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Irinotecan Hydrochloride 20 mg/mL Injection, Solution — NDC 63323-193-52 (Billing 63323-0193-52)

by Fresenius Kabi USA, LLC · 1 VIAL in 1 BOX / 2 mL in 1 VIAL

This is a package of Irinotecan Hydrochloride 20 mg/mL Injection, Solution from Fresenius Kabi USA, LLC, marketed since Apr 2009 and currently FDA-listed.

NDC 63323-0193-52
🏷️ FDA NDC (as labeled) 63323-193-52 billing pads the product segment with a zero
This package
Contains2 mL in 1 vial Medicaid pays$9.03 / unit · 12 mo Per package$18.07 / 2 ml · Medicaid Pack sizes2 compare ↓
Product page 63323-0193-55 Also comes in: 5 mL 63323-193-55
Rx only Generic 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 →

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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 63323-193-52 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63323 labeler · 193 product · 52 package
Package marketed since
Apr 1, 2009
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0363323193522, 0363323193553
Medicaid fills, this package
100 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) 63323-193-52
Product NDC 63323-193
11-digit billing NDC 63323019352
NCPDP billing unit ML — per mL (volume)
RxCUI 1726319, 1726324
UNII 042LAQ1IIS
UPC 0363323193522, 0363323193553
Application # ANDA077776
SPL Set ID ee45f127-8450-4455-a945-a1f5707f1d39
Established class (EPC) Topoisomerase Inhibitor
Mechanism of action Topoisomerase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-04-01
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance IRINOTECAN HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS

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

GPI-14 21550040102030
GPI class Irinotecan HCl
GCN Seq No 062173
GCN 97955
HICL code 010778
Ingredient (HICL) Irinotecan Hcl
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V3
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs (Continued 1)
HIC3 code V3E
Therapeutic class — specific (HIC3) Antineoplastic - Topoisomerase I Inhibitors
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name IRINOTECAN HCL 40 MG/2 ML VIAL
FDB brand name Irinotecan Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 062173
  • GCN: 97955
  • GPI-14 (Medi-Span): 21550040102030
  • HICL (First Databank): 010778
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 1726319
Why two NDCs? The FDA registers this code as 63323-193-52 — 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 → 63323-0193-52. 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 Topoisomerase Inhibitor class.

Pharmacologic class Topoisomerase Inhibitor
Drug family (ATC) Topoisomerase 1 (TOP1) inhibitors
How it works Topoisomerase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name IRINOTECAN HCL 40 MG/2 ML VIAL Ingredient Irinotecan Hcl
📖 What it is MedlinePlus · NLM

Irinotecan is used alone or in combination with other medications to treat colon or rectal cancer (cancer that begins in the large intestine). Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It works by stopping the growth of cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Irinotecan hydrochloride injection, including Camptosar, treats metastatic colon or rectum cancer. Onivyde, a different product, treats metastatic pancreatic adenocarcinoma in comb...
  • It is given by IV infusion, usually over about 90 minutes, by your care team. The schedule depends on your regimen, so follow what your prescriber sets.
  • Diarrhea is the main side effect to take seriously. Keep loperamide on hand as your team directs and start it at the first loose stool. Call your team promptly, especially if it co...
  • Nausea, vomiting, belly pain, constipation, low appetite, tiredness, fever, low blood counts, and hair loss are common. Call your team for fever or signs of infection, since low wh...
📖 Read our full Irinotecan guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $9.03 $18.07 / 2 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9206 $1.851 / J9206 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)63323-193-52
11-digit billing NDC63323-0193-52
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9206
DescriptorInjection, irinotecan, 20 mg
Billing units / pkg2 units
How the units are derivedThis package is 2; the HCPCS unit is 20 MG, so one package = 2 billing units.
Medicare Part B spend (2026 (Q1))$245,499 · 10,330 claims · $23.77 per claim (all NDCs under J9206)
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
63323-0193-52 You're viewing this 1 VIAL in 1 BOX / 2 mL in 1 VIAL 2009-04-01 — Active
63323-0193-55 63323-193-55 Main listing 1 VIAL in 1 BOX / 5 mL in 1 VIAL 2009-04-01 — Active

This pack accounts for about 21% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 vial in 1 box / 2 ml in 1 vial.
What NDC number is used to bill for this package of Irinotecan Hydrochloride 20 mg/mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Irinotecan Hydrochloride 20 mg/mL 00143-9583-01 Hikma 5 ml — AP FDA listed —
Irinotecan Hydrochloride 20 mg/mL 00143-9701-01 Hikma 5 ml — AP FDA listed —
Irinotecan Hydrochloride 20 mg/mL 00143-9702-01 Hikma 2 ml — AP FDA listed —
Irinotecan hydrochloride 20 mg/mL 16714-0027-01 Northstar 1 vial — AP FDA listed —
Irinotecan hydrochloride 20 mg/mL 16714-0131-01 Northstar 1 vial — AP FDA listed —
Irinotecan Hydrochloride 20 mg/mL 67184-0511-01 Qilu 1 vial — AP FDA listed —
Irinotecan Hydrochloride 20 mg/mL 67184-0512-01 Qilu 1 vial — AP FDA listed —
Irinotecan Hydrochloride 20 mg/mL 67184-0513-01 Qilu 1 vial — AP FDA listed —
Irinotecan hydrochloride 20 mg/mL 68083-0382-01 Gland 1 vial — AP FDA listed —
Irinotecan Hydrochloride 20 mg/mLthis 63323-0193-52 Fresenius 1 vial — AP FDA listed —
Irinotecan hydrochloride 20 mg/mL 45963-0614-85 Actavis 1 vial — AP Discontinued —
Camptosar 20 mg/mL 00009-7529-03 Pharmacia 1 vial — AP Discontinued —
Irinotecan Hydrochloride 20 mg/mL 55150-0353-01 Eugia 1 vial — AP FDA listed —
Irinotecan hydrochloride 20 mg/mL 70700-0170-22 Xiromed 1 vial — AP FDA listed —
Irinotecan Hydrochloride 20 mg/mL 55150-0355-01 Eugia 1 vial — AP FDA listed —
Irinotecan Hydrochloride 20 mg/mL 25021-0230-02 Sagent 1 vial — — FDA listed —
Camptosar 20 mg/mL 00009-0082-02 Pharmacia 1 vial — AP FDA listed —
Irinotecan Hydrochloride 20 mg/mL 55150-0354-01 Eugia 1 vial — AP FDA listed —
Irinotecan Hydrochloride 20 mg/mL 61703-0349-09 Hospira, 1 vial — AP FDA listed —
Camptosar 20 mg/mL 00009-0112-05 Pharmacia 1 vial — AP FDA listed —
Irinotecan Hydrochloride 20 mg/mL 60505-6128-00 Apotex 1 vial — AP FDA listed —
Irinotecan Hydrochloride 20 mg/mL 60505-6272-01 Apotex 1 vial — AP FDA listed —
Irinotecan Hydrochloride 20 mg/mL 55150-0352-01 Eugia 1 vial — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2009
On the market since
Apr 2009
📍
2026
Currently FDA-listed
17 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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

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

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 0.9 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.
  • 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.
  • 45 mg / 1 mL UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in 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

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationANDA077776 (ANDA)
Labeler code63323
First marketedApr 2009
Product typeHuman Prescription Drug
Portfolio554 products on file

More NDCs from Fresenius Kabi USA, LLC labeler code 63323

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

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 197 words ▾

WARNING: DIARRHEA and MYELOSUPPRESSION Early and late forms of diarrhea can occur. Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine. Late diarrhea can be life threatening and should be treated promptly with loperamide.

Monitor patients with diarrhea and give fluid and electrolytes as needed. Institute antibiotic therapy if patients develop ileus, fever, or severe neutropenia. Interrupt irinotecan hydrochloride injection and reduce subsequent doses if severe diarrhea occurs [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 )].

Severe myelosuppression may occur [see Warnings and Precautions ( 5.2 )]. WARNING: DIARRHEA and MYELOSUPPRESSION See full prescribing information for complete boxed warning . Early and late forms of diarrhea can occur.

Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine. Late diarrhea can be life threatening and should be treated promptly with loperamide. Monitor patients with diarrhea and give fluid and electrolytes as needed.

Institute antibiotic therapy if patients develop ileus , fever, or severe neutropenia. Interrupt irinotecan hydrochloride injection and reduce subsequent doses if severe diarrhea occurs. ( 2.2 , 5.1 ) Severe myelosuppression may occur.

( 5.2 )

🎯 Indications and Usage 60 words ▾

1 INDICATIONS AND USAGE Irinotecan hydrochloride injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. Irinotecan hydrochloride injection is a topoisomerase inhibitor indicated for: Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Colorectal cancer single agent regimen 1: Irinotecan hydrochloride injection 125 mg/m 2 intravenous infusion over 90 minutes on days 1, 8, 15, 22 then 2-week rest. ( 2.2 ) Colorectal cancer single agent regimen 2: Irinotecan hydrochloride injection 350 mg/m 2 intravenous infusion over 90 minutes on day 1 every 3 weeks. ( 2.2 )

2.2Colorectal Single Agent Regimens 1 and 2 Administer irinotecan hydrochloride as a 90-minute intravenous infusion. The currently recommended regimens are shown in Table 3 . A reduction in the starting dose by one dose level of irinotecan hydrochloride may be considered for patients with any of the following conditions: prior pelvic/abdominal radiotherapy, performance status of 2, or increased bilirubin levels.

Dosing for patients with bilirubin >2 mg/dL cannot be recommended because there is insufficient information to recommend a dose in these patients. Table 3. Single-Agent Regimens of Irinotecan Hydrochloride Injection and Dose Modifications a Subsequent doses may be adjusted as high as 150 mg/m 2 or to as low as 50 mg/m 2 in 25 to 50 mg/m 2 decrements depending upon individual patient tolerance. b Subsequent doses may be adjusted as low as 200 mg/m 2 in 50 mg/m 2 decrements depending upon individual patient tolerance. c Provided intolerable toxicity does not develop, treatment with additional cycles may be continued indefinitely as long as patients continue to experience clinical benefit.

Regimen 1 (weekly) a 125 mg/m 2 intravenous infusion over 90 minutes, days 1, 8, 15, 22 then 2-week rest Starting Dose and Modified Dose Levels c (mg/m 2 ) Starting Dose Dose Level -1 Dose Level -2 125 100 75 Regimen 2 (every 3 weeks) b 350 mg/m 2 intravenous infusion over 90 minutes, once every 3 weeks c Starting Dose and Modified Dose Levels (mg/m 2 ) Starting Dose Dose Level -1 Dose Level -2 350 300 250 Dose Modifications Based on recommended dose-levels described in Table 3 , Single-Agent Regimens of Irinotecan Hydrochloride and Dose Modifications, subsequent doses should be adjusted as suggested in Table 4 , Recommended Dose Modifications for Single-Agent Schedules.

All dose modifications should be based on the worst preceding toxicity. Table 4. Recommended Dose Modifications For Single-Agent Schedules a a All dose modifications should be based on the worst preceding toxicity b National Cancer Institute Common Toxicity Criteria (version 1.0) c Pretreatment d Excludes alopecia, anorexia, asthenia A new cycle of therapy should not begin until the granulocyte count has recovered to ≥1500/mm 3 , and the platelet count has recovered to ≥100,000/mm 3 , and treatment-related diarrhea is fully resolved.

Treatment should be delayed 1 to 2 weeks to allow for recovery from treatment-related toxicities. If the patient has not recovered after a 2-week delay, consideration should be given to discontinuing irinotecan hydrochloride. Worst Toxicity NCI Grade b (Value) During a Cycle of Therapy At the Start of the Next Cycles of Therapy (After Adequate Recovery), Compared with the Starting Dose in the Previous Cycle a Weekly Weekly Once Every 3 Weeks No toxicity Maintain dose level ↑25 mg/m 2 up to a maximum dose of 150 mg/m 2 Maintain dose level Neutropenia 1 (1500 to 1999/mm 3 ) 2 (1000 to 1499/mm 3 ) 3 (500 to 999/mm 3 ) 4 (<500/mm 3 ) Maintain dose level ↓ 25 mg/m 2 Omit dose until resolved to ≤ grade 2, then ↓ 25 mg/m 2 Omit dose until resolved to ≤ grade 2, then ↓ 50 mg/m 2 Maintain dose level Maintain dose level ↓ 25 mg/m 2 ↓ 50 mg/m 2 Maintain dose level Maintain dose level ↓ 50 mg/m 2 ↓ 50 mg/m 2 Neutropenic fever Omit dose until resolved, then ↓ 50 mg/m 2 when resolved ↓ 50 mg/m 2 ↓ 50 mg/m 2 Other hematologic toxicities Dose modifications for leukopenia, thrombocytopenia, and anemia during a cycle of therapy and at the start of subsequent cycles of therapy are also based on NCI toxicity criteria and are the same as recommended for neutropenia above.

Diarrhea 1 (2-3 stools/day > pretx c )… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 50 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 40 mg/2 mL (20 mg/mL), 100 mg/5 mL (20 mg/mL) sterile, pale yellow, clear, aqueous solution in a single-dose vial. Injection: 40 mg/2 mL (20 mg/mL), 100 mg/5 mL (20 mg/mL) sterile, pale yellow, clear, aqueous solution in a single-dose vial. ( 3 )

⛔ Contraindications 29 words ▾

4 CONTRAINDICATIONS Irinotecan hydrochloride injection is contraindicated in patients with a known hypersensitivity to the drug or its excipients. Hypersensitivity to irinotecan hydrochloride or its excipients ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Diarrhea and Cholinergic Reactions: Early diarrhea (occurring during or shortly after infusion of irinotecan hydrochloride) is usually transient and may be accompanied by cholinergic symptoms. Consider prophylactic or therapeutic administration of 0.25 mg to 1 mg of intravenous or subcutaneous atropine (unless clinically contraindicated). Late diarrhea (generally occurring more than 24 hours after administration of irinotecan hydrochloride) can occur.

Monitor and replace fluid and electrolytes. Treat with loperamide. Use antibiotic support for ileus and fever.

Interrupt irinotecan hydrochloride and reduce subsequent doses if severe diarrhea occurs. ( 5.1 ) Myelosuppression: Manage promptly with antibiotic support. Interrupt irinotecan hydrochloride and reduce subsequent doses if necessary.

( 5.2 ) Increased Risk of Neutropenia in Patients With Reduced UGT1A1 Activity: Individuals with UGT1A1*28/*28, or *6/*6, or *6/*28 genotypes are at increased risk for severe neutropenia during Irinotecan hydrochloride injection treatment. ( 5.3 ) Hypersensitivity: Hypersensitivity reactions including severe anaphylactic or anaphylactoid reactions have been observed. Discontinue irinotecan hydrochloride if this occurs.

( 5.4 ) Renal Impairment/Renal Failure: Rare cases of renal impairment and acute renal failure have been identified, usually in patients who became volume depleted from severe vomiting and/or diarrhea. ( 5.5 ) Pulmonary Toxicity: Interstitial Pulmonary Disease (IPD)-like events, including fatalities, have occurred. Interrupt for new or progressive dyspnea, cough, and fever pending evaluation.

If IPD diagnosed, discontinue and institute appropriate treatment as needed. ( 5.6 ) Toxicity of the 5 Day Regimen: Irinotecan hydrochloride should not be used in combination with a regimen of 5-FU/LV administered for 4-5 consecutive days every 4 weeks outside of a clinical study. ( 5.7 ) Embryo-Fetal Toxicity: Irinotecan hydrochloride can cause fetal harm.

Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. Advise male patients with female partners of reproductive potential to use condoms. ( 5.9 , 8.1 , 8.3 ) Patients With Hepatic Impairment: In clinical trials, irinotecan hydrochloride has not been administered to patients with serum bilirubin > 2.0 mg/dL, or transaminases > 3 times ULN if no liver metastases, or transaminases > 5 times ULN if liver metastases.

With the weekly dosage schedule, patients with total bilirubin levels 1.0-2.0 mg/dL had greater likelihood of grade 3-4 neutropenia. ( 5.10 )

5.1Diarrhea and Cholinergic Reactions Early diarrhea (occurring during or shortly after infusion of irinotecan hydrochloride) is usually transient and infrequently severe. It may be accompanied by cholinergic symptoms of rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, and intestinal hyperperistalsis that can cause abdominal cramping. Bradycardia may also occur.

Early diarrhea and other cholinergic symptoms may be prevented or treated. Consider prophylactic or therapeutic administration of 0.25 mg to 1 mg of intravenous or subcutaneous atropine (unless clinically contraindicated). These symptoms are expected to occur more frequently with higher irinotecan doses.

Late diarrhea (generally occurring more than 24 hours after administration of irinotecan hydrochloride) can be life threatening since it may be prolonged and may lead to dehydration, electrolyte imbalance, or sepsis. Grade 3-4 late diarrhea occurred in 23-31% of patients receiving weekly dosing. In the clinical studies, the median time to the onset of late diarrhea was 5 days with 3-week dosing and 11 days with weekly dosing.

Late diarrhea can be complicated by colitis, ulceration, bleeding, ileus, obstruction, and infection. Cases of megacolon and intestinal perforation have been reported. Patients should have loperamide readily available to begin treatment for late diar… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Common adverse reactions (≥30%) observed in single agent therapy clinical studies are: nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, neutropenia, leukopenia (including lymphocytopenia), anemia, asthenia, fever, body weight decreasing, alopecia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Common adverse reactions (≥30%) observed in single agent therapy clinical studies are: nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, neutropenia, leukopenia (including lymphocytopenia), anemia, asthenia, fever, body weight decreasing, and alopecia.

Second-Line Single-Agent Therapy Weekly Dosage Schedule In three clinical studies evaluating the weekly dosage schedule, 304 patients with metastatic carcinoma of the colon or rectum that had recurred or progressed following 5-FU-based therapy were treated with irinotecan hydrochloride. Seventeen of the patients died within 30 days of the administration of irinotecan hydrochloride; in five cases (1.6%, 5/304), the deaths were potentially drug-related. One of the patients died of neutropenic sepsis without fever.

Neutropenic fever occurred in nine (3.0%) other patients; these patients recovered with supportive care. One hundred nineteen (39.1%) of the 304 patients were hospitalized because of adverse events; 81 (26.6%) patients were hospitalized for events judged to be related to administration of irinotecan hydrochloride injection. The primary reasons for drug-related hospitalization were diarrhea, with or without nausea and/or vomiting (18.4%); neutropenia/leukopenia, with or without diarrhea and/or fever (8.2%); and nausea and/or vomiting (4.9%).

The first dose of at least one cycle of irinotecan hydrochloride was reduced for 67% of patients who began the studies at the 125-mg/m 2 starting dose. Within-cycle dose reductions were required for 32% of the cycles initiated at the 125-mg/m 2 dose level. The most common reasons for dose reduction were late diarrhea, neutropenia, and leukopenia.

Thirteen (4.3%) patients discontinued treatment with irinotecan hydrochloride because of adverse events. The adverse events in Table 7 are based on the experience of the 304 patients enrolled in the three studies described in Clinical Studies ( 14.1). Table 7.

Adverse Events Occurring in >10% of 304 Previously Treated Patients With Metastatic Carcinoma of the Colon or Rectum a a Severity of adverse events based on NCI CTC (version 1.0) b Occurring >24 hours after administration of irinotecan hydrochloride c Occurring ≤24 hours after administration of irinotecan hydrochloride d Primarily upper respiratory infections e Not applicable; complete hair loss = NCI grade 2 Body System & Event % of Patients Reporting NCI Grades 1-4 NCI Grades 3 & 4 GASTROINTESTINAL Diarrhea (late) b 7-9 stools/day (grade 3) ≥ 10 stools/day (grade 4) Nausea Vomiting Anorexia Diarrhea (early) c Constipation 88 86 67 55 51 30 31 (16) (14) 17 12 6 8 2 Flatulence 12 0 Stomatitis 12 1 Dyspepsia 10 0 HEMATOLOGIC Leukopenia Anemia Neutropenia 500 to <1000/mm 3 (grade 3) <500/mm 3 (grade 4) 63 60 54 - - 28 7 26 (15) (12) BODY AS A WHOLE 76 12 Asthenia Abdominal cramping/pain 57 16 Fever 45 1 Pain 24 2 Headache 17 1 Back pain 14 2 Chills 14 0 Minor infection d 14 0 Edema 10 1 Abdominal enlargement 10 0 METABOLIC AND NUTRITIONAL 30 1 ↓ Body weight Dehydration 15 4 ↑ Alkaline phosphatase 13 4 ↑ SGOT 10 1 DERMATOLOGIC 60 NA e Alopecia Sweating 16 0 Rash 13 1 RESPIRATORY 22 4 Dyspnea ↑ Coughing 17 0 Rhinitis 16 0 NEUROLOGIC 19 0 Insomnia Dizziness 15 0 CARDIOVASCULAR Vasodilation (flushing… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Strong CYP3A4 Inducers: Do not administer strong CYP3A4 inducers with irinotecan. ( 7.2 ) Strong CYP3A4 Inhibitors: Do not administer strong CYP3A4 inhibitors with irinotecan. ( 7.3 )

7.2Strong CYP3A4 Inducers Exposure to irinotecan or its active metabolite SN-38 is substantially reduced in adult and pediatric patients concomitantly receiving the CYP3A4 enzyme-inducing anticonvulsants phenytoin, phenobarbital, carbamazepine, or St. John's wort. The appropriate starting dose for patients taking these or other strong inducers such as rifampin and rifabutin has not been defined.

