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Nelarabine Injection

Nelarabine injection is a chemotherapy medicine used to treat T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adults and children aged 1 year and older whose cancer has returned or stopped responding to prior treatment.

Brand name Arranon
Drug class Nucleoside Metabolic Inhibitor
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 15 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 6, 2026 🚨Recall on record
Nelarabine Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Nelarabine (Arranon) is a specialist chemotherapy, available as a generic, reserved for T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma that has returned or stopped responding after at least two earlier treatment regimens; the body converts it into an active form that blocks cancer cells from copying their DNA. It is a demanding treatment, and fatigue, drowsiness and nausea are common, along with low blood counts that raise the risk of infection and bleeding. Its boxed warning is for serious nerve and brain damage, so report new numbness, tingling, weakness, trouble walking, confusion or severe sleepiness right away, because the damage does not always reverse. Expect blood counts and nerve checks throughout treatment.

Clinical pearls

  • Mention past intrathecal chemotherapy (chemo into the spinal fluid) or brain or spine radiation, which raises nerve risk.
  • Avoid live vaccines, and it should never be given with pentostatin or other adenosine deaminase inhibitors.
  • Stay well hydrated around infusions, since it can trigger tumor lysis syndrome (a dangerous chemical surge as cancer cells die).
  • Use effective contraception during treatment; men should use condoms during treatment and for 3 months after the last dose.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Nelarabine carries a boxed warning — the FDA's most serious safety alert — for severe nervous system (neurological) reactions. These can include extreme drowsiness, seizures, muscle weakness, paralysis, and nerve damage affecting the whole body. Some reactions resemble Guillain-Barré syndrome, a serious condition where the immune system attacks the nerves. In some patients, these effects have not fully reversed even after stopping treatment. Your care team must monitor you frequently for these signs. If a neurological reaction of moderate severity or worse develops, nelarabine will be stopped.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asInjection
Earliest FDA record2005
Companies listing it with the FDA14
FDA label last updatedMar 31, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Nelarabine Injection, written from its FDA label.

What Nelarabine Injection is used for

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Nelarabine injection is a chemotherapy medicine approved for two specific blood cancers in patients who have not had success with prior treatments.

  • T-cell acute lymphoblastic leukemia (T-ALL): Arranon is approved to treat this aggressive leukemia in adults and children aged 1 year and older whose disease has returned or didn't respond to at least 2 chemotherapy regimens.
  • T-cell lymphoblastic lymphoma (T-LBL): Arranon is also approved for this closely related lymphoma, under the same patient criteria — relapsed or refractory disease after at least 2 prior treatments.

How Nelarabine Injection works

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Nelarabine is a prodrug, meaning the body must convert it into its active form before it can work. Once infused, an enzyme called adenosine deaminase rapidly transforms it into a compound called ara-G. Ara-G then gets further activated inside leukemia cells, eventually integrating into their DNA. Once embedded in DNA, it blocks the cell from copying itself — halting the cancer's growth and triggering cell death. Leukemia cells (called blasts) are especially vulnerable to this process because they accumulate the active form at high levels.

Nelarabine Injection dosage

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Nelarabine injection is given only by IV infusion by a trained healthcare professional — never self-administered at home. Adults and children follow different schedules within a 21-day treatment cycle.

  • Adults: Infused over 2 hours on Days 1, 3, and 5 of each 21-day cycle.
  • Children (age 1 and older): Infused over 1 hour once daily for 5 consecutive days every 21 days.

Treatment continues until the disease progresses, side effects become unacceptable, the patient qualifies for a stem cell transplant, or it's no longer helping. Always follow your care team's exact schedule; do not adjust doses on your own.

