901
NCPDP billing unit EA — each (per item)
RxCUI 2732219, 2732224
UNII 9078K3MO9U
UPC 0342358329014
Application # NDA211241
SPL Set ID e3aeefc2-f44d-4337-9c2e-3dba44a89e48
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-12
Route SUBCUTANEOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance COPPER HISTIDINATE

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

GPI-14 79900010162110
GCN Seq No 088559
GCN 58698
HICL code 051085
Ingredient (HICL) Copper Histidinate
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C3
Therapeutic class — intermediate (HIC2) Minerals
HIC3 code C3M
Therapeutic class — specific (HIC3) Mineral Replacement, Miscellaneous
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name ZYCUBO 2.9 MG VIAL
FDB brand name Zycubo
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 088559
  • GCN: 58698
  • GPI-14 (Medi-Span): 79900010162110
  • HICL (First Databank): 051085
  • AHFS class code: 40:12.00.00
  • RxCUI (RxNorm): 2732219
Why two NDCs? The FDA registers this code as 42358-329-01 — 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 → 42358-0329-01. 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.

Clinical

Label name ZYCUBO 2.9 MG VIAL Ingredient Copper Histidinate
📖 What it is MedlinePlus · NLM

Copper histidinate injection is used for the treatment of Menkes disease (an inherited disease in which the body has a problem processing copper in the body). Copper histidinate is in a class of medications called copper replacement agents. It works by providing copper throughout the body.

Read the full MedlinePlus article ↗

Supplement & herbal interactions

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

Pricing

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

Price systemPer mLPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
42358-0329-01 You're viewing this Main listing 1 VIAL, GLASS in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS 2026-01-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zycubo 2.9 mgthis 42358-0329-01 Sentynl 1 vial — — 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

🏛️
2026
First FDA approval
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🛡️
2033
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 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jan 12, 2026 RLD RS ⏳ ~6.3 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
Exclusivity NCE
Exclusivity ODE-520
2026 2028 2030 2032
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.

FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Jan 12, 2031
ODE-520Orphan Drug Exclusivity (7-year)Jan 12, 2033
Common questions
Is there a generic version of ZYCUBO 2.9 MG VIAL?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for ZYCUBO 2.9 MG VIAL. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jan 2033 — 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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

LabelerSentynl Therapeutics, Inc.
Application holderSENTYNL THERAPEUTICS INC
FDA applicationNDA211241 (NDA)
Labeler code42358
First marketedJan 2026
Product typeHuman Prescription Drug
Portfolio4 products on file

More NDCs from Sentynl Therapeutics, Inc. labeler code 42358

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

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 66 words ▾

1 INDICATIONS AND USAGE ZYCUBO is indicated for the treatment of Menkes disease in pediatric patients. ZYCUBO is a copper replacement product indicated for the treatment of Menkes disease in pediatric patients. ( 1 ) Limitations of Use ZYCUBO is not indicated for the treatment of Occipital Horn Syndrome. ( 1 ) Limitations of Use ZYCUBO is not indicated for the treatment of Occipital Horn Syndrome.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Before initiating ZYCUBO, obtain baseline serum copper and ceruloplasmin levels, serum electrolytes, kidney and liver function, and complete blood count. ( 2.1 ) The recommended dosage of ZYCUBO in pediatric patients: Less than 1 year of age is 1.45 mg twice daily (8-12 hours between injections). ( 2.2 ) 1 year of age to less than 17 years of age is 1.45 mg once daily.

( 2.2 ) Monitor serum copper and ceruloplasmin levels, serum electrolytes, kidney and liver function, and complete blood count (CBC). ( 2.3 ) Reconstitute ZYCUBO and administer subcutaneously. ( 2.4 , 2.6 ) See Full Prescribing Information for additional preparation, storage, and administration instructions.

( 2.4 , 2.5 , 2.6 )

2.1Recommended Testing Before Initiating ZYCUBO Before initiating ZYCUBO, obtain baseline serum copper and ceruloplasmin levels, serum electrolytes, kidney and liver function, and complete blood count (CBC) [see Warnings and Precautions ( 5.1 )] .

2.2Recommended Dosage and Administration The recommended dosage of ZYCUBO in pediatric patients: Less than 1 year of age is 1.45 mg administered subcutaneously twice daily (8-12 hours between injections). 1 year of age to less than 17 years of age is 1.45 mg administered subcutaneously once daily.