Consider substituting non-enzyme inducing therapies at least 2 weeks prior to initiation of irinotecan therapy. Do not administer strong CYP3A4 inducers with irinotecan unless there are no therapeutic alternatives.

7.3Strong CYP3A4 or UGT1A1 Inhibitors Irinotecan and its active metabolite, SN-38, are metabolized via the human cytochrome P450 3A4 isoenzyme (CYP3A4) and uridine diphosphate- glucuronosyl transferase 1A1 (UGT1A1), respectively, [see Clinical Pharmacology ( 12.3 )] . Patients receiving concomitant ketoconazole, a CYP3A4 and UGT1A1 inhibitor, have increased exposure to irinotecan and its active metabolite SN-38. Coadministration of irinotecan with other inhibitors of CYP3A4 (e.g., clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or UGT1A1 (e.g., atazanavir, gemfibrozil, indinavir) may increase systemic exposure to irinotecan or SN-38.

Discontinue strong CYP3A4 inhibitors at least 1 week prior to starting irinotecan therapy. Do not administer strong CYP3A4 or UGT1A1 inhibitors with irinotecan unless there are no therapeutic alternatives.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 ) Geriatric Use: Closely monitor patients greater than 65 years of age because of a greater risk of early and late diarrhea in this population. ( 8.5 ) Patients With Renal Impairment: Use caution and do not use in patients on dialysis. ( 8.6 ) Patients With Hepatic Impairment: Use caution. (2.1, 5.10 , 8.7 , 12.3 )

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, irinotecan hydrochloride can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . Available postmarketing and published data reporting the use of irinotecan hydrochloride in pregnant women, are insufficient and confounded by the concomitant use of other cytotoxic drugs, to evaluate for any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In animal studies, intravenous administration of irinotecan to rats and rabbits during the period of organogenesis resulted in embryofetal mortality and teratogenicity in pregnant animals at exposures lower than the human exposure based on AUC at the clinical dose of 125 mg/m 2 ( see Data ). Advise pregnant women of the potential risk to a fetus. 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 Radioactivity related to 14 C-irinotecan crosses the placenta of rats following intravenous administration. Intravenous administration of irinotecan to rats at a dose of 6 mg/kg/day (approximately 0.2 times the clinical exposure (AUC) at the 125 mg/m 2 dose based on exposure data from a separate rat study) during the period of organogenesis resulted in increased post-implantation loss and decreased numbers of live fetuses; at doses ≥ 1.2 mg/kg/day (approximately 0.03 times the clinical exposure (AUC) at the 125 mg/m 2 dose based on exposure data from a separate rat study) there were increases in a variety of external, visceral, and skeletal abnormalities.

Administration of irinotecan to pregnant rabbits at a dose of 6 mg/kg (approximately half of the clinical dose of 125 mg/m 2 based on BSA) resulted in similar findings to those in rats, with increased post-implantation loss, decreased live fetuses, and increased external, visceral, and skeletal abnormalities. Irinotecan administered to rat dams for the period following organogenesis through weaning at doses of 6 mg/kg/day caused decreased learning ability and decreased female body weights in the offspring.

8.2Lactation Risk Summary Irinotecan and its metabolites are present in human milk. There is no information regarding the effects of irinotecan on the breastfed infant, or on milk production. Because of the potential for serious adverse reactions from irinotecan hydrochloride in the breastfed child, advise lactating women not to breastfeed during treatment with irinotecan hydrochloride and for 7 days after the final dose.

8.3Females and Males of Reproductive Potential Pregnancy Testing Verify the pregnancy status in female patients of reproductive potential prior to initiating irinotecan hydrochloride. Contraception Irinotecan hydrochloride can cause fetal harm when administered to a pregnant woman. Females Advise female patients of reproductive potential to use effective contraception during treatment and for 6 months after the final dose of irinotecan hydrochloride [see Use in Specific Populations ( 8.1 ) and Nonclinical Toxicology ( 13.1 )] .

Males Due to the potential for genotoxicity, advise male patients with female partners of reproductive potential to use condoms during treatment and for 3 months after the final dose of irinotecan hydrochloride [see Nonclinical Toxicology ( 13.1 )]. Infertility Females Based on postmarketing reports, female fertility may be impaired by treatment with irinotecan hydrochloride. Menstrual dysfunction has… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, irinotecan hydrochloride can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . Available postmarketing and published data reporting the use of irinotecan hydrochloride in pregnant women, are insufficient and confounded by the concomitant use of other cytotoxic drugs, to evaluate for any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In animal studies, intravenous administration of irinotecan to rats and rabbits during the period of organogenesis resulted in embryofetal mortality and teratogenicity in pregnant animals at exposures lower than the human exposure based on AUC at the clinical dose of 125 mg/m 2 ( see Data ). Advise pregnant women of the potential risk to a fetus. 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 Radioactivity related to 14 C-irinotecan crosses the placenta of rats following intravenous administration. Intravenous administration of irinotecan to rats at a dose of 6 mg/kg/day (approximately 0.2 times the clinical exposure (AUC) at the 125 mg/m 2 dose based on exposure data from a separate rat study) during the period of organogenesis resulted in increased post-implantation loss and decreased numbers of live fetuses; at doses ≥ 1.2 mg/kg/day (approximately 0.03 times the clinical exposure (AUC) at the 125 mg/m 2 dose based on exposure data from a separate rat study) there were increases in a variety of external, visceral, and skeletal abnormalities.

Administration of irinotecan to pregnant rabbits at a dose of 6 mg/kg (approximately half of the clinical dose of 125 mg/m 2 based on BSA) resulted in similar findings to those in rats, with increased post-implantation loss, decreased live fetuses, and increased external, visceral, and skeletal abnormalities. Irinotecan administered to rat dams for the period following organogenesis through weaning at doses of 6 mg/kg/day caused decreased learning ability and decreased female body weights in the offspring.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The effectiveness of irinotecan in pediatric patients has not been established. Results from two open-label, single arm studies were evaluated. One hundred and seventy children with refractory solid tumors were enrolled in one phase 2 trial in which 50 mg/m 2 of irinotecan was infused for 5 consecutive days every 3 weeks.