Dosing details from the FDA-approved label

From the Nelarabine Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Adult Dosage
    • 1,500 mg/m2 administered by intravenous infusion over 2 hours on Days 1, 3, and 5 repeated every 21 days
    • Administer undiluted
    • No dose adjustment recommended for CLCr greater than or equal to 50 mL/min; insufficient data to support a dose recommendation for CLCr less than 50 mL/min
  • Pediatric Dosage
    • 650 mg/m2 administered by intravenous infusion over 1 hour daily for 5 consecutive days repeated every 21 days
    • Administer undiluted
    • No dose adjustment recommended for CLCr greater than or equal to 50 mL/min; insufficient data to support a dose recommendation for CLCr less than 50 mL/min
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Adult Dose : 1,500 mg/m 2 administered by intravenous infusion over 2 hours on Days 1, 3, and 5 repeated every 21 days. ( 2.1 ) Pediatric Dose : 650 mg/m 2 administered by intravenous infusion over 1 hour daily for 5 consecutive days repeated every 21 days. ( 2.1 ) Discontinue treatment for neurologic reactions greater than or equal to Grade 2. ( 2.2 ) Dosage may be delayed for hematologic reactions. ( 2.2 ) Take measures to prevent hyperuricemia. ( 2.4 ) 2.1 Recommended Dosage This product is for intravenous use only. Adult Dosage : The recommended adult dose of nelarabine injection is 1,500 mg/m 2 administered by intravenous infusion over 2 hours on Days 1, 3, and 5 repeated every 21 days. Administer nelarabine injection undiluted. Pediatric Dosage : The recommended pediatric dose of nelarabine injection is 650 mg/m 2 administered by intravenous infusion over 1 hour daily for 5 consecutive days repeated every 21 days. Administer nelarabine injection undiluted. The recommended duration of treatment for adult and pediatric patients has not been clearly established. In clinical trials, treatment was generally continued until there was evidence of disease progression, the patient experienced unacceptable toxicity, the patient became a candidate for hematopoietic stem cell transplantation (HSCT), or the patient no longer continued to benefit from treatment. 2.2 Dosage Modification Discontinue nelarabine injection if the patient develops a neurologic adverse reaction of NCI CTCAE Grade 2 or greater. Dosage may be delayed for other toxicity, including hematologic toxicity [see Boxed Warning , Warnings and Precautions (5.1 , 5.2) ]. 2.3 Dosage in Special Populations Nelarabine injection has not been studied in patients with renal or hepatic dysfunction [see Use in Specific Populations (8.6 , 8.7 )] . No dose adjustment is recommended for patients with a creatinine clearance (CLCr) greater than or equal to 50 mL/min [see Clinical Pharmacology (12.3) ] . There are insufficient data to support a dose recommendation for patients with a CLCr less than 50 mL/min. 2.4 Prevention of Hyperuricemia Take precautions against hyperuricemia (e.g., hydration, urine alkalinization, and prophylaxis with allopurinol) [see Warnings and Precautions (5.4) ] .

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Nelarabine Injection side effects

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Nelarabine commonly causes blood cell changes and a range of other effects. The most frequently reported include:

Common side effects

  • Anemia (low red blood cells)
  • Neutropenia (low white blood cells, increasing infection risk)
  • Thrombocytopenia (low platelets, increasing bleeding risk)
  • Nausea, vomiting, or diarrhea
  • Fatigue
  • Headache
  • Dizziness or drowsiness (somnolence)
  • Numbness or tingling (peripheral neuropathy)
  • Nausea, vomiting, diarrhea, or constipation
  • Numbness, tingling, or nerve-related symptoms (peripheral neuropathy)

When to get medical help

  • Call your doctor or go to the ER if you have severe drowsiness, confusion, or altered mental state
  • Seek help immediately for seizures or convulsions
  • Report muscle weakness, difficulty walking, or signs of paralysis right away
  • Tell your care team about numbness, tingling, or loss of sensation that worsens
  • Watch for signs of infection (fever, chills) — low white blood counts make infection dangerous
  • Report unusual bruising or bleeding, which may signal dangerously low platelets
  • Alert your doctor to signs of tumor lysis syndrome: muscle cramping, irregular heartbeat, little or no urine output

Serious reactions — including seizures, muscle paralysis, severe confusion, or signs of infection with a high fever — require immediate medical attention. Do not wait to call your care team if these occur.

Nelarabine Injection warnings and precautions

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  • Neurological toxicity (nerve/brain reactions): This is the most critical risk. Reactions range from drowsiness and tingling to seizures, paralysis, coma, and severe nerve damage resembling Guillain-Barré syndrome. These can appear within days of starting and may not fully reverse even after stopping treatment. Patients who have had intrathecal chemotherapy or craniospinal radiation may be at higher risk.
  • Low blood cell counts: Nelarabine regularly causes significant drops in white blood cells, red blood cells, and platelets, raising the risk of serious infections, anemia, and bleeding. Blood counts must be monitored throughout treatment.
  • Tumor lysis syndrome: When cancer cells die rapidly, they release substances that can disrupt the body's chemistry. Hydration and sometimes medication (such as allopurinol) are used to help prevent this.
  • Fetal harm: Nelarabine can cause serious birth defects. Effective contraception is essential during treatment; men should use condoms for 3 months after the last dose.
  • Live vaccines: Should be avoided during treatment due to immune suppression.
  • Drowsiness and driving: Do not drive or use dangerous equipment until drowsiness has fully resolved.