2.3Dosage and Administration Modifications and Monitoring Monitor serum copper and ceruloplasmin levels, serum electrolytes, kidney and liver function, and complete blood count (CBC) every 6 weeks for the first 6 months, then every 3 months for 18 months, and then every 6 months thereafter during ZYCUBO treatment. If laboratory abnormalities are detected, consider reducing the frequency of ZYCUBO administration or temporarily withholding or permanently discontinuing ZYCUBO. Return to increased frequency of laboratory evaluation when resuming a dosage as clinically indicated [see Warnings and Precautions ( 5.1 )] .

2.4Preparation Instructions Preparation Use aseptic technique during preparation. Reconstitute ZYCUBO using a sterile disposable 3 mL syringe and 1 inch needle (between 16 to 22 gauge) ( see Instructions for Use ). Remove 1 ZYCUBO vial from the refrigerator and set aside for approximately 30 minutes to allow the vial to come to room temperature [20°C to 25°C (68°F to 77°F)] before use.

Reconstitute ZYCUBO by tilting the vial and slowly injecting 1 mL of 0.9% Sodium Chloride Injection, USP down the inside wall of the vial. Gently swirl the vial continuously until the powder is completely dissolved. Do not shake the vial.

Each vial will yield a concentration of 2.9 mg/mL. Visually inspect the reconstituted solution in the vial for particulate matter and discoloration. The solution should be blue.

Discard if particles are present or the solution is discolored (not blue) or cloudy. Do not mix with other medications.

2.5Storage of Reconstituted Solution If the reconstituted ZYCUBO vial is not used immediately, store the vial refrigerated at 2°C to 8°C (36° to 46°F) for up to 24 hours or at controlled room temperature at 20°C to 25°C (68°F to 77°F) for up to 4 hours. Discard the reconstituted ZYCUBO vial if not used within 24 hours of refrigeration or within 4 hours at room temperature.

2.6Administration Instructions A caregiver may administer ZYCUBO to patients after proper training in subcutaneous injection technique if a healthcare provider determines that it is appropriate ( see Instructions for Use ). Administer ZYCUBO using a sterile disposable 1 mL syringe and 1/2 inch injection needle (between 23 to 27 gauge). Slowly withdraw 0.5 mL of reconstituted ZYCUBO solution from the vial and inject subcutaneously.

Administer ZYCUBO by subcutaneous injection at separate sites in the abdominal area (2 inches from the navel), buttocks, and the outer lateral aspect of the upper arm or thigh. Rotate injection sites with each injection to reduce the risk of lipodystrophy. Do not give injections into areas where the skin is scarred, tender, bruised, red, or hard.

Discard u… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 59 words ▾

3 DOSAGE FORMS AND STRENGTHS For Injection: 2.9 mg of copper histidinate (equivalent to 0.5 mg elemental copper) as a blue lyophilized powder or cake in a single-dose vial for reconstitution. For Injection: 2.9 mg of copper histidinate (equivalent to 0.5 mg elemental copper) as a lyophilized powder or cake in a single-dose vial for reconstitution. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Copper Accumulation and Risk of Toxicity : Exogenous administration of copper with ZYCUBO may lead to further copper accumulation and has the potential to result in drug-induced kidney injury, liver dysfunction, and hematological abnormalities. Monitor patients during ZYCUBO treatment. Adjust dosage if necessary. ( 2.2 , 5.1 , 6.1 )

5.1Copper Accumulation and Risk of Toxicity Impaired copper transport in patients with Menkes disease can lead to copper accumulation and organ impairment in the kidneys, liver, and hematopoietic system. Treatment with ZYCUBO may lead to further copper accumulation and related toxicity, especially in the first two years of life given renal and hepatic immaturity. Obtain baseline serum copper and ceruloplasmin levels, serum electrolytes, kidney and liver function, and complete blood count (CBC).

After initiating ZYCUBO, monitor laboratory values every 6 weeks for the first 6 months, then every 3 months for 18 months, and then every 6 months thereafter during ZYCUBO treatment. If laboratory abnormalities are detected, consider reducing the frequency of ZYCUBO administration or temporarily withholding or permanently discontinuing ZYCUBO. Return to increased frequency of laboratory monitoring when resuming a dosage as clinically indicated.

Drug-Induced Kidney Injury Copper accumulation with ZYCUBO use has the potential to result in renal tubular toxicity in patients with Menkes disease. Routinely monitor patients starting or re-starting ZYCUBO for signs and symptoms of renal tubular toxicity. New-onset or worsening non-anion gap metabolic acidosis may be a sign of drug-related renal tubular acidosis.

