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ZEPZELCA Lurbinectedin .5 mg/mL Injection, Powder, Lyophilized, For Solution, 8 mL — NDC 68727-0712-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ZEPZELCA Lurbinectedin .5 mg/mL Injection, Powder, Lyophilized, For Solution, 8 mL — NDC 68727-712-01 (Billing 68727-0712-01)

by Jazz Pharmaceuticals, Inc. · 8 mL in 1 VIAL, SINGLE-DOSE

This is a package of 8 mL of ZEPZELCA Lurbinectedin .5 mg/mL Injection, Powder, Lyophilized, For Solution from Jazz Pharmaceuticals, Inc., marketed since Jun 2020 and currently FDA-listed. It is this product's only package size.

NDC 68727-0712-01
🏷️ FDA NDC (as labeled) 68727-712-01 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 68727-712-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
68727 labeler · 712 product · 01 package
Package marketed since
Jun 15, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6872771201 0
Medicaid fills, this package
1,194 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68727-712-01
Product NDC 68727-712
11-digit billing NDC 68727071201
NCPDP billing unit EA — each (per item)
RxCUI 2374733, 2374738
UNII 2CN60TN6ZS
Application # NDA213702
SPL Set ID 632bb50c-3bcb-4c85-9056-fc33410550ae
Established class (EPC) Alkylating Drug
Mechanism of action Alkylating Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-06-15
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance LURBINECTEDIN

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

GPI-14 21100024002120
GPI class Zepzelca
GCN Seq No 081197
GCN 48241
HICL code 046626
Ingredient (HICL) Lurbinectedin
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1A
Therapeutic class — specific (HIC3) Antineoplastic - Alkylating Agents
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name ZEPZELCA 4 MG VIAL
FDB brand name Zepzelca
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 081197
  • GCN: 48241
  • GPI-14 (Medi-Span): 21100024002120
  • HICL (First Databank): 046626
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 2374733
Why two NDCs? The FDA registers this code as 68727-712-01 — 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 → 68727-0712-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Alkylating Drug class.

Pharmacologic class Alkylating Drug
Drug family (ATC) Other antineoplastic agents
How it works Alkylating Activity
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 ZEPZELCA 4 MG VIAL Ingredient Lurbinectedin
📖 What it is MedlinePlus · NLM

Lurbinectedin injection is used to treat certain types of small cell lung cancer (SCLC). Lurbinectedin injection is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in your body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats small cell lung cancer in adults. It can be used with atezolizumab as maintenance treatment of extensive-stage disease, or on its own when the cancer has progressed after...
  • You get it as an IV infusion at a clinic over about an hour, usually every 3 weeks. Your team may use a central line to protect your veins and will give anti-nausea medicine first.
  • Tiredness, nausea, vomiting, poor appetite, constipation or diarrhea, and muscle aches are common. Blood counts often drop too, which is why you will have regular blood tests.
  • Call right away for fever, chills or signs of infection, unusual bleeding or bruising, severe muscle pain or weakness, or pain, redness or swelling where the IV is placed. Low bloo...
📖 Read our full Lurbinectedin Injection guide →
1
Nutrient depletion considerations

Lurbinectedin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Lurbinectedin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 $7,019.96 $56,159.71 / 8 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9223 $215.950 / J9223 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)68727-712-01
11-digit billing NDC68727-0712-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9223
DescriptorInjection, lurbinectedin, 0.1 mg
Billing units / pkg40 units
How the units are derivedThis package is 1; the HCPCS unit is 0.1 MG, so one package = 40 billing units.
Medicare Part B spend (2026 (Q1))$31,071,854 · 2,021 claims · $15,374.49 per claim (all NDCs under J9223)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68727-0712-01 You're viewing this Main listing 8 mL in 1 VIAL, SINGLE-DOSE 2020-06-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zepzelca .5 mg/mLthis 68727-0712-01 Jazz 8 ml — — 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

🏛️
2020
First FDA approval
Jun 2020
📍
2026
Currently FDA-listed
6 years listed
🛡️
2040
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

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

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through May 2040. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jun 15, 2020 RLD RS ⏳ ~13.7 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 12324806 — method of use (U-4212)
US 12433890 — method of use (U-4305)
US 7763615 — drug substance (U-4299)
US 12440490 — method of use (U-4252)
US 7763615 — drug substance (U-2836)
Exclusivity I-977
Exclusivity ODE-304
2020 2022 2024 2026 2028 2030 2032 2034 2036 2038 2040
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (5)
PatentTypeUse codeExpires
US 12324806 ↗ Method of use U-4212 May 29, 2040
US 12433890 ↗ Method of use U-4305 May 29, 2040
US 7763615 ↗ Drug substance U-4299 Dec 13, 2029
US 12440490 ↗ Method of use U-4252 May 29, 2040
US 7763615 ↗ Drug substance U-2836 Dec 13, 2029
FDA exclusivity
CodeWhat it grantsExpires
I-977New indication (3-year)Oct 2, 2028
ODE-304Orphan Drug Exclusivity (7-year)Jun 15, 2027
Common questions
Is there a generic version of ZEPZELCA 4 MG VIAL?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for ZEPZELCA 4 MG VIAL. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until May 2040 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

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

Inactive Ingredients / Excipients

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

🧪 Avoiding an ingredient? See Lurbinectedin Injection 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.

  • 2.76 mg / 1 mL UNII 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • .64 mg / 1 mL UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 100 mg / 1 mL UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 1 mL / 1 mL UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 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

LabelerJazz Pharmaceuticals, Inc.
Application holderJAZZ PHARMACEUTICALS IRELAND LTD
FDA applicationNDA213702 (NDA)
Labeler code68727
First marketedJun 2020
Product typeHuman Prescription Drug
Portfolio9 products on file

More NDCs from Jazz Pharmaceuticals, Inc. labeler code 68727

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 📚 References 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE ZEPZELCA is an alkylating drug indicated: • in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, for the maintenance treatment of adult patients with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide. ( 1.1 ) • For the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

( 1.2 ) This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.2 )

1.1Extensive-Stage Small Cell Lung Cancer ZEPZELCA, in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, is indicated for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide.