Nelarabine Injection interactions

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Nelarabine has a small number of known drug interactions, but one is particularly important to avoid:

  • Adenosine deaminase (ADA) inhibitors (e.g., pentostatin): Using these together with nelarabine is not recommended. Since nelarabine relies on the ADA enzyme to convert into its active form, blocking ADA could interfere with how the drug works and may increase toxicity.
  • Live vaccines: Should not be given during treatment because nelarabine suppresses the immune system, making live vaccines potentially dangerous.

Interactions listed in the FDA-approved label

From the Nelarabine Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Adenosine deaminase (ADA) inhibitors, such as pentostatin: Administration of nelarabine injection in combination with ADA inhibitors, such as pentostatin, is not recommended. Combination is not recommended.
Read the label’s full interactions text

7 DRUG INTERACTIONS Administration of nelarabine injection in combination with adenosine deaminase (ADA) inhibitors, such as pentostatin, is not recommended [see Clinical Pharmacology (12.3) ]. Administration in combination with adenosine deaminase (ADA) inhibitors, such as pentostatin, is not recommended. ( 7 , 12.3 )

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Nelarabine Injection

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  • Pregnancy: Nelarabine can cause serious birth defects — tell your doctor if you are pregnant or could become pregnant. Effective contraception is required during treatment.
  • Breastfeeding: Do not breastfeed during treatment; nelarabine may cause serious harm to a nursing infant.
  • Males of reproductive potential: Use condoms during treatment and for 3 months after the last dose, even if you have had a vasectomy.
  • Kidney problems: Reduced kidney function slows the clearance of nelarabine's active form; patients with moderate or severe kidney impairment need close monitoring for increased side effects.
  • Liver problems: Patients with severe hepatic impairment require close monitoring, as their risk of adverse reactions may be higher.
  • Older adults: Those aged 65 and over may have a higher risk of neurological side effects and are more likely to have reduced kidney function — careful monitoring is especially important.
  • Prior intrathecal chemotherapy or craniospinal radiation: These may increase the risk of serious nerve-related side effects from nelarabine.
  • Children: Nelarabine is approved for children aged 1 year and older; blood toxicity tends to be more pronounced in children than adults, while neurological side effects may be somewhat less common.

Nelarabine Injection overdose

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There is no antidote for a nelarabine overdose. Taking too much is expected to cause severe nerve damage (possibly including paralysis or coma), severe suppression of bone marrow (myelosuppression), and could be life-threatening. At doses higher than the standard adult dose, patients have developed serious ascending nerve damage, and imaging has shown changes in the spinal cord consistent with myelin damage. If an overdose is suspected, supportive medical care should be provided immediately.

How your body processes Nelarabine Injection

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After an IV infusion, nelarabine is rapidly and extensively converted by the body into its active form, ara-G — peak levels of ara-G in the blood are typically reached by the end of the infusion and are much higher than nelarabine itself. Nelarabine and ara-G spread widely throughout the body and are not significantly bound to proteins in the blood. Nelarabine is cleared from the blood very quickly (half-life of about 18 minutes in adults), while ara-G lingers a bit longer (half-life around 3 hours in adults; about 2 hours in children). Both are partly eliminated through the kidneys, so reduced kidney function can slow the clearance of ara-G and raise the risk of side effects.

How to store Nelarabine Injection

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Store at 20° to 25°C (68° to 77°F).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

130

Supplements & herbs that interact with Nelarabine Injection

130 supplements and herbal products have documented interactions with Nelarabine Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 6
  • Moderate · 118
  • Minor · 6
Every supplement checked against Nelarabine Injection — ranked by severity The full interaction hub: 6 major · 118 moderate · 6 minor · every one linked to its full report. Check Nelarabine Injection against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Nelarabine Injection: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Nelarabine Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is nelarabine used for?