Increased urinary beta-2 microglobulin and/or new-onset hypophosphatemia, hyponatremia, or hypokalemia may be signs of drug-related proximal renal tubular toxicity. Provide supportive care with electrolyte repletion and supplementation as clinically indicated. Copper accumulation with ZYCUBO use has the potential to result in glomerular injury, leading to decreased kidney function or new-onset proteinuria.

Liver Dysfunction Copper accumulation with ZYCUBO can result in liver dysfunction. Elevations of liver transaminases have been reported in patients taking ZYCUBO for Menkes disease [see Adverse Reactions ( 6.1 )] . Single cell necrosis, inflammation, and fibrosis, along with increased liver transaminases and bilirubin were observed in studies conducted over 13-weeks in juvenile rats with normal baseline copper levels [see Use in Specific Populations ( 8.4 )].

Hematological Abnormalities Copper accumulation with ZYCUBO can result in spleen and bone marrow dysfunction as well as interference with iron metabolism. Anemia has been reported in patients taking ZYCUBO for Menkes disease [see Adverse Reactions ( 6.1 )] . Increased cellularity and pigmented macrophages in the spleen and increased hematological values were observed in studies conducted over 13-weeks in normal juvenile rats [see Use in Specific Populations ( 8.4 )].

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Copper Accumulation and Risk of Toxicity: Drug-Induced Kidney Injury, Liver Dysfunction, Hematological Abnormalities [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (incidence ≥7%) were pneumonia, viral infection, respiratory failure, seizure, bacterial infection, hemorrhage, hypotension, vomiting, tachycardia, pyrexia, volume depletion, fracture, dyspnea, transaminases elevation, diarrhea, fungal infection, anemia, and local administration reaction.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sentynl Therapeutics, Inc. at 1-888-507-5206 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 pooled safety analysis from 2 open-label, single-arm clinical trials included a total of 129 ZYCUBO-treated patients with an age range from 0 to 48 months. Patients less than 1 year of age received ZYCUBO 1.45 mg twice daily, and patients 1 year of age and older received ZYCUBO 1.45 mg once daily.

The median exposure duration was 24 months (range: 1 to 39 months) [see Clinical Studies ( 14 )] . Serious Adverse Reactions Serious adverse reactions reported in ≥5% of ZYCUBO-treated pediatric patients with Menkes disease were pneumonia, dehydration, seizure, respiratory distress, respiratory syncytial virus infection, cardiopulmonary failure, upper respiratory tract infection, respiratory failure, and vomiting. Common Adverse Reactions Table 1 lists the most common adverse reactions that occurred in ≥7% of patients in the pooled safety analysis during an observation period ranging from 1 to 39 months.

Table 1. Adverse Reactions Occurring in ≥7% Patients with Menkes Disease (Trial 1 and Trial 2) 1 Respiratory failure consists of multiple similar terms including cardiopulmonary failure. 2 Bacterial infection consists of multiple similar terms including renal and urinary tract infection.

Adverse Reactions Menkes Disease (N = 129) N (%) Pneumonia 38 (30) Viral infection 35 (27) Respiratory failure 1 30 (23) Cardiopulmonary failure 11 (9) Seizure 29 (23) Bacterial infection 26 (20) Renal and urinary tract infection 2 12 (9) Hemorrhage 23 (18) Hypotension 20 (16) Vomiting 19 (15) Tachycardia 16 (12) Pyrexia 16 (12) Volume depletion 16 (12) Fracture 16 (12) Dyspnea 16 (12) Transaminases elevation 13 (10) Diarrhea 13 (10) Fungal infection 12 (9) Anemia 11 (9) Local administration reaction 9 (7)

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on ZYCUBO use during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with ZYCUBO. The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defects, loss, 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%-4% and 15%-20%, respectively.

8.2Lactation Risk Summary There are no data on the presence of copper histidinate and its metabolites in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ZYCUBO and any potential adverse effects on the breastfed infant from ZYCUBO or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of ZYCUBO for the treatment of Menkes disease have been established in pediatric patients, and the information on this use is discussed throughout the labeling. Juvenile Animal Toxicity Data Juvenile rats with normal baseline copper levels were administered copper histidinate from postnatal day (PND) 10 (the equivalent of a human newborn) to PND 100 (the equivalent of a human adult) subcutaneously twice daily for 13 weeks at 1, 2, and 5 mg/kg. Histopathological findings were observed in the kidney (tubular necrosis, eosinophilic globules), liver (single cell necrosis, inflammation, fibrosis), and spleen (increased cellularity and pigmented macrophages), in addition to increased liver transaminases (ALT, AST) and bilirubin, and decreased red blood cells, hemoglobin and hematocrit at 5 mg/kg (10-fold the human plasma concentration at the recommended dose of ZYCUBO (based on C max )).

