MERCAPTOPURINE 20 mg/mL Suspension
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Nucleoside Metabolic Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Mercaptopurine is used alone or with other chemotherapy drugs to treat acute lymphocytic leukemia (ALL; also called acute lymphoblastic leukemia and acute lymphatic leukemia; a type of cancer that begins in the white blood cells). Mercaptopurine is in a class of medications called purine antagonists. It works by stopping the growth of cancer cells.
Read the full MedlinePlus article ↗- Mercaptopurine is a chemotherapy medicine used to help keep acute lymphoblastic leukemia (ALL) — a type of blood cancer — in remission. It's used during the maintenance phase of tr...
- What exactly is mercaptopurine used for?
- Either is fine, but you need to be consistent. Food reduces how much of the medicine your body absorbs, so if you always take it with a meal or always take it without food, your do...
- Should I take this with food or on an empty stomach?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Mercaptopurine — tap one for details:
Mercaptopurine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 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.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $11.75 | $1,174.63 / 100 ml |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Mercaptopurine 20 mg/mL 00054-0879-49 | Hikma | 1 bottle | — | AB | FDA listed | — |
| Mercaptopurine 20 mg/mL 00054-4582-49 | Hikma | 1 bottle | — | AB | FDA listed | — |
| Purixan 20 mg/mL 62484-0020-02 | Nova | 1 bottle | — | AB | FDA listed | — |
| Mercaptopurine 20 mg/mLthis 62484-1020-04 | Nova | 1 bottle | — | AB | FDA listed | — |
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⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 62484-1020-04 You're viewing this | 1 BOTTLE in 1 CARTON (62484-1020-4) / 100 mL in 1 BOTTLE (62484-1020-3) | 2025-09-08 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE MERCAPTOPURINE is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. ( 1.1 )
1.1Acute Lymphoblastic Leukemia MERCAPTOPURINE is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The recommended starting dosage of MERCAPTOPURINE is 1.5 mg/kg to 2.5 mg/kg (50 mg/m 2 to 75 mg/m 2 ) orally once daily as part of a combination chemotherapy maintenance regimen. Adjust dose to maintain desirable absolute neutrophil count and for excessive myelosuppression. ( 2.1 ) Renal Impairment : Use the lowest recommended starting dose or increase the dosing interval.
( 2.3, 8.6 ) Hepatic Impairment : Use the lowest recommended starting dose. ( 2.3, 8.7 )
2.1Recommended Dosage The recommended starting dose of MERCAPTOPURINE is 1.5 mg/kg to 2.5 mg/kg (50 mg/m 2 to 75 mg/m 2 ) orally once daily as part of combination chemotherapy maintenance regimen. Take MERCAPTOPURINE either consistently with or without food [see Clinical Pharmacology (12.3) ]. After initiating MERCAPTOPURINE, monitor complete blood counts (CBC) and adjust the dose to maintain absolute neutrophil count (ANC) at a desirable level and for excessive myelosuppression.
Evaluate the bone marrow in patients with prolonged myelosuppression or repeated episodes of myelosuppression to assess leukemia status and marrow cellularity. Evaluate thiopurine S-methyltransferase (TPMT) and nucleotide diphosphatase (NUDT15) status in patients with severe myelosuppression or repeated episodes of myelosuppression [see Dosage and Administration (2.2) ]. If a patient misses a dose, instruct the patient to continue with the next scheduled dose.
2.2Dosage Modifications in Patients with TPMT and/or NUDT15 Deficiency Consider testing for TPMT and NUDT15 deficiency in patients who experience severe myelosuppression or repeated episodes of myelosuppression [see Warnings and Precautions (5.1) , Clinical Pharmacology (12.5) ]. Homozygous Deficiency in either TPMT or NUDT15 Patients with homozygous deficiency of either enzyme typically require 10% or less of the recommended dosage. Reduce the recommended starting dosage of MERCAPTOPURINE in patients who are known to have homozygous TPMT or NUDT15 deficiency.
Heterozygous Deficiency in TPMT and/or NUDT15 Reduce the MERCAPTOPURINE dosage based on tolerability. Most patients with heterozygous TPMT or NUDT15 deficiency tolerate recommended dosage, but some require dose reduction based on adverse reactions. Patients who are heterozygous for both TPMT and NUDT15 may require more substantial dose reductions.
2.3Dosage Modifications in Renal and Hepatic Impairment Renal Impairment Use the lowest recommended starting dosage for MERCAPTOPURINE or increase the dosing interval to every 36 to 48 hours in patients with renal impairment (CLcr less than 50 mL/min). Adjust the dosage to maintain absolute neutrophil count (ANC) at a desirable level and for adverse reactions [see Use in Specific Populations (8.6) ]. Hepatic Impairment Use the lowest recommended starting dosage for MERCAPTOPURINE in patients with hepatic impairment.
Adjust the dosage to maintain absolute neutrophil count (ANC) at a desirable level and for adverse reactions [see Use in Specific Populations (8.7) ].
2.4Dosage Modification with Concomitant Use of Allopurinol Reduce the dose of MERCAPTOPURINE to one-third to one-quarter of the current dosage when coadministered with allopurinol [see Drug Interactions (7.1) ].
2.5Administration Shake the bottle vigorously for at least 30 seconds to ensure the oral suspension is well mixed. MERCAPTOPURINE is a pink to brown viscous oral suspension. Provide a press-in bottle adapter and two oral dispensing syringes (one 1 mL and one 5 mL).
Train patients or caregivers on proper handling, storage, administration, disposal and clean-up of accidental spillage prior to initiation of MERCAPTOPURINE and during each visit to the clinic. Advise patients and caregivers to use MERCAPTOPURINE within 8 weeks and properly discard remaining MERCAPTOPURINE after 8 weeks. Provide instructions regarding which syringe to use and how to administer the specified dose, since MERCAPTOPURINE is supplied with 1 mL and 5 mL oral dispensing…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Oral suspension: 2,000 mg/100 mL (20 mg/mL). ( 3 ) Oral Suspension: 2,000 mg/100 mL (20 mg/mL) pink to brown in color.
⛔ Contraindications ▾
4 CONTRAINDICATIONS None None.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Myelosuppression : Monitor complete blood count (CBC) and adjust the dose of MERCAPTOPURINE for excessive myelosuppression. Consider testing in patients with severe myelosuppression or repeated episodes of myelosuppression for thiopurine S-methyltransferase (TPMT) or nucleotide diphosphatase (NUDT15) deficiency. Patients with homozygous-TPMT or homozygous-NUDT15 deficiency may require a dose reduction.
( 2.2, 5.1 ) Hepatotoxicity : Monitor transaminases, alkaline phosphatase and bilirubin. Withhold MERCAPTOPURINE at onset of hepatotoxicity. ( 5.2 ) Immunosuppression :Response to all vaccines may be diminished and there is a risk of infection with live virus vaccines.
Consult immunization guidelines for immunocompromised pediatrics. ( 5.3 ) Treatment Related Malignancies : Aggressive and fatal cases of hepatosplenic T-cell lymphoma have occurred. ( 5.4 ) Macrophage Activation Syndrome : Monitor for and treat promptly; discontinue MERCAPTOPURINE.
( 5.5 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.6 , 8.1, 8.3 )
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reaction (> 20%) is myelosuppression including anemia, neutropenia, lymphopenia and thrombocytopenia. Adverse reactions occurring in 5% to 20% of patients include anorexia, nausea, vomiting, diarrhea, malaise and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rare Disease Therapeutics, Inc., at 1-844-472-7389 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions (5.1) ] Hepatotoxicity [see Warnings and Precautions (5.2) ] Immunosuppression [see Warnings and Precautions (5.3) ] Treatment Related Malignancies [see Warnings and Precautions (5.4) ] Macrophage Activation Syndrome [see Warnings and Precautions (5.5) ]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Allopurinol : Reduce the dose of MERCAPTOPURINE when co-administered with allopurinol. ( 2.4 , 7.1 ) Warfarin : MERCAPTOPURINE may decrease the anticoagulant effect. Monitor INR and adjust warfarin dose as appropriate. ( 7.2 ) See FDA approved patient labeling and
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation : Advise not to breastfeed. ( 8.2 ) Infertility : Can impair fertility. ( 8.3 )
🆘 Overdosage ▾
10 OVERDOSAGE Signs and symptoms of mercaptopurine overdosage may be immediate (anorexia, nausea, vomiting, and diarrhea) or delayed (myelosuppression, liver dysfunction, gastroenteritis, and mucosal inflammation). Dialysis cannot be expected to clear mercaptopurine. Hemodialysis is thought to be of marginal use due to the rapid intracellular incorporation of mercaptopurine into active metabolites with long persistence.
Withhold MERCAPTOPURINE immediately if severe or life-threatening adverse reactions occur during treatment. If a patient is seen immediately following an accidental overdosage, it may be useful to induce emesis.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Mercaptopurine is a purine analog that undergoes intracellular transport and activation to form metabolites including thioguanine nucleotides (TGNs). Incorporation of TGNs into DNA or RNA results in cell-cycle arrest and cell death. TGNs and other mercaptopurine metabolites are also inhibitors of de novo purine synthesis and purine nucleotide interconversions.
Mercaptopurine was cytotoxic to proliferating cancer cells in vitro and had antitumor activity in mouse tumor models. It is not known which of the biochemical effects of mercaptopurine and its metabolites are directly or predominantly responsible for cell death.
12.2Pharmacodynamics Exposure-Response Relationships Mercaptopurine exposure-response relationships and the time course of pharmacodynamics response are unknown.
12.3Pharmacokinetics Following a single oral dose of MERCAPTOPURINE 50 mg under fasted conditions to adult healthy subjects, the median (min – max) AUC 0-INF was 137 h∙ng/mL (77 – 268 h∙ng/mL) and C max was 93 ng/mL (40 – 204 ng/mL). Absorption MERCAPTOPURINE is absorbed after oral administration with a median (min – max) T max of 0.75 (0.33 – 2.5) hours. Effect of foods Food has been shown to decrease the exposure of mercaptopurine.
Distribution The volume of distribution exceeds total body water with a mean volume of distribution of approximately
0.9L/kg. There is negligible entry of mercaptopurine into cerebrospinal fluid. Plasma protein binding averages 19% over the concentration range 10 to 50 mcg/L.
Elimination The median (min – max) elimination half-life (t 1/2 ) was 1.3 (0.9 – 5.4) hours. Metabolism Mercaptopurine is inactivated via two major pathways. One is thiol methylation, which is catalyzed by the polymorphic enzyme thiopurine S-methyltransferase (TPMT), to form the inactive metabolite methyl-mercaptopurine.
The second inactivation pathway is oxidation, which is catalyzed by xanthine oxidase. The product of oxidation is the inactive metabolite 6-thiouric acid. Elimination After oral administration of mercaptopurine, urine contains intact mercaptopurine, thiouric acid (formed by direct oxidation by xanthine oxidase, probably via 6-mercapto-8-hydroxypurine), and a number of 6-methylated thiopurines.
In one subject, a total of 46% of the dose could be accounted for in the urine (as parent drug and metabolites) in the first 24 hours. Specific Populations Pediatrics Patients Wide inter individual variations in systemic exposure is observed. Following oral administration of 50 mg/m 2 mercaptopurine in 10 children, median plasma concentrations 1 hour post dose was 0.35 (range 0.03 to 1.03) μM and median AUC1 –5hours was 56 (range 23 to 65) μM·min.
Tmax ranged from 1 to 3 hours. Drug Interactions Studies Methotrexate: Mercaptopurine AUC increased by approximately 31% when coadministered with oral methotrexate 20 mg/m 2 . Mercaptopurine AUC increased by 69% when coadministered with IV methotrexate 2 g/m 2 , and by 93% when coadministered with IV methotrexate 5 g/m 2 .
12.5Pharmacogenomics Several published studies indicate that patients with reduced TPMT or NUDT15 activity receiving usual doses of mercaptopurine, accumulate excessive cellular concentrations of active 6-TGNs, and are at higher risk for severe myelosuppression [see Warnings and Precautions (5.1) ]. In a study of 1028 children with ALL, the approximate tolerated mercaptopurine dosage for patients with TPMT and/or NUDT15 deficiency on mercaptopurine maintenance therapy (as a percentage of the planned dosage) was as follows: heterozygous for either TPMT or NUDT15, 50-90%; heterozygous for both TPMT and NUDT15, 30-50%; homozygous for either TPMT or NUDT15, 5-10%.
Approximately 0.3% (1:300) of patients of European or African ancestry have two loss-of-function alleles of the TPMT gene and have little or no TPMT activity (homozygous deficient or poor metabolizers), and approximately 10% of patients have one loss-of-function TPMT allele le…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Mercaptopurine is a purine analog that undergoes intracellular transport and activation to form metabolites including thioguanine nucleotides (TGNs). Incorporation of TGNs into DNA or RNA results in cell-cycle arrest and cell death. TGNs and other mercaptopurine metabolites are also inhibitors of de novo purine synthesis and purine nucleotide interconversions.
Mercaptopurine was cytotoxic to proliferating cancer cells in vitro and had antitumor activity in mouse tumor models. It is not known which of the biochemical effects of mercaptopurine and its metabolites are directly or predominantly responsible for cell death.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING MERCAPTOPURINE oral suspension is supplied as 2,000 mg/100 mL (20 mg/mL) pink to brown viscous liquid in amber glass multiple-dose bottles. In addition, a press-in bottle adapter and two oral dispensing syringes (one 1 mL and one 5 mL) are provided. Each carton NDC 62484-1020-4 contains 1 bottle of MERCAPTOPURINE NDC 62484-1020-3.
Store MERCAPTOPURINE between 59ºF to 77ºF (15ºC to 25ºC). Store in a dry place. MERCAPTOPURINE is a hazardous drug.
Follow special handling and disposal procedures. 1
📋 Description ▾
11 DESCRIPTION Mercaptopurine, a nucleoside metabolic inhibitor. The chemical name is 1,7-dihydro-6H-purine-6-thione monohydrate. The molecular formula is C 5 H 4 N 4 S•H 2 O and the molecular weight is 170.20.
The structural formula is: Mercaptopurine is a yellow, odorless or practically odorless, crystalline powder. It is practically insoluble in water with pKa 7.8, 11.2. MERCAPTOPURINE oral suspension contains 2,000 mg/100 mL (20 mg/mL) of mercaptopurine.
The suspension also contains the following inactive ingredients: xanthan gum, aspartame, concentrated raspberry juice, sucrose, ethyl parahydroxybenzoate sodium, methyl parahydroxybenzoate sodium, potassium sorbate, sodium hydroxide and purified water. MERCAPTOPURINE is a pink to brown viscous suspension. structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patients and caregivers to read the FDA-approved patient labelling (Patient Information and Instructions for Use). Major Adverse Events Advice patients and caregivers that MERCAPTOPURINE can cause myelosuppression, hepatotoxicity, and gastrointestinal toxicity. Advise patients to contact their healthcare provider if they experience fever, sore throat, jaundice, nausea, vomiting, signs of local infection, bleeding from any site, or symptoms suggestive of anemia [see Warnings and Precautions (5.1 , 5.2 , 5.3) ].
Proper Preparation and Administration Advise patients or caregivers on proper handling, storage, preparation, administration, and disposal and clean-up of accidental spillage of the medication prior to initiation and on each visit to the clinic [see Dosage and Administration (2.5) ]. Embryo-Fetal Toxicity Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.2, 5.6) , Use in Specific Populations (8.1) ].
Advise females of reproductive potential to use effective contraception during treatment with MERCAPTOPURINE and for 6 months after the last dose [see Use in Specific Populations (8.3) ]. Advise males with female partners of reproductive potential to use effective contraception during treatment with MERCAPTOPURINE and for 3 months after the last dose [see Use in Specific Populations (8.3) , Nonclinical Toxicology (13.1) ]. Lactation Advise women not to breastfeed during treatment with MERCAPTOPURINE and for 1 week after the last dose [see Use in Specific Populations (8.2) ].
Infertility Advise males and females of reproductive potential that MERCAPTOPURINE can impair fertility [see Use in Specific Populations (8.3) ]. Other Adverse Reactions Instruct patients to minimize sun exposure due to risk of photosensitivity [see Adverse Reactions (6.2) ]. Manufactured by: Nova Laboratories Ltd Leicester LE 18 4YL United Kingdom Manufactured for: Rare Disease Therapeutics 2550 Meridian Blvd., Suite 150 Franklin, TN 37067 www.raretx.com Part Number: D001518/1