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Nelarabine (Arranon) is a chemotherapy used for two types of aggressive blood cancers: T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL). It's specifically for patients — adults or children as young as 1 year old — whose cancer has come back or stopped responding to at least two earlier chemotherapy treatments. It's a serious, targeted medicine used when other options haven't worked.

How will I receive this medication — will I need to go to a clinic?

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Yes, absolutely. Nelarabine is given only by IV infusion in a clinical setting — it goes directly into a vein and has to be administered by trained healthcare professionals. You can't take it at home. Adults receive it on Days 1, 3, and 5 of a 21-day cycle; each infusion takes about 2 hours. For children, it's given once daily for 5 days in a row every 21 days, over 1 hour each time. Your care team will set your exact schedule.

What side effects should I really watch out for?

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The most important ones to act on right away are neurological — things like sudden severe drowsiness, confusion, seizures, muscle weakness, numbness or tingling that's getting worse, or trouble walking. These can develop within days of starting treatment. Also watch for signs of serious infection (fever, chills) since your white blood cell count will likely drop. Call your care team immediately — don't wait — if any of these come up. Common but less urgent effects include nausea, fatigue, headache, and low blood counts, which your team will monitor closely.

Is there anything I should avoid while on this treatment?

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A few things matter here. Don't take pentostatin or other drugs that block an enzyme called adenosine deaminase while on nelarabine — that combination is not recommended. Avoid live vaccines during treatment because your immune system will be suppressed. And please don't drive or use heavy machinery if you're feeling drowsy — wait until that fully clears. Staying well hydrated is also important to help protect your kidneys and reduce the risk of a complication called tumor lysis syndrome.

Is this safe if I'm pregnant or trying to have a baby?

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This is really important to discuss with your doctor before starting treatment. Nelarabine can cause serious birth defects — animal studies showed harmful effects at doses lower than the standard human dose. If you could become pregnant, you need to use effective contraception the entire time you're on it. If you're male with a partner who could become pregnant, use condoms during treatment and for 3 months after your last dose. Breastfeeding is also not recommended, as nelarabine could cause serious harm to a nursing baby.

I'm older and have some kidney problems — should I be worried?

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It's definitely something your doctor needs to know about. Nelarabine's active form is partly cleared through the kidneys, so if your kidneys aren't working at full capacity, the drug can build up and increase the risk of side effects — particularly nerve-related ones. Older adults also appear to have a higher rate of neurological reactions in general. Your care team will monitor you more closely and may adjust how they manage your treatment, though the decision on dosing will be based on your specific situation.

Is Nelarabine Injection available over the counter?

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No. Nelarabine Injection is a prescription medicine: every Nelarabine Injection product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Nelarabine Injection first available?

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The earliest FDA record we hold for Nelarabine Injection is from 2005: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Nelarabine Injection was first used.

Who makes Nelarabine Injection?

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14 companies currently list Nelarabine Injection products in the FDA's NDC Directory, including Shorla Oncology Inc., Zydus Pharmaceuticals USA Inc., Alembic Pharmaceuticals Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Nelarabine Injection on HelloPharmacist

Detailed data & references for Nelarabine Injection Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Nelarabine Injection forms and strengths (how it comes)

Nelarabine Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Nelarabine Injection inactive ingredients by manufacturer.

Injection

Into a vein
Brands Arranon
How this form is used
What it may be used for
  • Arranon is used intravenously to treat T-cell acute lymphoblastic leukemia (T-ALL) in adults and children aged 1 year and older whose disease has relapsed or not responded to at least 2 prior chemotherapy regimens
  • Arranon is used intravenously to treat T-cell lymphoblastic lymphoma (T-LBL) in adults and children aged 1 year and older whose disease has relapsed or not responded to at least 2 prior chemotherapy regimens
Important instructions
  • Arranon is administered undiluted by intravenous infusion — it is not diluted before being given
  • For adults, Arranon is infused over 2 hours on Days 1, 3, and 5 of a 21-day treatment cycle
  • For pediatric patients, Arranon is infused over 1 hour once daily for 5 consecutive days every 21 days
  • Arranon should be transferred into a PVC infusion bag or glass container and inspected for particles or discoloration before use
Available strengths 1 strength
27 FDA-listed product records ⓘ

Nelarabine Injection on the U.S. market: products, makers and brands

How Nelarabine Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

14 companies list 16 Nelarabine Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2005. Brand names on the directory include Arranon; the rest are generics.