Changes in liver (necrosis, inflammation, ALT, AST) and kidney (eosinophilic globules) were also noted as low as 1 mg/kg (equivalent to human plasma concentration at the recommended dose of ZYCUBO (based on C max )). A no-observed-adverse-effect-level (NOAEL) in juvenile rats could not be determined. Proportional increases in copper and ceruloplasmin levels occurred with increasing dose levels.

8.5Geriatric Use Menkes disease is a disease of pediatric patients. Clinical trials of ZYCUBO did not include patients 65 years of age and older.

🤰 Pregnancy 94 words ▾

8.1Pregnancy Risk Summary There are no available data on ZYCUBO use during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with ZYCUBO. The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defects, loss, 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%-4% and 15%-20%, respectively.

🧒 Pediatric Use 197 words ▾

8.4Pediatric Use The safety and effectiveness of ZYCUBO for the treatment of Menkes disease have been established in pediatric patients, and the information on this use is discussed throughout the labeling. Juvenile Animal Toxicity Data Juvenile rats with normal baseline copper levels were administered copper histidinate from postnatal day (PND) 10 (the equivalent of a human newborn) to PND 100 (the equivalent of a human adult) subcutaneously twice daily for 13 weeks at 1, 2, and 5 mg/kg. Histopathological findings were observed in the kidney (tubular necrosis, eosinophilic globules), liver (single cell necrosis, inflammation, fibrosis), and spleen (increased cellularity and pigmented macrophages), in addition to increased liver transaminases (ALT, AST) and bilirubin, and decreased red blood cells, hemoglobin and hematocrit at 5 mg/kg (10-fold the human plasma concentration at the recommended dose of ZYCUBO (based on C max )).

Changes in liver (necrosis, inflammation, ALT, AST) and kidney (eosinophilic globules) were also noted as low as 1 mg/kg (equivalent to human plasma concentration at the recommended dose of ZYCUBO (based on C max )). A no-observed-adverse-effect-level (NOAEL) in juvenile rats could not be determined. Proportional increases in copper and ceruloplasmin levels occurred with increasing dose levels.

🧓 Geriatric Use 25 words ▾

8.5Geriatric Use Menkes disease is a disease of pediatric patients. Clinical trials of ZYCUBO did not include patients 65 years of age and older.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Menkes disease is an X-linked recessive disorder caused by pathogenic variants in the copper transport ATPase encoded by ATP7A . Patients with Menkes disease have impaired absorption of copper from their diet, impaired transport of copper across the blood-brain barrier, and dysregulation of many copper-dependent enzymes. ZYCUBO is a bioavailable copper replacement therapy that is administered as a subcutaneous injection to bypass the impaired gastrointestinal absorption observed in patients with Menkes disease.

12.2Pharmacodynamics Patients with Menkes disease have low serum concentrations of copper and ceruloplasmin. Treatment with ZYCUBO increases serum copper and ceruloplasmin concentrations in patients with Menkes disease. The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of ZYCUBO have not been fully characterized.

12.3Pharmacokinetics The geometric mean (CV%) maximum serum concentration (C max ) of copper histidinate was 67 (36%) ng/mL, the geometric mean (CV%) area under the concentration-time curve from time 0 to 24 hours (AUC 0-24hr ) was 186 (21%) ng•hr/mL, and the geometric mean (CV%) area under the concentration-time curve from time 0 to infinity (AUC 0-inf ) was 296 (15%) ng•hr/mL following a single subcutaneous dose of 3 mg copper histidinate (approximately twice the approved recommended dose for Menkes disease patients 1 year old or older) in healthy adult subjects.

At the recommended dosage, the mean (SD) serum copper concentration increased from a baseline concentration of 30 (25) mcg/dL to 114 (38) mcg/dL at 12 months, and gradually decreased over the 36-month treatment period, with a mean (SD) serum copper concentration of 63 (31) mcg/dL at 36 months. The mean (SD) serum ceruloplasmin concentration was 12 (12) mg/dL at baseline, 33 (11) mg/dL at 12 months, and 20 (8) mg/dL at 36 months [see Clinical Studies ( 14 )] . Absorption The absolute bioavailability of copper histidinate following subcutaneous injection has not been determined.

The median time to reach maximum serum concentrations of copper histidinate (T max ) was 0.75 hours following a single subcutaneous dose of 3 mg copper histidinate (approximately twice the approved recommended dose for Menkes disease patients 1 year old or older) in healthy adult subjects. Distribution The mean (SD) apparent volume of distribution (Vz/F) of copper histidinate during the terminal elimination phase was 1034 (588) L following a single subcutaneous dose of 3 mg copper histidinate (approximately twice the approved recommended dose for Menkes disease patients 1 year old or older) in healthy adult subjects.

Serum copper histidinate concentration-time profiles exhibited an initial decrease followed by a terminal elimination phase, consistent with the release of copper from the copper histidinate complex to the carrier proteins ceruloplasmin and albumin, followed by incorporation of copper histidinate and histidine into the endogenous pools of copper histidinate and histidine, respectively. No binding of copper histidinate to human plasma proteins in vitro has been observed. Elimination The mean (SD) serum clearance (CL/F) of copper histidinate was 10.3 (1.6) L/hr, and the mean terminal half-life was 75 hours following a single subcutaneous dose of 3 mg copper histidinate (approximately twice the approved recommended dose for Menkes disease patients 1 year old or older) in healthy adult subjects.

Metabolism The metabolism of copper histidinate has not been well characterized. Excretion Elimination of elemental copper is through biliary excretion. Drug Interaction Studies In vitro Studies: Copper histidinate is a weak inhibitor of CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP2D6 (IC 50 >100 μM).

Copper histidinate is not an inducer of CYP1A2, CYP2B6, or CYP3A. Transporter Systems: Copper histidinate is not a substrate of BCRP, P-gp, MATE1, MATE2-K, OAT1, OAT3, OAT… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 76 words ▾

12.1Mechanism of Action Menkes disease is an X-linked recessive disorder caused by pathogenic variants in the copper transport ATPase encoded by ATP7A . Patients with Menkes disease have impaired absorption of copper from their diet, impaired transport of copper across the blood-brain barrier, and dysregulation of many copper-dependent enzymes. ZYCUBO is a bioavailable copper replacement therapy that is administered as a subcutaneous injection to bypass the impaired gastrointestinal absorption observed in patients with Menkes disease.

📦 How Supplied / Storage and Handling 92 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ZYCUBO (copper histidinate) for injection is supplied as a sterile, preservative-free, blue lyophilized powder or cake in a single-dose vial. Each vial contains 2.9 mg of copper histidinate (equivalent to 0.5 mg elemental copper). ZYCUBO is available as: One 2.9 mg single-dose vial in a carton: NDC 42358-329-01 Storage and Handling Store ZYCUBO vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton.

Store ZYCUBO reconstituted solution either refrigerated or at controlled room temperature [see Dosage and Administration ( 2.5 )] .

📋 Description 112 words ▾

11 DESCRIPTION ZYCUBO (copper histidinate) for injection is a copper replacement product. The chemical name is copper, (L-histidinato-ϰ N ,ϰ N 3,ϰO)(L-histidinato-ϰ N ,ϰO)-, ( SP -5-14-C)-. The molecular formula is C 12 H 16 CuN 6 O 4 , and the molecular weight is 371.84 g/mol.

Copper histidinate is soluble in water. The chemical structure is: ZYCUBO is a sterile, preservative-free, blue lyophilized powder or cake for subcutaneous injection after reconstitution with 1 mL sterile 0.9% Sodium Chloride Injection, USP. Each single-dose vial contains 2.9 mg of copper histidinate (equivalent to 0.5 mg elemental copper).

The resultant solution has a concentration of 2.9 mg/mL and a pH of 7.4. Chemical Structure

💬 Information for Patients 83 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling ( Instructions for Use ). Drug-Induced Kidney Injury, Liver Dysfunction, and Hematological Abnormalities Advise the patient and/or caregiver of the potential for the patient to experience drug-induced kidney injury, liver dysfunction, and hematological abnormalities. [see Warnings and Precautions ( 5.1 )] . Manufactured by: Zydus Lifesciences Ltd.

Vadodara 391510 India Manufactured for: Sentynl Therapeutics, Inc. Solana Beach, CA 92075 ZYCUBO is a registered trademark of Sentynl Therapeutics, Inc.

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics The geometric mean (CV%) maximum serum concentration (C max ) of copper histidinate was 67 (36%) ng/mL, the geometric mean (CV%) area under the concentration-time curve from time 0 to 24 hours (AUC 0-24hr ) was 186 (21%) ng•hr/mL, and the geometric mean (CV%) area under the concentration-time curve from time 0 to infinity (AUC 0-inf ) was 296 (15%) ng•hr/mL following a single subcutaneous dose of 3 mg copper histidinate (approximately twice the approved recommended dose for Menkes disease patients 1 year old or older) in healthy adult subjects.

At the recommended dosage, the mean (SD) serum copper concentration increased from a baseline concentration of 30 (25) mcg/dL to 114 (38) mcg/dL at 12 months, and gradually decreased over the 36-month treatment period, with a mean (SD) serum copper concentration of 63 (31) mcg/dL at 36 months. The mean (SD) serum ceruloplasmin concentration was 12 (12) mg/dL at baseline, 33 (11) mg/dL at 12 months, and 20 (8) mg/dL at 36 months [see Clinical Studies ( 14 )] . Absorption The absolute bioavailability of copper histidinate following subcutaneous injection has not been determined.

The median time to reach maximum serum concentrations of copper histidinate (T max ) was 0.75 hours following a single subcutaneous dose of 3 mg copper histidinate (approximately twice the approved recommended dose for Menkes disease patients 1 year old or older) in healthy adult subjects. Distribution The mean (SD) apparent volume of distribution (Vz/F) of copper histidinate during the terminal elimination phase was 1034 (588) L following a single subcutaneous dose of 3 mg copper histidinate (approximately twice the approved recommended dose for Menkes disease patients 1 year old or older) in healthy adult subjects.

Serum copper histidinate concentration-time profiles exhibited an initial decrease followed by a terminal elimination phase, consistent with the release of copper from the copper histidinate complex to the carrier proteins ceruloplasmin and albumin, followed by incorporation of copper histidinate and histidine into the endogenous pools of copper histidinate and histidine, respectively. No binding of copper histidinate to human plasma proteins in vitro has been observed. Elimination The mean (SD) serum clearance (CL/F) of copper histidinate was 10.3 (1.6) L/hr, and the mean terminal half-life was 75 hours following a single subcutaneous dose of 3 mg copper histidinate (approximately twice the approved recommended dose for Menkes disease patients 1 year old or older) in healthy adult subjects.

Metabolism The metabolism of copper histidinate has not been well characterized. Excretion Elimination of elemental copper is through biliary excretion. Drug Interaction Studies In vitro Studies: Copper histidinate is a weak inhibitor of CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP2D6 (IC 50 >100 μM).

Copper histidinate is not an inducer of CYP1A2, CYP2B6, or CYP3A. Transporter Systems: Copper histidinate is not a substrate of BCRP, P-gp, MATE1, MATE2-K, OAT1, OAT3, OATP1B1, OAT1B3, or OCT2. Copper histidinate is an inhibitor of BSEP and MATE1.

Copper histidinate is a weak inhibitor of BCRP, MATE2K, OCT1, and OCT2. Copper histidinate is not an inhibitor of P-gp, OAT1, OAT3, OATP1B1, or OATP1B3.

🧬 Pharmacodynamics 49 words ▾

12.2Pharmacodynamics Patients with Menkes disease have low serum concentrations of copper and ceruloplasmin. Treatment with ZYCUBO increases serum copper and ceruloplasmin concentrations in patients with Menkes disease. The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of ZYCUBO have not been fully characterized.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of ZYCUBO was evaluated in pediatric patients with Menkes disease (age at treatment initiation ranges 0.1 to 31.4 months) receiving 3 years of copper histidinate treatment in two open-label, single-arm clinical trials (Trial 1, NCT00001262 and Trial 2, NCT00811785). Data from ZYCUBO-treated patients in these two trials were compared to data from an untreated contemporaneous external control cohort as collected under a protocol amendment of Trial 2. In both trials, pediatric patients: Less than 1 year of age received 1.45 mg of ZYCUBO administered subcutaneously twice daily until 1 year of age.

Equal to or greater than 1 year of age received 1.45 mg of ZYCUBO subcutaneously once daily for up to 3 years. Overall survival was evaluated in a subset of the pooled population from Trial 1 and Trial 2, referred to as the pooled efficacy population. This efficacy population included only patients with Menkes disease who carried a severe pathogenic variant of the ATP7A gene (duplication/deletion, nonsense, or a canonical splice junction variant) and were born after 1999.

There were 83 pediatric patients (66 ZYCUBO; 17 external control) in this pooled efficacy population: 21 patients (21 ZYCUBO) from Trial 1 and 62 patients (45 ZYCUBO; 17 external control) from Trial 2. Patients in the pooled efficacy population were assigned to 1 of 4 cohorts as described in Table 2 . Table 2.

Patient Cohorts in the Pooled Efficacy Population All values are in median (range) 1 Within 4 weeks of birth or within 4 weeks of birth corrected for prematurity (i.e., < 40 weeks' gestation) 2 After 4 weeks of birth or after 4 weeks of birth corrected for prematurity (i.e., < 40 weeks' gestation) Treated Cohorts Untreated Cohorts ZYCUBO- Early Treatment (ZYCUBO-ET) n=31 ZYCUBO- Late Treatment (ZYCUBO-LT) n=35 External Control-Early Treatment (EC-ET) n=17 External Control-Late Treatment (EC-LT) n=16 Eligibility Started ZYCUBO treatment within 4 weeks of birth [1] Started ZYCUBO treatment after 4 weeks of birth [2] No prior ZYCUBO or copper treatment Asymptomatic for significant neurological signs and symptoms approximately 4 weeks after birth Survived at least 4 weeks after diagnosis Subset of the EC-ET cohort Diagnosed with Menkes disease after 4 weeks of birth Survived at least 2 weeks after diagnosis Age at diagnosis (months) 0.1 (-4.5 – 1.9) 4.8 (0.4 – 29.4) 4.7 (2.1 – 22.2) 5.6 (2.1 – 22.2) Age at treatment initiation (months) 0.4 (0.1 – 1.9) 7.1 (1.3 – 31.4) NA NA Treatment duration (months) 34.1 (1.1 – 36) 20 (1.3 – 36) NA NA In the 4 cohorts, 81 patients were male (98%) except for 2 female (2%) patients in ZYCUBO-LT.

The pooled efficacy population included patients with the following race and ethnicity: 52 White (63%), 11 Hispanic (13%), 8 Black or African American (10%), 6 Unknown (7%), 4 Other (5%), and 2 Asian or Pacific Islander (2%). The majority of patients in all 4 cohorts were born prematurely: ZYCUBO-ET = 77%, ZYCUBO-LT = 66%, EC-ET = 82%, and EC-LT = 81%. Efficacy Results Primary Efficacy Results (Overall Survival) in the ZYCUBO-ET and EC-ET Cohorts The primary efficacy analysis compared the overall survival in patients in the ZYCUBO-ET and EC-ET cohorts.

Patients in the ZYCUBO-ET cohort (patients treated with ZYCUBO) had a significant improvement in overall survival compared to patients in the EC-ET cohort, with a 78% reduction in the risk of death ( Table 3 and Figure 1 ). In the ZYCUBO-ET cohort, 15 (48%) patients survived >6 years, including 7 (23%) patients who survived >12 years. In the EC-ET cohort, no patients survived >6 years.

Table 3. Primary Efficacy Results: Overall Survival in ZYCUBO Early Treatment and External Control Early Treatment Cohorts with Menkes Disease CI=Confidence Interval; NE=Not estimable Note: If death dates were unknown, patients were censored at the last known date alive. ZYCUBO-Early Treatment (n=31) External Control-Early Treatment (n=17) Number (%) of Patients Alive 16 (52%) 2 (1… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 83 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Animal studies to evaluate the carcinogenic potential of copper histidinate have not been conducted with ZYCUBO. Mutagenesis ZYCUBO was not mutagenic or clastogenic in a standard battery of genotoxicity tests [bacterial mutagenicity (Ames), micronucleus assay in TK6 cells (in vitro) , and rat bone marrow micronucleus assay (in vivo)] . Impairment of Fertility Animal studies to evaluate effects of copper histidinate on fertility and early embryonic development have not been conducted with ZYCUBO.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 80 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Animal studies to evaluate the carcinogenic potential of copper histidinate have not been conducted with ZYCUBO. Mutagenesis ZYCUBO was not mutagenic or clastogenic in a standard battery of genotoxicity tests [bacterial mutagenicity (Ames), micronucleus assay in TK6 cells (in vitro) , and rat bone marrow micronucleus assay (in vivo)] . Impairment of Fertility Animal studies to evaluate effects of copper histidinate on fertility and early embryonic development have not been conducted with ZYCUBO.

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE ZYCUBO ® [zye kyoo boe] (copper histidinate) for injection, for subcutaneous use This Instructions for Use contains information on how to prepare and inject ZYCUBO. Read this Instructions for Use before you prepare and inject a dose of ZYCUBO for the first time and each time you get a ZYCUBO refill. There may be new information.