1.2Metastatic Small Cell Lung Cancer ZEPZELCA is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Recommended Dosage : 3.2 mg/m 2 administered intravenously every 21 days until disease progression or unacceptable toxicity. • Administration via a central venous line is recommended to reduce the risk of extravasation that can cause tissue necrosis requiring debridement ( 5.3 ) • Administer ZEPZELCA as an intravenous infusion over 60 minutes. • To reduce the risk of nausea, administer corticosteroids and serotonin agonists prior to Cycle 1 and consider use for subsequent cycles. ( 2.5 ) • To reduce the risk of febrile neutropenia during treatment with ZEPZELCA in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, administer granulocyte colony-stimulating factor (G-CSF) [Refer to Prescribing Information]. • Moderate Hepatic Impairment : Recommended dosage is 1.6 mg/m 2 administered intravenously every 21 days until disease progression or unacceptable toxicity.

( 2.4 , 8.6 ) • Severe Hepatic Impairment : Avoid use of ZEPZELCA. If use cannot be avoided, the recommended dosage is 1.6 mg/m 2 administered intravenously every 21 days until disease progression or unacceptable toxicity. ( 2.4 , 8.6 )

2.1Recommended Dosage The recommended dosage of ZEPZELCA as a single-agent and as a combination with atezolizumab or atezolizumab and hyaluronidase-tqjs is 3.2 mg/m 2 by intravenous infusion over 60 minutes every 21 days until disease progression or unacceptable toxicity [see Dosage and Administration (2.4) ]. Initiate treatment with ZEPZELCA only if absolute neutrophil count (ANC) is at least 1,500 cells/mm 3 and platelet count is at least 100,000/mm 3 . ZEPZELCA with Intravenous Atezolizumab or atezolizumab and hyaluronidase-tqjs When administering ZEPZELCA on the same day as atezolizumab or atezolizumab and hyaluronidase-tqjs, administer the chosen atezolizumab drug first.

For the recommended dosage of atezolizumab or atezolizumab and hyaluronidase-tqjs refer to the respective Prescribing Information. If discontinuation of atezolizumab or atezolizumab and hyaluronidase-tqjs is required due to an immune-related severe adverse event, treatment with ZEPZELCA may be continued at the same dose as a single agent. If immune toxicity does not resolve or recurs despite discontinuation of atezolizumab, permanently discontinue ZEPZELCA.

2.2Dosage Modifications for Adverse Reactions The recommended dose reductions for adverse reactions are listed in Table 1. Permanently discontinue ZEPZELCA in patients who require a dose interruption of greater than two weeks and in patients who are unable to tolerate 2 mg/m 2 every 21 days. Table 1: Dose Reduction for ZEPZELCA for Adverse Reactions Dose Reduction Total Dose First Second 2.6 mg/m 2 every 21 days 2 mg/m 2 every 21 days Dosage modifications for ZEPZELCA for adverse reactions are presented in Table 2.

Table 2: Dosage Modifications for ZEPZELCA for Adverse Reactions a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. b Patients who have not received primary prophylaxis of G-CSF with isolated Grade 4 neutropenia (neutrophil count less than 500 cells/mm 3 ) may receive G-CSF prophylaxis rather than undergo lurbinectedin dose reduction. Adverse Reaction Severity a Dosage Modification Neutropenia b [see Warnings and Precautions (5.1) ] Grade 4 or Any grade febrile neutropenia • Withhold ZEPZELCA until absolute neutrophil count (ANC) is ≥ 1500/mm 3 • Resume ZEPZELCA at a reduced dose Thrombocytopenia [see Warnings and Precautions (5.1) ] Grade 3 with bleeding or Grade 4 • Withhold ZEPZELCA until platelet ≥ 100,000/mm 3 • Resume ZEPZELCA at reduced dose Hepatotoxicity [see Warnings and Precautions (5.2) ] Grade 2 • Withhold ZEPZELCA until Grade ≤ 1 • Resume ZEPZELCA at same dose Grade ≥ 3 • Withhold ZEPZELCA until Grade ≤ 1 • Resume ZEPZELCA at reduced dose or permanently discontinue Rhabdomyolysis [see Warnings and Precautions (5.4) ] Grade 2 • Withhold ZEPZELCA until Grade ≤ 1 • Resume ZEPZELCA at same dose… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 43 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: 4 mg of lurbinectedin as a sterile, preservative-free, white to off-white lyophilized powder in a single-dose vial for reconstitution prior to intravenous infusion. For injection: 4 mg lyophilized powder in a single-dose vial. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Myelosuppression : Monitor blood counts prior to each administration. Initiate treatment with ZEPZELCA only if baseline neutrophil count is ≥ 1,500 cells/mm 3 and platelet count is ≥ 100,000/mm 3 . For neutrophil count less than 500 cells/mm 3 or any value less than lower limit of normal, administer G-CSF.

Withhold, reduce the dose, or permanently discontinue ZEPZELCA based on severity. ( 5.1 ) • Hepatotoxicity : Monitor liver function tests prior to initiating ZEPZELCA, periodically during treatment and as clinically indicated. Withhold, reduce the dose, or permanently discontinue ZEPZELCA based on severity.

( 5.2 ) • Extravasation Resulting in Tissue Necrosis : Consider use of a central venous catheter to reduce the risk of extravasation. Monitor patients for signs and symptoms of extravasation during the ZEPZELCA infusion. If extravasation occurs, immediately discontinue the infusion, remove the infusion catheter, and monitor for signs and symptoms of tissue necrosis.

( 5.3 ) • Rhabdomyolysis : Monitor creatine phosphokinase (CPK) prior to initiating ZEPZELCA and periodically during treatment as clinically indicated. Withhold, reduce the dose, or permanently discontinue ZEPZELCA based on severity. ( 5.4 ) • Embryo-Fetal Toxicity : Can cause fetal harm.