Grade 3-4 neutropenia was experienced by 54 (31.8%) patients. Neutropenia was complicated by fever in 15 (8.8%) patients. Grade 3-4 diarrhea was observed in 35 (20.6%) patients.

This adverse event profile was comparable to that observed in adults. In the second phase 2 trial of 21 children with previously untreated rhabdomyosarcoma, 20 mg/m 2 of irinotecan was infused for 5 consecutive days on weeks 0, 1, 3 and 4. This single agent therapy was followed by multimodal therapy.

Accrual to the single agent irinotecan phase was halted due to the high rate (28.6%) of progressive disease and the early deaths (14%). The adverse event profile was different in this study from that observed in adults; the most significant grade 3 or 4 adverse events were dehydration experienced by 6 patients (28.6%) associated with severe hypokalemia in 5 patients (23.8%) and hyponatremia in 3 patients (14.3%); in addition Grade 3-4 infection was reported in 5 patients (23.8%) (across all courses of therapy and irrespective of causal relationship).

Pharmacokinetic parameters for irinotecan and SN-38 were determined in 2 pediatric solid-tumor trials at dose levels of 50 mg/m 2 (60-min infusion, n=48) and 125 mg/m 2 (90-min infusion, n=6). Irinotecan clearance (mean ± S.D.) was 17.3 ±

6.7L/h/m 2 for the 50 mg/m 2 dose and 16.2 ±

4.6L/h/m 2 for the 125 mg/m 2 dose, which is comparable to that in adults. Dose-normalized SN-38 AUC values were comparable between adults and children. Minimal accumulation of irinotecan and SN-38 was observed in children on daily dosing regimens [daily x 5 every 3 weeks or (daily x 5) x 2 weeks every 3 weeks].

🧓 Geriatric Use 144 words ▾

8.5Geriatric Use Patients greater than 65 years of age should be closely monitored because of a greater risk of early and late diarrhea in this population [see Clinical Pharmacology ( 12.3 ) and Adverse Reactions ( 6.1 )] . The starting dose of irinotecan hydrochloride in patients 70 years and older for the once-every-3-week- dosage schedule should be 300 mg/m 2 [see Clinical Pharmacology ( 12.3 ) and Dosage and Administration ( 2 )] . The frequency of grade 3 and 4 late diarrhea by age was significantly greater in patients ≥65 years than in patients <65 years (40% [53/133] versus 23% [40/171]; p=0.002).

In another study of 183 patients treated on the weekly schedule, the frequency of grade 3 or 4 late diarrhea in patients ≥65 years of age was 28.6% [26/91] and in patients <65 years of age was 23.9% [22/92].

🆘 Overdosage 118 words ▾

10 OVERDOSAGE In U.S. phase 1 trials, single doses of up to 345 mg/m 2 of irinotecan were administered to patients with various cancers. Single doses of up to 750 mg/m 2 of irinotecan have been given in non-U.S. trials. The adverse events in these patients were similar to those reported with the recommended dosage and regimen.

There have been reports of overdosage at doses up to approximately twice the recommended therapeutic dose, which may be fatal. The most significant adverse reactions reported were severe neutropenia and severe diarrhea. There is no known antidote for overdosage of irinotecan hydrochloride injection.

Maximum supportive care should be instituted to prevent dehydration due to diarrhea and to treat any infectious complications.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Irinotecan is a derivative of camptothecin. Camptothecins interact specifically with the enzyme topoisomerase I, which relieves torsional strain in DNA by inducing reversible single-strand breaks. Irinotecan and its active metabolite SN-38 bind to the topoisomerase I-DNA complex and prevent religation of these single-strand breaks.

Current research suggests that the cytotoxicity of irinotecan is due to double-strand DNA damage produced during DNA synthesis when replication enzymes interact with the ternary complex formed by topoisomerase I, DNA, and either irinotecan or SN-38. Mammalian cells cannot efficiently repair these double-strand breaks.

12.2Pharmacodynamics Irinotecan serves as a water-soluble precursor of the lipophilic metabolite SN-38. SN-38 is formed from irinotecan by carboxylesterase-mediated cleavage of the carbamate bond between the camptothecin moiety and the dipiperidino side chain. SN-38 is approximately 1,000 times as potent as irinotecan as an inhibitor of topoisomerase I purified from human and rodent tumor cell lines.

In vitro cytotoxicity assays show that the potency of SN-38 relative to irinotecan varies from 2- to 2,000-fold; however, the plasma area under the concentration versus time curve (AUC) values for SN-38 are 2% to 8% of irinotecan and SN-38 is 95% bound to plasma proteins compared to approximately 50% bound to plasma proteins for irinotecan [see Clinical Pharmacology ( 12.3 )] . The precise contribution of SN-38 to the activity of irinotecan hydrochloride injection is thus unknown. Both irinotecan and SN-38 exist in an active lactone form and an inactive hydroxy acid anion form.

A pH-dependent equilibrium exists between the two forms such that an acid pH promotes the formation of the lactone, while a more basic pH favors the hydroxy acid anion form. Administration of irinotecan has resulted in antitumor activity in mice bearing cancers of rodent origin and in human carcinoma xenografts of various histological types.

12.3Pharmacokinetics After intravenous infusion of irinotecan in humans, irinotecan plasma concentrations decline in a multiexponential manner, with a mean terminal elimination half-life of about 6 to 12 hours. The mean terminal elimination half-life of the active metabolite SN-38 is about 10 to 20 hours. The half-lives of the lactone (active) forms of irinotecan and SN-38 are similar to those of total irinotecan and SN-38, as the lactone and hydroxy acid forms are in equilibrium.

Over the recommended dose range of 50 to 350 mg/m 2 , the AUC of irinotecan increases linearly with dose; the AUC of SN-38 increases less than proportionally with dose. Maximum concentrations of the active metabolite SN-38 are generally seen within 1 hour following the end of a 90 minute infusion of irinotecan. Pharmacokinetic parameters for irinotecan and SN-38 following a 90 minute infusion of irinotecan at dose levels of 125 and 340 mg/m 2 determined in two clinical studies in patients with solid tumors are summarized in Table 9 : Table 9.

Summary of Mean (±Standard Deviation) Irinotecan and SN-38 C max - Maximum plasma concentration AUC 0-24 - Area under the plasma concentration-time curve from time 0 to 24 hours-after the end of the 90-minute infusion t 1/2 - Terminal elimination half-life V z - Volume of distribution of terminal elimination phase CL- Total systemic clearance a Plasma specimens collected for 24 hours following the end of the 90-minute infusion. b Plasma specimens collected for 48 hours following the end of the 90-minute infusion. Because of the longer collection period, these values provide a more accurate reflection of the terminal elimination half-lives of irinotecan and SN-38.

Pharmacokinetic Parameters in Patients With Solid Tumors Dose (mg/m 2 ) Irinotecan SN-38 C max (ng/mL) AUC0-24 (ng·h/mL) t 1/2 (h) V z (L/m 2 ) CL (L/h/m 2 ) C max (ng/mL) AUC 0-24 (ng·h/mL) t 1/2 (h) 125 1,660 10,200 5.8 a 110 13.3 26.3 229 10.4 a (N=64… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 92 words ▾

12.1Mechanism of Action Irinotecan is a derivative of camptothecin. Camptothecins interact specifically with the enzyme topoisomerase I, which relieves torsional strain in DNA by inducing reversible single-strand breaks. Irinotecan and its active metabolite SN-38 bind to the topoisomerase I-DNA complex and prevent religation of these single-strand breaks.

Current research suggests that the cytotoxicity of irinotecan is due to double-strand DNA damage produced during DNA synthesis when replication enzymes interact with the ternary complex formed by topoisomerase I, DNA, and either irinotecan or SN-38. Mammalian cells cannot efficiently repair these double-strand breaks.

📦 How Supplied / Storage and Handling 130 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Each mL of irinotecan hydrochloride injection contains 20 mg irinotecan (on the basis of the trihydrate salt); 45 mg sorbitol; and 0.9 mg lactic acid. Product Code Unit of Sale Strength Each 109352 NDC 63323-193-52 Package of one 40 mg per 2 mL (20 mg per mL) NDC 63323-193-52 2 mL Single-Dose Vial 109355 NDC 63323-193-55 Package of one 100 mg per 5 mL (20 mg per mL) NDC 63323-193-55 5 mL Single-Dose Vial Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light (keep in outer carton).

Inspect the vial for damage and visible signs of leaks before removing from the carton. If damaged, incinerate the unopened package. The container closure is not made with natural rubber latex.

📋 Description 179 words ▾

11 DESCRIPTION Irinotecan hydrochloride injection is an antineoplastic agent of the topoisomerase I inhibitor class. Irinotecan hydrochloride injection is supplied as a sterile, pale yellow, clear, aqueous solution. Each milliliter of solution contains 20 mg of irinotecan hydrochloride (on the basis of the trihydrate salt), 45 mg of sorbitol, NF, and 0.9 mg of lactic acid, USP.

The pH of the solution has been adjusted to 3.5 (range, 3.0 to 3.8) with sodium hydroxide or hydrochloric acid. Irinotecan hydrochloride injection is intended for dilution with 5% Dextrose Injection, USP (D5W), or 0.9% Sodium Chloride Injection, USP, prior to intravenous infusion. The preferred diluent is 5% Dextrose Injection, USP.

Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as Camptotheca acuminata or is chemically synthesized. The chemical name is ( S ) -4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1 H -pyrano[3',4':6,7]-indolizino[1,2-b]quinolin-9-yl-[1,4'bipiperidine]-1'- carboxylate, monohydrochloride, trihydrate. Its empirical formula is C 33 H 38 N 4 O 6 •HCl•3H 2 O and molecular weight is 677.19.

It is slightly soluble in water and organic solvents. Its structural formula is as follows: Structural Formula

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Patients and caregivers should be informed of gastrointestinal complications, such as nausea, vomiting, abdominal cramping, and diarrhea. Patients should have loperamide readily available to begin treatment for late diarrhea (generally occurring more than 24 hours after administration of irinotecan hydrochloride). Begin loperamide at the first episode of poorly formed or loose stools or the earliest onset of bowel movements more frequent than normal.

One dosage regimen for loperamide is 4 mg at the first onset of late diarrhea and then 2 mg every 2 hours until the patient is diarrhea-free for at least 12 hours. Loperamide is not recommended to be used for more than 48 consecutive hours at these doses, because of the risk of paralytic ileus. During the night, the patient may take 4 mg of loperamide every 4 hours.

Patients should contact their physician if any of the following occur: diarrhea for the first time during treatment; black or bloody stools; symptoms of dehydration such as lightheadedness, dizziness, or faintness; inability to take fluids by mouth due to nausea or vomiting; or inability to get diarrhea under control within 24 hours. Patients should be warned about the potential for dizziness or visual disturbances which may occur within 24 hours following the administration of irinotecan hydrochloride. Explain the significance of routine blood cell counts.

Instruct patients to monitor their temperature frequently and immediately report any occurrence of fever or infection. Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.9 ), Use in Specific Populations ( 8.1 , 8.3 ), Clinical Pharmacology ( 12.1 ) and Nonclinical Toxicology ( 13.1 )] Advise pregnant women and females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy. Advise females of reproductive potential to use effective contraception during treatment with irinotecan and for 6 months after the final dose.

Advise male patients with female partners of reproductive potential to use condoms during treatment and for 3 months after the final dose of irinotecan. Lactation Advise women not to breastfeed during treatment with irinotecan and for at least 7 days after the final dose [see Use in Specific Populations ( 8.2 )] . Infertility Advise females and males of reproductive potential that irinotecan may impair fertility [see Use in Specific Populations ( 8.3 )].

Patients should be alerted to the possibility of alopecia. Contains sorbitol. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451321D Fresenius Kabi Logo

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics After intravenous infusion of irinotecan in humans, irinotecan plasma concentrations decline in a multiexponential manner, with a mean terminal elimination half-life of about 6 to 12 hours. The mean terminal elimination half-life of the active metabolite SN-38 is about 10 to 20 hours. The half-lives of the lactone (active) forms of irinotecan and SN-38 are similar to those of total irinotecan and SN-38, as the lactone and hydroxy acid forms are in equilibrium.

Over the recommended dose range of 50 to 350 mg/m 2 , the AUC of irinotecan increases linearly with dose; the AUC of SN-38 increases less than proportionally with dose. Maximum concentrations of the active metabolite SN-38 are generally seen within 1 hour following the end of a 90 minute infusion of irinotecan. Pharmacokinetic parameters for irinotecan and SN-38 following a 90 minute infusion of irinotecan at dose levels of 125 and 340 mg/m 2 determined in two clinical studies in patients with solid tumors are summarized in Table 9 : Table 9.

Summary of Mean (±Standard Deviation) Irinotecan and SN-38 C max - Maximum plasma concentration AUC 0-24 - Area under the plasma concentration-time curve from time 0 to 24 hours-after the end of the 90-minute infusion t 1/2 - Terminal elimination half-life V z - Volume of distribution of terminal elimination phase CL- Total systemic clearance a Plasma specimens collected for 24 hours following the end of the 90-minute infusion. b Plasma specimens collected for 48 hours following the end of the 90-minute infusion. Because of the longer collection period, these values provide a more accurate reflection of the terminal elimination half-lives of irinotecan and SN-38.

Pharmacokinetic Parameters in Patients With Solid Tumors Dose (mg/m 2 ) Irinotecan SN-38 C max (ng/mL) AUC0-24 (ng·h/mL) t 1/2 (h) V z (L/m 2 ) CL (L/h/m 2 ) C max (ng/mL) AUC 0-24 (ng·h/mL) t 1/2 (h) 125 1,660 10,200 5.8 a 110 13.3 26.3 229 10.4 a (N=64) ±797 ±3,270 ±0.7 ±48.5 ±6.01 ±11.9 ±108 ±3.1 340 3,392 20,604 1 l.7 b 234 13.9 56.0 474 21.0 b (N=6) ±874 ±6,027 ±1.0 ±69.6 ±4.0 ±28.2 ±245 ±4.3 Distribution Irinotecan exhibits moderate plasma protein binding (30% to 68% bound). SN-38 is highly bound to human plasma proteins (approximately 95% bound).

The plasma protein to which irinotecan and SN-38 predominantly binds is albumin. Elimination Metabolism Irinotecan is subject to extensive metabolic conversion by various enzyme systems, including esterases that form an active metabolite SN-38, and UGT1A1 which mediates the glucuronidation of SN-38 to form an inactive metabolite. SN-38 glucuronide had 1/50 to 1/100 the activity of SN-38.

Patients who are homozygous for either the UGT1A1*28 or *6 alleles, or who are compound heterozygous for these alleles, have higher SN-38 AUC than patients with the wild-type UGT1A1 alleles [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.3 ), and Clinical Pharmacology ( 12.5 )] . Irinotecan can also undergo CYP3A4-mediated oxidative metabolism to several inactive metabolites, one of which can be hydrolyzed by carboxylesterase to release the active metabolite SN-38. Excretion The disposition of irinotecan has not been fully elucidated in humans.

The urinary excretion of irinotecan is 11% to 20%; SN-38, <1%; and SN-38 glucuronide, 3%. The cumulative biliary and urinary excretion of irinotecan and its metabolites (SN-38 and SN-38 glucuronide) over a period of 48 hours following administration of irinotecan in two patients ranged from approximately 25% (100 mg/m 2 ) to 50% (300 mg/m 2 ). Specific Populations Geriatric Patients The pharmacokinetics of irinotecan administered using the weekly schedule was evaluated in a study of 183 patients that was prospectively designed to investigate the effect of age on irinotecan toxicity.

Results from this trial indicate that there are no differences in the pharmacokinetics of irinotecan, SN- 38, and SN-38 glucuronide in patients <65 years of age compared with pati… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 206 words ▾

12.2Pharmacodynamics Irinotecan serves as a water-soluble precursor of the lipophilic metabolite SN-38. SN-38 is formed from irinotecan by carboxylesterase-mediated cleavage of the carbamate bond between the camptothecin moiety and the dipiperidino side chain. SN-38 is approximately 1,000 times as potent as irinotecan as an inhibitor of topoisomerase I purified from human and rodent tumor cell lines.

In vitro cytotoxicity assays show that the potency of SN-38 relative to irinotecan varies from 2- to 2,000-fold; however, the plasma area under the concentration versus time curve (AUC) values for SN-38 are 2% to 8% of irinotecan and SN-38 is 95% bound to plasma proteins compared to approximately 50% bound to plasma proteins for irinotecan [see Clinical Pharmacology ( 12.3 )] . The precise contribution of SN-38 to the activity of irinotecan hydrochloride injection is thus unknown. Both irinotecan and SN-38 exist in an active lactone form and an inactive hydroxy acid anion form.

A pH-dependent equilibrium exists between the two forms such that an acid pH promotes the formation of the lactone, while a more basic pH favors the hydroxy acid anion form. Administration of irinotecan has resulted in antitumor activity in mice bearing cancers of rodent origin and in human carcinoma xenografts of various histological types.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Irinotecan has been studied in clinical trials as a single agent [see Dosage and Administration ( 2 )]. Weekly and once-every-3-week dosage schedules were used for the single-agent irinotecan studies. Clinical studies of single-agent use are described below.

14.1Metastatic Colorectal Cancer Second-Line Therapy After 5-FU-Based Treatment 4 Weekly Doses on a 6-Week Cycle: Studies 3, 4, and 5 Data from three open-label, single-agent, clinical studies, involving a total of 304 patients in 59 centers, support the use of irinotecan hydrochloride in the treatment of patients with metastatic cancer of the colon or rectum that has recurred or progressed following treatment with 5-FU-based therapy. These studies were designed to evaluate tumor response rate and do not provide information on effects on survival and disease-related symptoms.

In each study, irinotecan hydrochloride was administered in repeated 6-week cycles consisting of a 90-minute intravenous infusion once weekly for 4 weeks, followed by a 2-week rest period. Starting doses of irinotecan hydrochloride in these trials were 100, 125, or 150 mg/m 2 , but the 150-mg/m 2 dose was poorly tolerated (due to high rates of grade 4 late diarrhea and febrile neutropenia). Study 3 enrolled 48 patients and was conducted by a single investigator at several regional hospitals.

Study 4 was a multicenter study conducted by the North Central Cancer Treatment Group. All 90 patients enrolled in Study 4 received a starting dose of 125 mg/m 2 . Study 5 was a multicenter study that enrolled 166 patients from 30 institutions.

The initial dose in Study 5 was 125 mg/m 2 but was reduced to 100 mg/m 2 because the toxicity seen at the 125-mg/m 2 dose was perceived to be greater than that seen in previous studies. All patients in these studies had metastatic colorectal cancer, and the majority had disease that recurred or progressed following a 5-FU-based regimen administered for metastatic disease. The results of the individual studies are shown in Table 11 .

Table 11. Weekly Dosage Schedule: Study Results a Nine patients received 150 mg/m 2 as a starting dose; two (22.2%) responded to Irinotecan. b Relative dose intensity for Irinotecan based on planned dose intensity of 100, 83.3, and 66.7 mg/m 2 /wk corresponding with 150, 125, and 100 mg/m 2 starting doses, respectively. c Confirmed ≥ 4 to 6 weeks after first evidence of objective response. Study 3 4 5 Number of Patients 48 90 64 102 Starting Dose (mg/m 2 /week x 4) 125 a 125 125 100 Demographics and Treatment Administration Study 3 4 5 Number of Patients 48 90 64 102 Starting Dose (mg/m 2 /week x 4) 125 a 125 125 100 Demographics and Treatment Administration Female/Male (%) 46/54 36/64 50/50 51/49 Median Age in years (range) 63 (29-78) 63 (32-81) 61 (42-84) 64 (25-84) Ethnic Origin (%) 79 96 81 91 White African American 12 4 11 5 Hispanic 8 0 8 2 Oriental/Asian 0 0 0 2 Performance Status (%) 60 38 59 44 0 1 38 48 33 51 2 2 14 8 5 Primary Tumor (%) 100 71 89 87 Colon Rectum 0 29 11 8 Unknown 0 0 0 5 Prior 5-FU Therapy (%) 81 66 73 68 For Metastatic Disease ≤ 6 months after Adjuvant 15 7 27 28 > 6 months after Adjuvant 2 16 0 2 Classification Unknown 2 12 0 3 Prior Pelvic/Abdominal Irradiation (%) Yes 3 29 0 0 Other 0 9 2 4 None 97 62 98 96 Duration of Treatment with Irinotecan (median, months) 5 4 4 3 Relative Dose Intensity b (median %) 74 67 73 81 Efficacy Confirmed Objective Response Rate 21 13 14 9 (%) c (95% CI) (9.3 - (6.3 - (5.5 - (3.3 - 14.3) 32.3) 20.4) 22.6) Time to Response (median, months) 2.6 1.5 2.8

2.8Response Duration (median, months) 6.4 5.9 5.6

6.4Survival (median, months) 10.4 8.1 10.7 9.3 1-Year Survival (%) 46 31 45 43 In the intent-to-treat analysis of the pooled data across all three studies, 193 of the 304 patients began therapy at the recommended starting dose of 125 mg/m 2 . Among these 193 patients, 2 complete and 27 partial responses were observed, for an overall response rate of 15.0% (95% Confi… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies with irinotecan were not conducted. Rats were, however, administered intravenous doses of 2 mg/kg or 25 mg/kg irinotecan once per week for 13 weeks (in separate studies, the 25 mg/kg dose produced an irinotecan C max and AUC that were about 7.0 times and 1.3 times the respective values in patients administered 125 mg/m 2 weekly) and were then allowed to recover for 91 weeks. Under these conditions, there was a significant linear trend with dose for the incidence of combined uterine horn endometrial stromal polyps and endometrial stromal sarcomas.

Irinotecan was clastogenic both in vitro (chromosome aberrations in Chinese hamster ovary cells) and in vivo (micronucleus test in mice). Neither irinotecan nor its active metabolite SN-38 was mutagenic in the in vitro Ames assay. No significant adverse effects on fertility and general reproductive performance were observed after intravenous administration of irinotecan in doses of up to 6 mg/kg/day to rats and rabbits; however, atrophy of male reproductive organs was observed after multiple daily irinotecan doses both in rodents at 20 mg/kg and in dogs at 0.4 mg/kg.

In separate studies in rodents, this dose produced an irinotecan C max and AUC about 5 and 1 times, respectively, of the corresponding values in patients administered 125 mg/m 2 weekly. In dogs this dose produced an irinotecan C max and AUC about one-half and 1/15th, respectively, of the corresponding values in patients administered 125 mg/m 2 weekly.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies with irinotecan were not conducted. Rats were, however, administered intravenous doses of 2 mg/kg or 25 mg/kg irinotecan once per week for 13 weeks (in separate studies, the 25 mg/kg dose produced an irinotecan C max and AUC that were about 7.0 times and 1.3 times the respective values in patients administered 125 mg/m 2 weekly) and were then allowed to recover for 91 weeks. Under these conditions, there was a significant linear trend with dose for the incidence of combined uterine horn endometrial stromal polyps and endometrial stromal sarcomas.

Irinotecan was clastogenic both in vitro (chromosome aberrations in Chinese hamster ovary cells) and in vivo (micronucleus test in mice). Neither irinotecan nor its active metabolite SN-38 was mutagenic in the in vitro Ames assay. No significant adverse effects on fertility and general reproductive performance were observed after intravenous administration of irinotecan in doses of up to 6 mg/kg/day to rats and rabbits; however, atrophy of male reproductive organs was observed after multiple daily irinotecan doses both in rodents at 20 mg/kg and in dogs at 0.4 mg/kg.

In separate studies in rodents, this dose produced an irinotecan C max and AUC about 5 and 1 times, respectively, of the corresponding values in patients administered 125 mg/m 2 weekly. In dogs this dose produced an irinotecan C max and AUC about one-half and 1/15th, respectively, of the corresponding values in patients administered 125 mg/m 2 weekly.

📚 References 7 words ▾

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

📄 Recent Major Changes 51 words ▾

Dosage and Administration, Dosage in Patients With Reduced UGT1A1 Activity ( 2.3 ) 1/2022 Dosage and Administration, Preparation of Infusion Solution ( 2.5 ) 1/2022 Dosage and Administration, Safe Handling ( 2.6 ) 1/2022 Warnings and Precautions, Increased Risk of Neutropenia in Patients With Reduced UGT1A1 Activity ( 5.3 ) 1/2022

📄 Package Label / Principal Display Panel 217 words ▾

PACKAGE LABEL - PRINCIPAL DISPLAY - Irinotecan 2 mL Single Dose Vial Label NDC 63323-193-52 109352 Irinotecan Hydrochloride Injection 40 mg per 2 mL (20 mg per mL) On basis of trihydrate. For intravenous use. MUST BE DILUTED. Cytotoxic agent. 2 mL Single Dose Vial Rx only vial

PACKAGE LABEL - PRINCIPAL DISPLAY - Irinotecan 2 mL Single Dose Vial Carton Panel NDC 63323-193-52 109352 Irinotecan Hydrochloride Injection 40 mg per 2 mL (20 mg per mL) On basis of trihydrate. For intravenous use. MUST BE DILUTED. Cytotoxic agent. Rx only 2 mL Single-Dose Vial pbox

PACKAGE LABEL - PRINCIPAL DISPLAY - Irinotecan 5 mL Single Dose Vial Label NDC 63323-193-55 109355 Irinotecan Hydrochloride Injection 100 mg per 5 mL (20 mg per mL) On basis of trihydrate. For intravenous use. MUST BE DILUTED. Cytotoxic agent. 5 mL Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Irinotecan 5 mL Single Dose Vial Label

PACKAGE LABEL – PRINCIPAL DISPLAY - Irinotecan 5 mL Single Dose Vial Carton Panel NDC 63323-193-55 109355 Irinotecan Hydrochloride Injection 100 mg per 5 mL (20 mg per mL) On basis of trihydrate. For intravenous use. MUST BE DILUTED. Cytotoxic agent. Rx only 5 mL Single-Dose Vial PACKAGE LABEL – PRINCIPAL DISPLAY - Irinotecan 5 mL Single Dose Vial Carton Panel

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
100
Units reimbursed last 4 qtrs
1K
Gross reimbursed last 4 qtrs
$9.1K
Avg / prescription
$91.16
Avg / unit
$9.0347
Latest quarter Q4 2025
0Rx
Fee-for-service vs managed care ⓘ
52% FFS 48% MCO
Fee-for-service · 52 Rx Managed care · 48 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 160 units · 5.0 per 100k residents IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 89 units · 0.7 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 760 units · 2.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.75.0
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 Iowa 5.0 /100k
2 California 2.0 /100k
3 Pennsylvania 0.7 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 vial63323-0193-55 379 Rx · $15,013
1 vial this page63323-0193-52 100 Rx · $9,116
Drug total (last 4 qtrs): 479 Rx · 5,620 units · $24,129 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 — Not published for this NDC No photo available yet for this listing.
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 Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (63323-0193-55). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Fresenius Kabi USA, LLC 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 J9206 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.
← 63323-0192-02 · Fresenius 63323-0201-10 · Fresenius →
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.