This information does not take the place of talking to your healthcare provider about your child's medical condition or their treatment. ZYCUBO is for subcutaneous injection only (inject directly under the skin). Always follow the specific instructions given by your healthcare provider.

If you have questions about preparing or injecting ZYCUBO, call SentynlCares | ZYCUBO Patient Support Services at 1-888-251-2800. Important information you need to know before preparing and injecting ZYCUBO: Your healthcare provider should show you the right way to prepare and inject your child's prescribed dose of ZYCUBO before you do this for the first time. Your healthcare provider will prescribe the amount of ZYCUBO needed for each dose for your child.

Confirm the amount of ZYCUBO needed at each visit with your child's healthcare provider. ZYCUBO comes as a powder or cake in a vial. Each vial of ZYCUBO must be mixed with 0.9% sodium chloride to mix (dissolve) the powder or cake before use.

Do not mix ZYCUBO with anything other than 0.9% sodium chloride. Vials of ZYCUBO are for 1 time use only. Throw the vial away after use, even if there is medicine left in the vial.

Do not save for later use. Throw away used vials in your household trash. If your child misses a dose of ZYCUBO, inject the dose as soon as possible.

Inject the next scheduled dose at least 6 hours after you finish injecting the missed dose. Do not expose ZYCUBO to any heat source, such as a microwave or hot water. Do not share needles and syringes.

See Step 13: “Throw away (dispose of) used needles and syringes.” Storing ZYCUBO and other supplies: Vials of ZYCUBO before mixing : Store ZYCUBO in the refrigerator between 36°F to 46°F (2°C to 8°C). Keep ZYCUBO vials in the original carton until you are ready to use it. Vials of ZYCUBO after mixing : If you do not use the ZYCUBO solution right away after mixing, store the mixed ZYCUBO vial: in the refrigerator between 36°F to 46°F (2°C to 8°C) and use within 24 hours.

Throw away (discard) the mixed ZYCUBO vial if not used within 24 hours. at room temperature between 68°F to 77°F (20°C to 25°C) and use within 4 hours. Throw away (discard) the mixed ZYCUBO vial if not used within 4 hours. Write the date and time you mixed ZYCUBO with 0.9% sodium chloride on the carton.

Do not shake ZYCUBO after it has been mixed. Other supplies: Store other supplies according to the manufacturer instructions (see Step 2: “ Gather and check other supplies ” for a list of supplies needed). Keep ZYCUBO and all medicines out of the reach of children.

Preparing and injecting ZYCUBO Step 1: Gather and check ZYCUBO vial for damage and expiration date a) Remove the ZYCUBO carton from the refrigerator. Remove the ZYCUBO vial from the carton. b) Check the ZYCUBO vial for damage and the expiration date. Do not use the vial and contact the healthcare provider if the vial is damaged, expired or the flip-off cap on the vial is broken or missing. c) Allow the ZYCUBO vial to sit at room temperature for about 30 minutes.

Step 2: Gather and check other supplies 1 vial of 0.9% sodium chloride Check the expiration date on the vial. Do not use the vial if the expiration date has passed. Do not use the vial if the flip-off cap on the vial is broken or missing.

One (1) sterile, 3 mL syringe with 1 inch needle (16 to 22 gauge) for preparing ZYCUBO One (1) sterile, 1 mL syringe with 1/2 inch needle (23 to 27 gauge) for injecting ZYCUBO. Check the expiration dates of both sterile syringes with sterile needles. Do not use if the expiration date has passed.

Do not use if the packaging is damaged. Alcohol wipes Gauze pads or Cotton… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 102 words ▾

Principal Display Panel - 2.9 mg Carton Label NDC 42358-329-01 Zycubo ® (copper histidinate) for injection 2.9 mg/vial For subcutaneous injection One Single-Dose vial Discard unused portion after each single use. Do not administer more than one dose from the vial. Rx only Principal Display Panel - 2.9 mg Carton Label

Principal Display Panel - 2.9 mg Vial Label NDC 42358-329-01 Rx only Zycubo ® (copper histidinate) for injection 2.9 mg/vial For subcutaneous injection One Single-Dose vial Discard unused portion after each single use. Do not administer more than one dose from the vial. Principal Display Panel - 2.9 mg Vial Label

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

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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 Sentynl Therapeutics, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sentynl Therapeutics, 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.
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← 42358-0295-01 · Sentynl 42358-0450-30 · Sentynl →
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