Advise females and males of reproductive potential of the potential risk to a fetus and to use an effective method of contraception. ( 5.5 )

5.1Myelosuppression ZEPZELCA can cause severe and fatal myelosuppression including febrile neutropenia and sepsis, thrombocytopenia and anemia. Administer ZEPZELCA only to patients with baseline neutrophil count of at least 1,500 cells/mm 3 and platelet count of at least 100,000/mm 3 . To reduce the risk of febrile neutropenia during treatment with ZEPZELCA in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, administer granulocyte colony-stimulating factor (G-CSF) [refer to Prescribing Information] .

Monitor blood counts including neutrophils, red blood cells and platelets prior to each ZEPZELCA administration. For neutrophil count less than 500 cells/mm 3 or any value less than lower limit of normal, administer G-CSF. Withhold, reduce the dose, or permanently discontinue ZEPZELCA based on severity [see Dosage and Administration (2.2) ] .

ZEPZELCA with Intravenous Atezolizumab In the IMforte study [see Adverse Reactions (6.1) ] , primary prophylaxis of G-CSF was administered to 84% of patients. Based on laboratory values, decreased neutrophils occurred in 36%, including 18% Grade 3 or Grade 4 in patients who received ZEPZELCA in combination with atezolizumab. The median time to onset of Grade 3 and 4 decreased neutrophil cells was 31 days and a median duration of 10 days.

Febrile neutropenia occurred in 1.7%. Sepsis occurred in 1%. There were 7 fatal infections: pneumonia (n=3), sepsis (n=3), and febrile neutropenia (n=1).

Based on laboratory values, decreased platelets occurred in 54%, including 15% Grade 3 or Grade 4 in patients who received ZEPZELCA in combination with atezolizumab. The median time to onset of Grade 3 and 4 decreased platelet cells was 31 days and a median duration of 12 days. Based on laboratory values, decreased hemoglobin occurred in 51%, including 13% Grade 3 or Grade 4 in patients who received ZEPZELCA in combination with atezolizumab.

The median time to onset of Grade 3 and 4 decreased hemoglobin was 64 days and a median duration of 8 days. ZEPZELCA as a Single Agent In clinical studies of 554 patients with advanced solid tumors receiving ZEPZELCA as a single agent [see Adverse Reactions (6.1) ] , Grade 3 or 4 neutropenia occurred in 41% of patients, with a median time to onset of 15 days and a median duration of 7 days. Febrile neutropenia occurred in 7% of patients.

Sepsis occurred in 2% of patients and was fatal in 1% (all cases occurred in patients with solid tumors other than SCLC). Grade 3 or 4 thrombocytopenia occurred in 10%, with a median time to onset… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Myelosuppression [see Warnings and Precautions (5.1) ] • Hepatotoxicity [see Warnings and Precautions (5.2) ] • Extravasation Resulting in Tissue Necrosis [see Warnings and Precautions (5.3) ] • Rhabdomyolysis [see Warnings and Precautions (5.4) ] The most common adverse reactions for ZEPZELCA as a single agent, including laboratory abnormalities, (≥ 20%) are leukopenia, lymphopenia, fatigue, anemia, neutropenia, increased creatinine, increased alanine aminotransferase, increased glucose, thrombocytopenia, nausea, decreased appetite, musculoskeletal pain, decreased albumin, constipation, dyspnea, decreased sodium, increased aspartate aminotransferase, vomiting, cough, decreased magnesium and diarrhea.

( 6.1 ) The most common adverse reactions, for ZEPZELCA in combination with atezolizumab including laboratory abnormalities, (≥ 30%) are: decreased lymphocytes, decreased platelets, decreased hemoglobin, decreased neutrophils, nausea, and fatigue/asthenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Jazz Pharmaceuticals, Inc. at 1-800-520-5568 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety population described in the WARNINGS AND PRECAUTIONS reflects exposure to ZEPZELCA in combination with intravenous atezolizumab in the IMforte study [see Clinical Studies (14.1) ] , in 242 patients with extensive stage small cell lung cancer (ES-SCLC) whose disease had not progressed after initial therapy with atezolizumab, carboplatin, and etoposide.

Patients received ZEPZELCA 3.2 mg/m 2 intravenously (IV) in combination with atezolizumab 1200 mg IV every 21 days until disease progression or unacceptable toxicity. Among 242 patients who received ZEPZELCA in combination with intravenous atezolizumab, 34% were exposed for 6 months or longer and 8% were exposed for greater than one year. The most common adverse reactions (≥ 30%), including laboratory abnormalities, in patients who received ZEPZELCA with atezolizumab were decreased lymphocytes, decreased platelets, decreased hemoglobin, decreased neutrophils, nausea, and fatigue/asthenia.

The pooled safety population described in the WARNINGS AND PRECAUTIONS also reflects exposure to ZEPZELCA as a single agent at a dose of 3.2 mg/m 2 intravenously every 21 days in 554 patients with advanced solid tumors. Among 554 patients who received ZEPZELCA, including 105 patients with small cell lung cancer (SCLC) in PM1183-B-005-14 (Study B-005), 24% were exposed for 6 months or longer and 5% were exposed for greater than one year. The most common adverse reactions for ZEPZELCA as a single agent, (Study B-005), including laboratory abnormalities, (≥ 20%) are leukopenia, lymphopenia, fatigue, anemia, neutropenia, increased creatinine, increased alanine aminotransferase, increased glucose, thrombocytopenia, nausea, decreased appetite, musculoskeletal pain, decreased albumin, constipation, dyspnea, decreased sodium, increased aspartate aminotransferase, vomiting, cough, decreased magnesium and diarrhea.

Extensive-Stage Small Cell Lung Cancer (IMforte) The safety of ZEPZELCA in combination with intravenous (IV) atezolizumab was evaluated in IMforte [see Clinical Studies (14) ] . Patients received intravenous ZEPZELCA 3.2 mg/m 2 in combination with intravenous atezolizumab 1200 mg on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. Primary prophylaxis of G-CSF was administered to 84% of patients.

Among 242 patients who received ZEPZELCA with atezolizumab, the median duration of exposure to lurbinectedin was 4.1 months, 33% were exposed for 6 months or lo… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 150 words ▾

7 DRUG INTERACTIONS Effect of Other Drugs on ZEPZELCA : Avoid coadministration with strong or a moderate CYP3A inhibitors and strong CYP3A inducers. ( 7.1 )

7.1Effect of Other Drugs on ZEPZELCA Strong and Moderate CYP3A Inhibitors Coadministration of ZEPZELCA with a strong or a moderate CYP3A inhibitor increases lurbinectedin systemic exposure [see Clinical Pharmacology (12.3) ], which may increase the incidence and severity of adverse reactions to ZEPZELCA. Avoid grapefruit and Seville oranges during ZEPZELCA treatment, as these contain strong or moderate inhibitors of CYP3A. Avoid coadministration of ZEPZELCA with strong or moderate CYP3A inhibitors.

If coadministration cannot be avoided, reduce the dose of ZEPZELCA [see Dosage and Administration (2.3) ] . Strong CYP3A Inducers Avoid coadministration of ZEPZELCA with strong CYP3A inducers. Coadministration of ZEPZELCA with a strong CYP3A inducer may decrease lurbinectedin systemic exposure, which may decrease the efficacy of ZEPZELCA [see Clinical Pharmacology (12.3) ].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Lactation : Advise not to breastfeed. ( 8.2 ) • Hepatic Impairment : Avoid use of ZEPZELCA in patients with severe hepatic impairment. In patients with moderate hepatic impairment, reduce the dose of ZEPZELCA. ( 8.6 )

8.1Pregnancy Risk Summary Based on animal data and its mechanism of action [see Clinical Pharmacology (12.1) ] , ZEPZELCA can cause fetal harm when administered to a pregnant woman. There are no available data to inform the risk of ZEPZELCA use in pregnant women. Intravenous administration of a single lurbinectedin dose (approximately 0.2 times the 3.2 mg/m 2 clinical dose) to pregnant rats during the period of organogenesis caused embryolethality (see Data) .

Advise pregnant women of the potential risk to a fetus. The estimated 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 a reproductive toxicity study, administration of a single lurbinectedin dose of 0.6 mg/m 2 (approximately 0.2 times of the human dose of 3.2 mg/m 2 ) to pregnant rats on Gestation Day 10 resulted in 100% post-implantation loss.

8.2Lactation Risk Summary There are no data on the presence of lurbinectedin in human milk or its effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions from ZEPZELCA in breastfed children, advise women not to breastfeed during treatment with ZEPZELCA and for 2 weeks after the last dose.

8.3Females and Males of Reproductive Potential ZEPZELCA can cause embryolethality at doses lower than the human dose of 3.2 mg/m 2 [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating ZEPZELCA. Contraception Females Advise female patients of reproductive potential to use effective contraception during treatment with ZEPZELCA and for 7 months after the last dose.

Males Advise males with a female sexual partner of reproductive potential to use effective contraception during treatment with ZEPZELCA and for 4 months after the last dose.

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

8.5Geriatric Use ZEPZELCA with Intravenous Atezolizumab Of the 242 patients with ES-SCLC treated with ZEPZELCA and atezolizumab in IMforte, 124 (51%) patients were 65 years of age and older, while 29 (12%) patients were 75 years of age and older. No overall differences in effectiveness were observed between older and younger patients. There was no overall difference in the incidence of serious adverse reactions in patients ≥ 65 years of age and patients < 65 years of age (33% vs.

29%, respectively). There was a higher incidence of Grade 3 or 4 adverse reactions in patients ≥ 65 years of age compared to younger patients (45% vs. 31%, respectively).

ZEPZELCA as a Single Agent Of the 105 patients with SCLC administered ZEPZELCA in clinical studies, 37 (35%) patients were 65 years of age and older, while 9 (9%) patients were 75 years of age and older. No overall difference in effectiveness was observed between patients aged 65 and older and younger patients. There was a higher incidence of serious adverse reactions in patients ≥ 65 years of age than in patients < 65 years of age (49% vs.

26%, respectively). The serious adverse reactions most frequently reported in patients ≥ 65 years of age were related to myelosuppression and consisted of febrile neutropenia (11%), neutropenia (11%), thrombocytopenia (8%), and anemia (8%) [see Adverse Reactions (6.1) ] . There was a higher incidence of Grade 3 or 4 adverse reactions in patients ≥ 65 years of age compared to younger patients (76% vs.

50%, respect… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 184 words ▾

8.1Pregnancy Risk Summary Based on animal data and its mechanism of action [see Clinical Pharmacology (12.1) ] , ZEPZELCA can cause fetal harm when administered to a pregnant woman. There are no available data to inform the risk of ZEPZELCA use in pregnant women. Intravenous administration of a single lurbinectedin dose (approximately 0.2 times the 3.2 mg/m 2 clinical dose) to pregnant rats during the period of organogenesis caused embryolethality (see Data) .

Advise pregnant women of the potential risk to a fetus. The estimated 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 a reproductive toxicity study, administration of a single lurbinectedin dose of 0.6 mg/m 2 (approximately 0.2 times of the human dose of 3.2 mg/m 2 ) to pregnant rats on Gestation Day 10 resulted in 100% post-implantation loss.

🧒 Pediatric Use 16 words ▾

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

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use ZEPZELCA with Intravenous Atezolizumab Of the 242 patients with ES-SCLC treated with ZEPZELCA and atezolizumab in IMforte, 124 (51%) patients were 65 years of age and older, while 29 (12%) patients were 75 years of age and older. No overall differences in effectiveness were observed between older and younger patients. There was no overall difference in the incidence of serious adverse reactions in patients ≥ 65 years of age and patients < 65 years of age (33% vs.

29%, respectively). There was a higher incidence of Grade 3 or 4 adverse reactions in patients ≥ 65 years of age compared to younger patients (45% vs. 31%, respectively).

ZEPZELCA as a Single Agent Of the 105 patients with SCLC administered ZEPZELCA in clinical studies, 37 (35%) patients were 65 years of age and older, while 9 (9%) patients were 75 years of age and older. No overall difference in effectiveness was observed between patients aged 65 and older and younger patients. There was a higher incidence of serious adverse reactions in patients ≥ 65 years of age than in patients < 65 years of age (49% vs.

26%, respectively). The serious adverse reactions most frequently reported in patients ≥ 65 years of age were related to myelosuppression and consisted of febrile neutropenia (11%), neutropenia (11%), thrombocytopenia (8%), and anemia (8%) [see Adverse Reactions (6.1) ] . There was a higher incidence of Grade 3 or 4 adverse reactions in patients ≥ 65 years of age compared to younger patients (76% vs.

50%, respectively).

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Lurbinectedin is an alkylating drug that binds guanine residues in the minor groove of DNA, forming adducts and resulting in a bending of the DNA helix towards the major groove. Adduct formation triggers a cascade of events that can affect the subsequent activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in perturbation of the cell cycle and eventual cell death. Lurbinectedin inhibited human monocyte activity in vitro and reduced macrophage infiltration in implanted tumors in mice.

12.2Pharmacodynamics Lurbinectedin exposure-response relationships and the pharmacodynamic time-course for efficacy have not been fully characterized. Increased incidence of Grade 4 neutropenia and Grade ≥ 3 thrombocytopenia were observed with increased lurbinectedin exposure. Cardiac Electrophysiology No large mean increase in QTc (i.e., > 20 ms) was detected at the recommended dose of 3.2 mg/m 2 .

12.3Pharmacokinetics Following the approved recommended dosage, geometric mean (%CV) of plasma C max and AUC 0-inf , were 107 µg/L (79%) and 551 µg•h/L (94%), respectively. No accumulation of lurbinectedin in plasma is observed upon administrations every 3 weeks. Distribution The volume of distribution of lurbinectedin at steady state is 504 L (39%).

Plasma protein binding is approximately 99%, to both albumin and α-1-acid glycoprotein. Elimination The terminal half-life of lurbinectedin is 51 hours. Total plasma clearance of lurbinectedin is 11 L/h (50%).

Metabolism Lurbinectedin is metabolized by CYP3A in vitro. Excretion After a single dose of radiolabeled lurbinectedin, 89% of the radioactivity was recovered in feces (< 0.2% unchanged) and 6% in urine (1% unchanged). Specific Populations No clinically significant differences in the pharmacokinetics of lurbinectedin were identified based on age (18-85 years), sex, body weight (39-154 kg), or mild to moderate renal impairment (CLcr 30 to 89 mL/min).

The effects of severe renal impairment (CLcr < 30 mL/min) on the pharmacokinetics of lurbinectedin have not been studied. Hepatic Impairment No clinically significant differences in the pharmacokinetics of lurbinectedin were identified for patients with mild hepatic impairment (total bilirubin ≤ ULN and AST > ULN or total bilirubin 1 to 1.5 × ULN and any AST) compared to that of patients with normal hepatic function. No clinically significant differences in the pharmacokinetics of lurbinectedin were identified for patients with moderate hepatic impairment (total bilirubin > 1.5 to 3 × ULN and any AST) who received a lurbinectedin dose of 1.6 mg/m 2 compared to that of patients with mild hepatic impairment who received a dose of 3.2 mg/m 2 .

No clinically significant differences in the pharmacokinetics of lurbinectedin were identified for patients with severe hepatic impairment (total bilirubin > 3 × ULN) who received a lurbinectedin dose of 1.6 mg/m 2 compared to that of patients with mild hepatic impairment who received a dose of 3.2 mg/m 2 . Drug Interactions Studies Clinical Studies and Model-Informed Approaches Effects of CYP3A Inhibitors on Lurbinectedin Strong CYP3A inhibitors: Coadministration of itraconazole (200 mg once daily) increased the systemic exposure (AUC) of total lurbinectedin by 2.7-fold and unbound lurbinectedin by 2.4‑fold.

Moderate CYP3A inhibitors: Coadministration of verapamil (80 mg every 8 hours) and erythromycin (500 mg every 6 hours) is predicted to increase lurbinectedin AUC by 2.3-fold and 2.1-fold, respectively. Weak CYP3A inhibitors: Coadministration of fluvoxamine (150 mg every 12 hours) is predicted to increase lurbinectedin AUC by 1.3-fold. Effects of CYP3A Inducers on Lurbinectedin Coadministration of bosentan (a moderate CYP3A inducer) decreased systemic exposure (AUC) of total lurbinectedin by 20% and unbound lurbinectedin by 19%.

These changes are not considered clinically relevant. In Vitro Studies Cytochrome P… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 86 words ▾

12.1Mechanism of Action Lurbinectedin is an alkylating drug that binds guanine residues in the minor groove of DNA, forming adducts and resulting in a bending of the DNA helix towards the major groove. Adduct formation triggers a cascade of events that can affect the subsequent activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in perturbation of the cell cycle and eventual cell death. Lurbinectedin inhibited human monocyte activity in vitro and reduced macrophage infiltration in implanted tumors in mice.

📦 How Supplied / Storage and Handling 65 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ZEPZELCA (lurbinectedin) for injection is supplied as a sterile, preservative-free, white to off-white lyophilized powder in a single-dose clear glass vial. Each carton (NDC 68727-712-01) contains 4 mg in one single-dose vial. Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F). ZEPZELCA is a hazardous drug. Follow applicable special handling and disposal procedures 1 .

📋 Description 121 words ▾

11 DESCRIPTION ZEPZELCA is an alkylating drug. The chemical name of ZEPZELCA (lurbinectedin) is (1’R,6R,6aR,7R,13S,14S,16R)-8,14-dihydroxy-6’,9-dimethoxy-4,10,23-trimethyl-19-oxo-2’,3’,4’,6,7,9’,12,13,14,16-decahydro-6aH-spiro[7,13-azano-6,16-(epithiopropanooxymethano) [1,3]dioxolo[7,8]isoquinolino[3,2-b][3]benzazocine-20,1’-pyrido[3,4-b]indol]-5-yl acetate. The molecular formula is C 41 H 44 N 4 O 10 S.

The molecular weight is 784.87g/mol, and the chemical structure is: ZEPZELCA for injection 4 mg is supplied as a lyophilized powder in a single-dose vial for reconstitution for intravenous use. The ZEPZELCA lyophilized formulation is comprised of 4 mg lurbinectedin, sucrose (800 mg), lactic acid (22.1 mg), and sodium hydroxide (5.1 mg). Before use, the lyophilizate is reconstituted by addition of 8 mL Sterile Water for Injection USP, yielding a solution containing 0.5 mg/mL lurbinectedin (the calculated concentration is 0.47 mg/mL based on the final volume of 8.5 mL). chemical structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Myelosuppression Advise patients that ZEPZELCA can cause myelosuppression. Inform patients about the signs and symptoms of myelosuppression and to immediately contact their healthcare provider if signs or symptoms occur [see Warnings and Precautions (5.1) ] .

Hepatotoxicity Advise patients that ZEPZELCA can cause hepatotoxicity and to contact their healthcare provider immediately if signs or symptoms occur [see Warnings and Precautions (5.2) ] . Extravasation Resulting in Tissue Necrosis Advise patients that administration of ZEPZELCA through a central venous catheter is recommended because extravasation of ZEPZELCA can cause skin and soft tissue injury, including necrosis requiring debridement. Advise patients to contact their healthcare provider immediately for signs or symptoms of extravasation.

The time to onset of necrosis after extravasation may vary [see Warnings and Precautions (5.3) ] . Rhabdomyolysis Advise patients that rhabdomyolysis has been reported with the use of ZEPZELCA and to contact their healthcare provider immediately for signs and symptoms of rhabdomyolysis [see Warnings and Precautions (5.4) ] . Embryo-Fetal Toxicity • Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.5) , Use in Specific Populations (8.1) ] . • Advise females of reproductive potential to use effective contraception during treatment with ZEPZELCA and for 7 months after the last dose [see Use in Specific Populations (8.3) ] . • Advise males with female partners of reproductive potential to use effective contraception during treatment with ZEPZELCA and for 4 months after the last dose [see Use in Specific Populations (8.3) ] .

Lactation Advise women not to breastfeed during treatment with ZEPZELCA and for at least 2 weeks after the last dose [see Use in Specific Populations (8.2) ] . Drug Interactions Advise patients to inform their healthcare providers of all concomitant medications, herbal and dietary supplements. Advise patients to avoid grapefruit products and Seville oranges during treatment with ZEPZELCA [see Drug Interactions (7.1) ] .

Distributed by: Jazz Pharmaceuticals, Inc. Palo Alto, CA 94306 Under license from Pharma Mar, S.A. Protected by U.S.

Patent No. 7,763,615

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Following the approved recommended dosage, geometric mean (%CV) of plasma C max and AUC 0-inf , were 107 µg/L (79%) and 551 µg•h/L (94%), respectively. No accumulation of lurbinectedin in plasma is observed upon administrations every 3 weeks. Distribution The volume of distribution of lurbinectedin at steady state is 504 L (39%).

Plasma protein binding is approximately 99%, to both albumin and α-1-acid glycoprotein. Elimination The terminal half-life of lurbinectedin is 51 hours. Total plasma clearance of lurbinectedin is 11 L/h (50%).

Metabolism Lurbinectedin is metabolized by CYP3A in vitro. Excretion After a single dose of radiolabeled lurbinectedin, 89% of the radioactivity was recovered in feces (< 0.2% unchanged) and 6% in urine (1% unchanged). Specific Populations No clinically significant differences in the pharmacokinetics of lurbinectedin were identified based on age (18-85 years), sex, body weight (39-154 kg), or mild to moderate renal impairment (CLcr 30 to 89 mL/min).

The effects of severe renal impairment (CLcr < 30 mL/min) on the pharmacokinetics of lurbinectedin have not been studied. Hepatic Impairment No clinically significant differences in the pharmacokinetics of lurbinectedin were identified for patients with mild hepatic impairment (total bilirubin ≤ ULN and AST > ULN or total bilirubin 1 to 1.5 × ULN and any AST) compared to that of patients with normal hepatic function. No clinically significant differences in the pharmacokinetics of lurbinectedin were identified for patients with moderate hepatic impairment (total bilirubin > 1.5 to 3 × ULN and any AST) who received a lurbinectedin dose of 1.6 mg/m 2 compared to that of patients with mild hepatic impairment who received a dose of 3.2 mg/m 2 .

No clinically significant differences in the pharmacokinetics of lurbinectedin were identified for patients with severe hepatic impairment (total bilirubin > 3 × ULN) who received a lurbinectedin dose of 1.6 mg/m 2 compared to that of patients with mild hepatic impairment who received a dose of 3.2 mg/m 2 . Drug Interactions Studies Clinical Studies and Model-Informed Approaches Effects of CYP3A Inhibitors on Lurbinectedin Strong CYP3A inhibitors: Coadministration of itraconazole (200 mg once daily) increased the systemic exposure (AUC) of total lurbinectedin by 2.7-fold and unbound lurbinectedin by 2.4‑fold.

Moderate CYP3A inhibitors: Coadministration of verapamil (80 mg every 8 hours) and erythromycin (500 mg every 6 hours) is predicted to increase lurbinectedin AUC by 2.3-fold and 2.1-fold, respectively. Weak CYP3A inhibitors: Coadministration of fluvoxamine (150 mg every 12 hours) is predicted to increase lurbinectedin AUC by 1.3-fold. Effects of CYP3A Inducers on Lurbinectedin Coadministration of bosentan (a moderate CYP3A inducer) decreased systemic exposure (AUC) of total lurbinectedin by 20% and unbound lurbinectedin by 19%.

These changes are not considered clinically relevant. In Vitro Studies Cytochrome P450 (CYP) enzymes : Lurbinectedin is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4. Lurbinectedin is not an inducer of CYP1A2 or CYP3A4.

Transporter systems: Lurbinectedin is a substrate of MDR1, but is not a substrate of OATB1P1, OATP1B3, OCT1, or MATE1. Lurbinectedin inhibits MDR1, OATP1B1, OATP1B3, and OCT1 but not BCRP, BSEP, MATE1, OAT1, OAT3, or OCT2.

🧬 Pharmacodynamics 56 words ▾

12.2Pharmacodynamics Lurbinectedin exposure-response relationships and the pharmacodynamic time-course for efficacy have not been fully characterized. Increased incidence of Grade 4 neutropenia and Grade ≥ 3 thrombocytopenia were observed with increased lurbinectedin exposure. Cardiac Electrophysiology No large mean increase in QTc (i.e., > 20 ms) was detected at the recommended dose of 3.2 mg/m 2 .

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Extensive-Stage Small Cell Lung Cancer The efficacy of ZEPZELCA in combination with intravenous (IV) atezolizumab was evaluated in IMforte (NCT05091567), a randomized, multicenter, open-label study in patients with first-line extensive-stage small cell lung cancer (ES-SCLC). Patients were eligible if their disease had not progressed after completion of four cycles of atezolizumab, carboplatin and etoposide (induction treatment) and their Eastern Cooperative Oncology Group (ECOG) performance status was 0 or 1. The trial excluded patients with CNS metastases, history of autoimmune disease, or administration of systemic immunosuppressive medications within 1 week prior to enrollment.

Unless contraindicated, primary prophylaxis with granulocyte colony-stimulating factor (G-CSF) was mandated for patients assigned to the ZEPZELCA with atezolizumab arm. The trial randomized 483 patients who had not experienced disease progression following the completion of 4 cycles of intravenous atezolizumab with carboplatin and etoposide 1:1 to one of the following treatment arms: • ZEPZELCA 3.2 mg/m 2 IV with atezolizumab 1200 mg IV once every 3 weeks until disease progression or unacceptable toxicity, or • Atezolizumab 1200 mg IV once every 3 weeks until disease progression or unacceptable toxicity Randomization was stratified by ECOG performance status prior to randomization (0 vs.

1), lactate dehydrogenase (LDH) (≤ ULN vs. > ULN) prior to randomization, presence of liver metastases prior to initial study enrollment (yes vs. no), and prior receipt of prophylactic cranial irradiation (yes vs. no). The major efficacy outcome measures were overall survival (OS) and progression-free survival (PFS) by Independent Review Facility (IRF) per RECIST v1.1. A total of 483 patients were randomized, including 242 to the ZEPZELCA with atezolizumab arm and 241 to the atezolizumab arm.

The median age was 66 years (range 35 to 85); 63% male; 82% White, 13% Asian, 0.8% were Black or African American; 7% were of Hispanic or Latino ethnicity; and 98% were current or previous smokers. Baseline ECOG performance status was 0 (43%) or 1 (57%). Efficacy results are presented in Table 7 and Figures 1 and 2.

Table 7: Efficacy Results from IMforte 1 Measured from the time of randomization 2 Stratified by ECOG performance status, LDH level, presence of liver metastases and prior receipt of prophylactic cranial irradiation 3 Based on the two-sided stratified log-rank test 4 As determined by IRF 5 per RECIST v1.1 (Response Evaluation Criteria in Solid Tumors v1.1) 6 Compared to the allocated alpha of 0.0313 (two-sided) for this interim OS analysis. 7 Compared to the allocated alpha of 0.001 (two- sided) for this final PFS analysis.

CI=confidence interval ZEPZELCA with Atezolizumab N=242 Atezolizumab N=241 Overall Survival 1 Deaths (%) 113 (47%) 136 (56%) Median, months 13.2 10.6 (95% CI) (11.9, 16.4) (9.5, 12.2) Hazard ratio 2 (95% CI) 0.73 (0.57, 0.95) p-value 3, 6 0.0174 Progression-Free Survival 1,4,5 Number of events (%) 174 (72%) 202 (84%) Median, months 5.4 2.1 (95% CI) (4.2, 5.8) (1.6, 2.7) Hazard ratio 2 (95% CI) 0.54 (0.43, 0.67) p-value 3, 7 < 0.0001 Figure 1: Progression Free survival Curve in IMforte Figure 2: Kaplan-Meier Plot of Overall Survival in IMforte Figure 1 Figure 2

14.2Metastatic Small Cell Lung Cancer PM1183-B-005-14 (Study B-005; NCT02454972) is a multicenter, open-label, multi-cohort trial evaluating ZEPZELCA as a single agent in patients with advanced or metastatic solid tumors. A cohort of patients with small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy received ZEPZELCA 3.2 mg/m 2 by intravenous infusion every 21 days (one cycle). Patients received a median of 4 cycles of ZEPZELCA (range 1 to 24 cycles).

The trial excluded patients with central nervous system (CNS) involvement, grade ≥ 3 dyspnea, daily intermittent oxygen requirement, hepatitis or cirrhosis, and immunocompromis… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 92 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity testing of lurbinectedin has not been performed. Lurbinectedin is genotoxic to mammalian cells in the presence and absence of metabolic activation. Lurbinectedin was not mutagenic in vitro in a bacterial reverse mutation (Ames) assay.

Fertility studies with lurbinectedin were not performed. There were no findings in reproductive organs in general toxicology studies in rats, dogs, or monkeys; however, the highest doses and exposures in these studies were all at levels lower than those at the human dose of 3.2 mg/m 2 .

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 89 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity testing of lurbinectedin has not been performed. Lurbinectedin is genotoxic to mammalian cells in the presence and absence of metabolic activation. Lurbinectedin was not mutagenic in vitro in a bacterial reverse mutation (Ames) assay.

Fertility studies with lurbinectedin were not performed. There were no findings in reproductive organs in general toxicology studies in rats, dogs, or monkeys; however, the highest doses and exposures in these studies were all at levels lower than those at the human dose of 3.2 mg/m 2 .

📚 References 8 words ▾

15 REFERENCES 1. "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

📄 Patient Package Insert ~3 min read ▾

Patient Package Insert PATIENT INFORMATION ZEPZELCA ® (zep zel' kah) (lurbinectedin) for injection What is ZEPZELCA? ZEPZELCA may be used to treat adults with a kind of lung cancer called small cell lung cancer (SCLC): • ZEPZELCA may be used in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs as maintenance treatment when your lung cancer: o is a type called “extensive-stage”, which means it has spread or grown, and o has not progressed after first treatment with atezolizumab or atezolizumab and hyaluronidase-tqjs and the chemotherapy medicines carboplatin and etoposide. • ZEPZELCA may be used when your lung cancer: o has spread to other parts of the body (metastatic), and o you have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working.

It is not known if ZEPZELCA is safe and effective in children. Before receiving ZEPZELCA, tell your healthcare provider about all of your medical conditions, including if you: • have liver or kidney problems. • are pregnant or plan to become pregnant. ZEPZELCA can harm your unborn baby.

Females who are able to become pregnant: o Your healthcare provider should do a pregnancy test before you start treatment with ZEPZELCA. o You should use effective birth control (contraception) during treatment with and for 7 months after your last dose of ZEPZELCA. o Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with ZEPZELCA. Males with female partners who are able to become pregnant should use effective birth control during treatment with and for 4 months after your last dose of ZEPZELCA. • are breastfeeding or plan to breastfeed.

It is not known if ZEPZELCA passes into your breastmilk. Do not breastfeed during treatment with ZEPZELCA and for 2 weeks after your last dose of ZEPZELCA. Talk to your healthcare provider about the best way to feed your baby during treatment with ZEPZELCA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how ZEPZELCA works. Know the medicines you take.

Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How will I receive ZEPZELCA? • ZEPZELCA is given by an intravenous (IV) infusion into a vein over 60 minutes. • ZEPZELCA is usually given every 21 days. • Before each treatment with ZEPZELCA, you may receive medicines to help prevent nausea and vomiting or make it less severe. • Your healthcare provider will decide how long you will continue treatment with ZEPZELCA. • Your healthcare provider may do certain tests during your treatment with ZEPZELCA to check you for side effects, and to see how well you respond to the treatment.

What should I avoid while using ZEPZELCA? • Avoid eating or drinking grapefruit, Seville oranges, or products that contain grapefruit juice and Seville oranges during treatment with ZEPZELCA. What are the possible side effects of ZEPZELCA? ZEPZELCA can cause serious side effects, including: • Low blood cell counts.

Low blood counts including low neutrophil counts (neutropenia) and low platelet counts (thrombocytopenia) are common with ZEPZELCA, and can also be severe. Some people with low white blood cell counts may get fever, or an infection throughout the body (sepsis), that can cause death. Your healthcare provider should do blood tests before you receive each treatment with ZEPZELCA to check your blood cell counts.

Tell your healthcare provider right away if you develop: o fever or any other signs of infection o unusual bruising or bleeding o tiredness o pale colored skin • Liver problems. Increased liver function tests are common with ZEPZELCA and can also be severe. Your healthcare provider should do blood tests to check your liver function before you start and during treatment with ZEPZELCA.

Tell your healthcare provider right away if y… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 54 words ▾

Indications of Usage, Extensive-Stage Small Cell Lung Cancer ( 1.1 ) 10/2025 Dosage and Administration ( 2.1 ) 10/2025 Dosage and Administration ( 2.3 ) 04/2025 Dosage and Administration ( 2.4 ) 04/2025 Dosage and Administration ( 2.5 ) 10/2025 Dosage and Administration ( 2.6 ) 10/2025 Warnings and Precautions ( 5 ) 02/2026

📄 Package Label / Principal Display Panel 71 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Carton: NDC 68727-712-01 ZEPZELCA (lurbinectedin) for injection 4 mg per vial FOR INTRAVENOUS INFUSION ONLY Reconstitute before further dilution. Each single-dose vial contains 4 mg of lurbinectedin as a sterile lyophilized powder Rx Only Single-dose vial Discard unused portion. Caution: Cytotoxic agent carton

Package/Label Display Panel Vial: NDC 68727-712-01 ZEPZELCA (lurbinectedin) for injection 4 mg per vial FOR INTRAVENOUS INFUSION ONLY Single-Dose Vial. Discard unused portion. vial

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.2K
Units reimbursed last 4 qtrs
1.3K
Gross reimbursed last 4 qtrs
$8.79M
Avg / prescription
$7,360.97
Avg / unit
$7,017.44
Latest quarter Q4 2025
179Rx
Fee-for-service vs managed care ⓘ
24% FFS 76% MCO
Fee-for-service · 286 Rx Managed care · 908 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 74 units · 1.3 per 100k residents MN Wisconsin: no data reported WI Michigan: 119 units · 1.2 per 100k residents MI New York: 98 units · 0.5 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 16 units · 0.1 per 100k residents IL Indiana: 83 units · 1.2 per 100k residents IN Ohio: 143 units · 1.2 per 100k residents OH Pennsylvania: 55 units · 0.4 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 15 units · 0.2 per 100k residents MA California: 49 units · 0.1 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 38 units · 1.9 per 100k residents NE Missouri: 23 units · 0.4 per 100k residents MO Kentucky: 66 units · 1.5 per 100k residents KY West Virginia: no data reported WV Virginia: 89 units · 1.0 per 100k residents VA Maryland: no data reported MD Connecticut: 16 units · 0.4 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 29 units · 1.4 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 26 units · 0.4 per 100k residents TN North Carolina: 14 units · 0.1 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 12 units · 0.4 per 100k residents MS Alabama: 93 units · 1.8 per 100k residents AL Georgia: 79 units · 0.7 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 49 units · 0.2 per 100k residents TX Florida: 66 units · 0.3 per 100k residents FL
Units reimbursed · per 100k residents
0.11.9
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Nebraska 1.9 /100k
2 Alabama 1.8 /100k
3 Kentucky 1.5 /100k
4 New Mexico 1.4 /100k
5 Minnesota 1.3 /100k
6 Ohio 1.2 /100k
7 Indiana 1.2 /100k
8 Michigan 1.2 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Zepzelca — 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 Zepzelca. 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
$996.9K
Claims incl. refills
70
Beneficiaries
30
Spend / beneficiary
$33,231.40
Spend / claim
$14,242.03
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 Lurbinectedin — the ingredient across all brands.

Top reported reactions

Death144
Disease Progression103
Neutropenia73
Nausea69
Thrombocytopenia60
Fatigue51
Febrile Neutropenia46

Age at onset

Adult29
Elderly27

Reporter sex

1,100 reports
Male · 58%
Female · 42%
Unknown · 0%

Serious outcomes

Hospitalization402
Life-threatening47
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 249 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 ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Jazz Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Jazz Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J9223 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 68727-0250-01 · Jazz 68727-0745-01 · Jazz →
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.