1
Dose forms ⓘ
14
Labelers (makers, repackagers, distributors)
2
Brand names
16
FDA-listed product records ⓘ
2005
Earliest FDA record ⓘ
Shorla Oncology Inc.13%
Zydus Pharmaceuticals USA Inc.13%
Alembic Pharmaceuticals Inc.6%
Alembic Pharmaceuticals Limited6%
Amneal Pharmaceuticals LLC6%
Dr. Reddy's Laboratories, Inc.6%
Other makers50%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Nelarabine Injection is used (Medicaid data)

A general measure of how commonly Nelarabine Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Nelarabine Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

136
Medicaid prescriptions filled (Q1–Q4 2025)
$159,371 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Nelarabine Injection prescribed? Of the 1,601 medications we measure, Nelarabine Injection ranks #1,477 by Medicaid prescriptions — more than 8% of them.

Where Nelarabine Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Nelarabine Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

50 ML nelarabine 5 MG/ML Injection

136 Medicaid prescriptions (Q1–Q4 2025) 100% of Nelarabine Injection prescriptions shown $159,371 gross reimbursement (before rebates) ≈ $1,172 per prescription (gross)

Summed across the 3 of 32 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 603566

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Nelarabine Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 32 listed Nelarabine Injection NDCs with Medicaid activity.

Compare Nelarabine Injection products

A representative set of FDA-listed product records for Nelarabine Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 16 of 16 products — FDA National Drug Code Directory. See every product, package size and price: browse all 16 Nelarabine Injection NDCs →

Nelarabine Injection recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Nelarabine recall since July 2021, covering 2 product listings. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Feb 13, 2025 · Zydus Pharmaceuticals (USA) Inc
Failed Impurities/Degradation Specifications
  • Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd,… Lots: Lot: a) P300197, Exp. Aug-2025; P400113, Exp. May-26; b) P300169, Exp. Jun-2025; P400115, Exp. May-2026. FDA record D-0256-2025 →
  • Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd,… Lots: Lot: a) P300072, P300073 Exp. Feb-2025; P300153, Exp. Jun-25; P300195, Exp. Aug-2025; P400014, P400017, Exp. Dec-2025; P400070, Exp. Feb-2026; P400112, May-2026; P400142, Exp. Jul-2026; b) P300068, Exp. Feb-2025; P300154, Exp.Jun-2025; P40… FDA record D-0255-2025 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Nelarabine Injection RxCUI 274771 1 dose form · 2 strengths

Look up RxCUI 274771 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Nelarabine Injection brand names

Nelarabine Injection is sold under one brand name in the FDA directory — Arranon. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Arranon

Who makes Nelarabine Injection: manufacturers and labelers

14 companies list Nelarabine Injection products with the FDA. By number of product records, the largest are Shorla Oncology Inc., Zydus Pharmaceuticals USA Inc., Alembic Pharmaceuticals Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Shorla Oncology Inc. 2 Zydus Pharmaceuticals USA Inc. 2 Alembic Pharmaceuticals Inc. 1 Alembic Pharmaceuticals Limited 1 Amneal Pharmaceuticals LLC 1 Dr. Reddy's Laboratories, Inc. 1 Gland Pharma Limited 1 Meitheal Pharmaceuticals Inc 1 Novadoz Pharmaceuticals LLC 1 Novartis Pharmaceuticals Corporation 1 Sagent Pharmaceuticals 1 Sandoz Inc 1 XGen Pharmaceuticals DJB, Inc. 1 Zydus Lifesciences Limited 1

Nelarabine Injection drug class (RxNorm)

Nelarabine Injection belongs to the Nucleoside Metabolic Inhibitor class.

Pharmacologic class Nucleoside Metabolic Inhibitor
Drug family (ATC) Purine analogues
How it works Nucleic Acid Synthesis Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Nelarabine Injection page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Mar 31, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Nelarabine Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Nelarabine Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
15
Finished products in the current FDA directory
16
Companies listing them (makers, repackagers, distributors)
14
FDA labeler codes behind them ⓘ
14
Linked representative label ⓘ
Sandoz Inc
Linked label effective
Mar 31, 2025
Composite sections available
24
Linked SPL Set ID
0f9051de-5c4d-4c0f-8c19-e15214498cca
Linked SPL Document ID
0015d51c-784c-4f0d-938c-6c81decd5903
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Sandoz Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →