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MERCAPTOPURINE 20 mg/mL Suspension — NDC 00054-0879-49 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

MERCAPTOPURINE 20 mg/mL Suspension — NDC 0054-0879-49 (Billing 00054-0879-49)

by Hikma Pharmaceuticals USA Inc. · 1 BOTTLE, GLASS in 1 CARTON / 100 mL in 1 BOTTLE, GLASS

This is a package of MERCAPTOPURINE 20 mg/mL Suspension from Hikma Pharmaceuticals USA Inc., marketed since Jun 2025 and currently FDA-listed. It is this product's only package size.

NDC 00054-0879-49
🏷️ FDA NDC (as labeled) 0054-0879-49 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 20, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0054-0879-49
Product NDC 0054-0879
11-digit billing NDC 00054087949
NCPDP billing unit ML — per mL (volume)
RxCUI 1536484
UNII E7WED276I5
Application # ANDA216418
SPL Set ID 0a366cf3-91f0-4aa4-8f34-a7a27cad8f15
Established class (EPC) Nucleoside Metabolic Inhibitor
Mechanism of action Nucleic Acid Synthesis Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-16
Route ORAL
Dosage form SUSPENSION
Substance MERCAPTOPURINE
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 069994
GCN 33277
HICL code 003908
Ingredient (HICL) Mercaptopurine
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1B
Therapeutic class — specific (HIC3) Antineoplastic - Antimetabolites
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name MERCAPTOPURINE 20 MG/ML SUSPEN
FDB brand name Mercaptopurine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 069994
  • GCN: 33277
  • HICL (First Databank): 003908
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 1536484
Why two NDCs? The FDA registers this code as 0054-0879-49 — a 4-4-2 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 labeler segment → 00054-0879-49. 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 Nucleoside Metabolic Inhibitor class.

Pharmacologic class Nucleoside Metabolic Inhibitor
Drug family (ATC) Purine analogues
How it works Nucleic Acid Synthesis 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 MERCAPTOPURINE 20 MG/ML SUSPEN Ingredient Mercaptopurine
📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • 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?
📖 Read our full Mercaptopurine guide →
1
Nutrient depletion considerations

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

🧪 Full Mercaptopurine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $11.34 $1,133.53 / 100 ml
Medicare drug plans payPart D · Q2 2026 $11.75 $1,174.63 / 100 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00054-0879-49 You're viewing this Main listing 1 BOTTLE, GLASS in 1 CARTON / 100 mL in 1 BOTTLE, GLASS 2025-06-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mercaptopurine 20 mg/mLthis 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/mL 62484-1020-04 Nova 1 bottle — AB 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

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year 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.

What it looks like

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

Inactive Ingredients / Excipients

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

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

  • UNII Z0H242BBR1
    Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
  • UNII 9G5L16BK6N
    A thick, sweet liquid made from corn starch. It acts as a sweetener, thickener, and binder in medicines, helping create the right texture and taste while holding ingredients together.
  • UNII Z0D00IVA10
    A salt form of ethylparaben, a synthetic preservative derived from benzoic acid. It prevents bacterial and fungal growth in medicines to extend shelf life and maintain product safety during storage.
  • 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.
  • UNII CR6K9C2NHK
    A synthetic preservative derived from methylparaben. It prevents bacterial and fungal growth in medicines, extending shelf life and maintaining product safety during storage.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII 427AYI9PDE
    A natural flavoring derived from raspberries that adds taste to the medicine. It helps mask bitter or unpleasant flavors to make the medication easier to take.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

12 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

LabelerHikma Pharmaceuticals USA Inc.
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationANDA216418 (ANDA)
Labeler code00054
First marketedJun 2025
Product typeHuman Prescription Drug
Portfolio726 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 57 words ▾

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 ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • The recommended starting dosage of mercaptopurine oral suspension 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 oral suspension 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 oral suspension 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 oral suspension 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 oral suspension and during each visit to the clinic. Advise patients and caregivers to use mercaptopurine oral suspension within 8 weeks and properly discard remaining mercaptopurine oral suspension after 8 weeks. Provide instructions regardi… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 27 words ▾

3 DOSAGE FORMS AND STRENGTHS Oral Suspension: 2,000 mg/100 mL (20 mg/mL) pink to brown in color. Oral suspension: 2,000 mg/100 mL (20 mg/mL) ( 3 )

⛔ Contraindications 5 words ▾

4 CONTRAINDICATIONS None. • None

⚠️ Warnings and Cautions ~3 min read ▾

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 ) • Phenylketonuria : Patients should be informed that mercaptopurine oral suspension contains phenylalanine, a component of aspartame.

Each mL of the 20 mg/mL oral suspension contains 0.015 mg of phenylalanine. ( 5.7 )

5.1Myelosuppression The most consistent, dose-related adverse reaction of mercaptopurine is myelosuppression, manifested by anemia, leukopenia, thrombocytopenia, or any combination of these. Monitor CBC and adjust the dosage of mercaptopurine for excessive myelosuppression [see Dosage and Administration ( 2.1 )] . Consider testing for thiopurine S-methyltransferase (TPMT) or nucleotide diphosphatase (NUDT15) deficiency in patients with severe myelosuppression or repeated episodes of myelosuppression.

TPMT genotyping or phenotyping (red blood cell TPMT activity) and NUDT15 genotyping can identify patients who have reduced activity of these enzymes. Patients with homozygous TPMT or NUDT15 deficiency may require a dose reduction [see Dosage and Administration ( 2.2 ), Clinical Pharmacology ( 12.5 )] . Myelosuppression can be exacerbated by coadministration with allopurinol, aminosalicylates or other products that cause myelosuppression [see Drug Interactions ( 7.1 , 7.3 , 7.4 )] .

Reduce the dosage of mercaptopurine when coadministered with allopurinol [see Dosage and Administration ( 2.4 )] .

5.2Hepatotoxicity Mercaptopurine is hepatotoxic. There are reports of deaths attributed to hepatic necrosis associated with the administration of mercaptopurine. Hepatic injury can occur with any dosage but seems to occur with greater frequency when the recommended dosage is exceeded.

In some patients, jaundice has cleared following withdrawal of mercaptopurine and reappeared with rechallenge. Usually, clinically detectable jaundice appears early in the course of treatment (1 to 2 months); however, jaundice has been reported as early as 1 week and as late as 8 years after starting mercaptopurine. The hepatotoxicity has been associated in some cases with anorexia, diarrhea, jaundice, ascites, and pruritus.

Hepatic encephalopathy has occurred. Monitor serum transaminase levels, alkaline phosphatase, and bilirubin levels at weekly intervals when first beginning therapy and at monthly intervals thereafter. Monitor liver tests more frequently in patients who are receiving mercaptopurine with other hepatotoxic drugs [see Drug Interactions ( 7.5 )] or with known pre-existing liver disease.

Withhold mercaptopurine at onset of hepatotoxicity. Intrahepatic Cholestasis of Pregnancy Postmarketing cases of intrahepatic cholestasis of pregnancy (ICP) have been reported in patients with inflammatory bowel disease who received mercaptopurine during pregnancy. Mercaptopurine is not indicated for use in inflammatory bowel disease [see Indications and Usage ( 1.1 )] .

Discontinue m… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Myelosuppression [see Warnings and Precautions ( 5.1 )] • Hepatotoxicity [see Warnings and Precautions ( 5.2 )] • 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 )] 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 Hikma Pharmaceuticals USA Inc. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Based on multicenter cooperative group ALL trials, the most common adverse reaction occurring in > 20% of patients was myelosuppression, including anemia, neutropenia, lymphopenia and thrombocytopenia. Adverse reactions occurring in 5% to 20% of patients included anorexia, nausea, vomiting, diarrhea, malaise, and rash.

Adverse reactions occurring in < 5% of patients included urticaria, hyperuricemia, oral lesions, elevated transaminases, hyperbilirubinemia, hyperpigmentation, infections, and pancreatitis. Oral lesions resemble thrush rather than antifolic ulcerations. Delayed or late toxicities include hepatic fibrosis, hyperbilirubinemia, alopecia, pulmonary fibrosis, oligospermia and secondary malignancies [see Warnings and Precautions ( 5.1 , 5.2 )] .

Drug fever has been reported with mercaptopurine.

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of mercaptopurine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include: photosensitivity, hypoglycemia, portal hypertension, intrahepatic cholestasis of pregnancy (ICP), pellagra, erythema nodosum, and mucosal inflammation.

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS • Allopurinol : Reduce the dose of mercaptopurine when coadministered with allopurinol. ( 2.4 , 7.1 ) • Warfarin : Mercaptopurine may decrease the anticoagulant effect. Monitor INR and adjust warfarin dose as appropriate. ( 7.2 )

7.1Allopurinol Allopurinol can inhibit the first-pass oxidative metabolism of mercaptopurine by xanthine oxidase, which can lead to an increased risk of mercaptopurine adverse reactions [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 )] . Reduce the dose of mercaptopurine when coadministered with allopurinol [see Dosage and Administration ( 2.4 )] .

7.2Warfarin The coadministration of mercaptopurine with warfarin may decrease the anticoagulant effectiveness of warfarin. Monitor the international normalized ratio (INR) in patients receiving warfarin and adjust the warfarin dosage as appropriate.

7.3Myelosuppressive Products Mercaptopurine can cause myelosuppression. Myelosuppression may be increased when mercaptopurine is coadministered with other drugs that cause myelosuppression. Enhanced myelosuppression has been noted in some patients receiving trimethoprim-sulfamethoxazole. Monitor the CBC and adjust the dose of mercaptopurine for excessive myelosuppression [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.1 )] .

7.4Aminosalicylates Aminosalicylates (e.g., mesalamine, olsalazine or sulfasalazine) may inhibit the TPMT enzyme, which may increase the risk of myelosuppression when coadministered with mercaptopurine. When aminosalicylates and mercaptopurine are coadministered, use the lowest possible doses for each drug and monitor more frequently for myelosuppression [see Warnings and Precautions ( 5.1 )] .

7.5Hepatotoxic Products Mercaptopurine can cause hepatotoxicity. Hepatotoxicity may be increased when mercaptopurine is coadministered with other products that cause hepatotoxicity. Monitor liver tests more frequently in patients who are receiving mercaptopurine with other hepatotoxic products [see Warnings and Precautions ( 5.2 )] .

7.6Methotrexate Mercaptopurine dosage may need adjustment when administered concomitantly with high dose methotrexate [see Warnings and Precautions ( 5.1 )] . Mercaptopurine exposure increases with concomitant methotrexate use [see Clinical Pharmacology ( 12.3 )] which may increase the risk of mercaptopurine adverse reactions. The mechanism of this interaction has not been fully characterized [see Clinical Pharmacology ( 12.3 )] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Lactation : Advise not to breastfeed. ( 8.2 ) • Infertility : Can impair fertility. ( 8.3 )

8.1Pregnancy Risk Summary Mercaptopurine can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . Pregnant women who receive mercaptopurine have an increased incidence of miscarriage and stillbirth (see Data ) . Advise pregnant women of the potential risk to a fetus.

The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Human Data Women receiving mercaptopurine in the first trimester of pregnancy have an increased incidence of miscarriage; the risk of malformation in offspring surviving first trimester exposure is not known. In a series of 28 women receiving mercaptopurine after the first trimester of pregnancy, 3 mothers died prior to delivery, 1 delivered a stillborn child, and 1 aborted; there were no cases of macroscopically abnormal fetuses. Animal Data Mercaptopurine was embryo-lethal and teratogenic in several animal species (rat, mouse, rabbit, and hamster) at doses less than the recommended human dose.

8.2Lactation Risk Summary There are no data on the presence of mercaptopurine or its metabolites in human milk, the effects on the breastfed child or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with mercaptopurine and for 1 week after the last dose.

8.3Females and Males of Reproductive Potential Mercaptopurine can cause fetal harm when administered to pregnant women [see Use in Specific Populations ( 8.1 )] . Pregnancy Testing Verify the pregnancy status in females of reproductive potential prior to initiating mercaptopurine [see Use in Specific Populations ( 8.1 )] . Contraception Females Advise females of reproductive potential to use effective contraception during treatment with mercaptopurine and for 6 months after the last dose.

Males Based on genotoxicity findings, 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 Nonclinical Toxicology ( 13.1 )] . Infertility Females and Males Based on findings from animal studies, mercaptopurine can impair female and male fertility [see Nonclinical Toxicology ( 13.1 )] . The long-term effects of mercaptopurine on female and male fertility, including the reversibility have not been studied.

8.4Pediatric Use Safety and effectiveness of mercaptopurine have been established in pediatric patients. Use of mercaptopurine in pediatrics is supported by evidence from the published literature and clinical experience. Symptomatic hypoglycemia has been reported in pediatric patients with ALL receiving mercaptopurine. Reported cases were in pediatrics less than 6 years or with a low body mass index.

8.5Geriatric Use Clinical studies of mercaptopurine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or another drug therapy.

8.6Renal 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 dose to… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 198 words ▾

8.1Pregnancy Risk Summary Mercaptopurine can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . Pregnant women who receive mercaptopurine have an increased incidence of miscarriage and stillbirth (see Data ) . Advise pregnant women of the potential risk to a fetus.

The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Human Data Women receiving mercaptopurine in the first trimester of pregnancy have an increased incidence of miscarriage; the risk of malformation in offspring surviving first trimester exposure is not known. In a series of 28 women receiving mercaptopurine after the first trimester of pregnancy, 3 mothers died prior to delivery, 1 delivered a stillborn child, and 1 aborted; there were no cases of macroscopically abnormal fetuses. Animal Data Mercaptopurine was embryo-lethal and teratogenic in several animal species (rat, mouse, rabbit, and hamster) at doses less than the recommended human dose.

🧒 Pediatric Use 58 words ▾

8.4Pediatric Use Safety and effectiveness of mercaptopurine have been established in pediatric patients. Use of mercaptopurine in pediatrics is supported by evidence from the published literature and clinical experience. Symptomatic hypoglycemia has been reported in pediatric patients with ALL receiving mercaptopurine. Reported cases were in pediatrics less than 6 years or with a low body mass index.

🧓 Geriatric Use 83 words ▾

8.5Geriatric Use Clinical studies of mercaptopurine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or another drug therapy.

🆘 Overdosage 83 words ▾

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 ~3 min read ▾

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 Food 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 Pediatric 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 AUC 1–5hours was 56 (range 23 to 65) μM·min.

T max 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 l… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 92 words ▾

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 93 words ▾

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 0054-0879-49 contains 1 bottle of Mercaptopurine Oral Suspension NDC 0054-0879-49. • Store Mercaptopurine Oral Suspension at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

Store in a dry place. Mercaptopurine is a hazardous drug. Follow special handling and disposal procedures.

1

📋 Description 130 words ▾

11 DESCRIPTION Mercaptopurine is a nucleoside metabolic inhibitor. The chemical name is 6 H -purine-6-thione, 1,7-dihydro-, 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, USP is a yellow, crystalline powder; odorless. It is practically insoluble in water and in ether; slightly soluble in ethanol (96%). It dissolves in solutions of alkali hydroxides; pKa 7.8, 11.2.

Mercaptopurine oral suspension contains 2,000 mg/100 mL (20 mg/mL) of mercaptopurine, USP. The suspension also contains the following inactive ingredients: aspartame, ethylparaben sodium, hydrochloric acid, methylparaben sodium, potassium sorbate, raspberry juice powder (raspberry juice, rice syrup solids, silicon dioxide), sodium hydroxide, sucrose, water (purified), xanthan gum. Mercaptopurine oral suspension is a pink to brown viscous suspension.

Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patients and caregivers to read the FDA-approved patient labelling (Patient Information and Instructions for Use). Major Adverse Reactions Advise 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 )] .

Patients with Phenylketonuria Inform patients with phenylketonuria that each mL of mercaptopurine oral suspension contains 0.015 mg of phenylalanine [see Warnings and Precautions ( 5.7 )] . Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50001544/02 Revised July 2026

🧬 Pharmacokinetics ~2 min read ▾

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 Food 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 Pediatric 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 AUC 1–5hours was 56 (range 23 to 65) μM·min.

T max 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 .

🧬 Pharmacodynamics 16 words ▾

12.2Pharmacodynamics Exposure-Response Relationships Mercaptopurine exposure-response relationships and the time course of pharmacodynamics response are unknown.

🧪 Nonclinical Toxicology 76 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Mercaptopurine is carcinogenic in animals. Mercaptopurine causes chromosomal aberrations in cells derived from animals and humans and induces dominant-lethal mutations in the germ cells of male mice. Mercaptopurine can impair fertility.

In mice, surviving female offspring of mothers who received chronic low doses of mercaptopurine during pregnancy were found sterile, or if they became pregnant, had smaller litters and more dead fetuses as compared to control animals.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 73 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Mercaptopurine is carcinogenic in animals. Mercaptopurine causes chromosomal aberrations in cells derived from animals and humans and induces dominant-lethal mutations in the germ cells of male mice. Mercaptopurine can impair fertility.

In mice, surviving female offspring of mothers who received chronic low doses of mercaptopurine during pregnancy were found sterile, or if they became pregnant, had smaller litters and more dead fetuses as compared to control animals.

📚 References 8 words ▾

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

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION PATIENT INFORMATION Mercaptopurine (mer kapʺ toe pureʹ een) Oral Suspension What is Mercaptopurine Oral Suspension? Mercaptopurine Oral Suspension is a prescription medicine used along with other medicines to treat people with acute lymphoblastic leukemia (ALL). What should I tell my healthcare provider before taking Mercaptopurine Oral Suspension?

Before you take Mercaptopurine Oral Suspension, tell your healthcare provider about all of your medical conditions , including if you: • have kidney or liver problems. • have a condition where your body produces too little of the enzyme thiopurine methyltransferase (TPMT) or the enzyme nucleotide diphosphatase (NUDT15). • have phenylketonuria (PKU). Mercaptopurine contains phenylalanine which is a part of aspartame. • have recently received or plan to receive a vaccine. • are pregnant or plan to become pregnant. Mercaptopurine Oral Suspension can harm your unborn baby.

If you are a female who is able to become pregnant: o Your healthcare provider will do a pregnancy test before you start treatment with Mercaptopurine Oral Suspension. o Use an effective method of birth control (contraception) during treatment with Mercaptopurine Oral Suspension and for 6 months after your last dose. Talk with your healthcare provider about birth control methods you can use during this time. o Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Mercaptopurine Oral Suspension.

If you are a male with a female partner who is able to become pregnant: o Use effective birth control (contraception) during treatment with Mercaptopurine Oral Suspension and for 3 months after your last dose. o Tell your healthcare provider right away if your female partner becomes pregnant or thinks she is pregnant during your treatment with Mercaptopurine Oral Suspension. • are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with Mercaptopurine Oral Suspension and for at least 1 week after your last dose. • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take Mercaptopurine Oral Suspension? • See the detailed “Instructions for Use” that comes with Mercaptopurine Oral Suspension for information about the right way to measure and take a dose of Mercaptopurine Oral Suspension. • Take Mercaptopurine Oral Suspension exactly as your healthcare provider tells you. Do not stop taking Mercaptopurine Oral Suspension or change your dose without talking to your healthcare provider. • Take Mercaptopurine Oral Suspension by mouth 1 time each day. • If Mercaptopurine Oral Suspension comes into contact with skin, eyes, or clothes? • Remove contaminated clothing. • Wash skin or eyes immediately with water. • Contact with skin or eyes can cause hypersensitive reactions resulting in rash, redness, itching and inflammation.

If symptoms appear seek medical attention. • During treatment with Mercaptopurine Oral Suspension, your healthcare provider will do blood tests regularly to check your blood cell counts and liver function. Your healthcare provider may change your dose if you have side effects. • If you miss a dose of Mercaptopurine Oral Suspension, call your healthcare provider for advice. • If you take too much Mercaptopurine Oral Suspension, call your healthcare provider or go to the nearest emergency room right away. What should I avoid while taking Mercaptopurine Oral Suspension?

Mercaptopurine Oral Suspension can make your skin more sensitive to sunlight. Protect yourself from sunlight during treatment with Mercaptopurine Oral Suspension. What are the possible side effects of Mercaptopurine Oral Suspension?

Mercaptopurine Oral Suspension can cause serious side effects, including: • Decreased blood cell counts are common with Mercaptopurine Oral Suspension but can also be severe. Mercaptopurine Oral Suspension affects you… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE INSTRUCTIONS FOR USE Mercaptopurine (mer kapʺ toe pureʹ een) Oral Suspension 20 mg/mL Read these Instructions for Use before you start taking Mercaptopurine Oral Suspension, and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Important information about measuring Mercaptopurine Oral Suspension • Always use the oral dispensing syringe provided with your Mercaptopurine Oral Suspension to make sure you measure the right amount. • You will be provided: • 1 bottle of Mercaptopurine Oral Suspension • 1 bottle adapter • 2 oral dispensing syringes (one 1 mL and one 5 mL) If you did not receive an oral dispensing syringe with your Mercaptopurine Oral Suspension, ask your pharmacist to give you one. You will also need disposable gloves. Important Information You Need to Know Before Administering Mercaptopurine Oral Suspension: 1.

Wash your hands well with soap and water before and after administering a dose. 2. Put on disposable gloves before handling Mercaptopurine Oral Suspension.

3. Shake the bottle vigorously for at least 30 seconds to make sure that the medicine is well mixed (See Figure A ) . Figure A 4.

Remove the child-resistant bottle cap (See Figure B ). Figure B 5. Push the smaller end of the bottle adapter into the neck of the bottle until it is firmly in place.

The bottom edge of the adapter should fully contact the top rim of the bottle (See Figure C ). Do not remove the adapter from the bottle after it is inserted. Figure C Preparing a dose of Mercaptopurine Oral Suspension: 6.

Hold the bottle upright. Remove the bottle cap by turning in the direction of the arrow (See Figure B ). 7.

Push the tip of the oral dispensing syringe into the hole in the bottle adapter (See Figure D and Figure E ). Figure D Figure E 8. Turn the bottle upside down (See Figure F ).

Figure F 9. Pull back slowly on the plunger of the oral dispensing syringe to withdraw the prescribed dose of Mercaptopurine Oral Suspension. Pull the plunger back to the mL mark on the syringe that corresponds to the dose prescribed ( Figure F ).

If you are not sure about how much medicine to draw into the oral dispensing syringe, always ask your doctor, pharmacist or nurse for advice. 10. Leave the oral dispensing syringe in the bottle adapter and turn the bottle right-side up.

Place the bottle onto a flat surface. Hold the oral dispensing syringe by the barrel and carefully remove it from the adapter. Do not hold the oral dispensing syringe by the plunger, because the plunger may come out.

11. Place the tip of the oral dispensing syringe in your mouth and aim the tip toward the inside of your cheek. 12.

Gently squirt the Mercaptopurine Oral Suspension into your mouth by pushing on the plunger until the oral dispensing syringe is empty. Swallow the medicine. • Do not forcefully push on the plunger. • Do not squirt the medicine to the back of your mouth or throat. This may cause you to choke.

13. Remove the oral dispensing syringe from your mouth. 14.

Swallow the dose of oral suspension then drink some water, making sure no medicine is left in your mouth. 15. Put the cap back on the bottle with the adapter left in place.

Close the cap tightly. 16. Wash the oral dispensing syringe with warm soapy water and rinse well.

Hold the oral dispensing syringe under water and move the plunger up and down several times to make sure the inside of the oral dispensing syringe is clean. Let the oral dispensing syringe dry completely before you use it again for dosing. Do not throw away the oral dispensing syringe after use.

Ingredients in Mercaptopurine Oral Suspension Active ingredient: mercaptopurine, USP Inactive ingredients: aspartame, ethylparaben sodium, hydrochloric acid, methylparaben sodium, potassium sorbate, raspberry juice powder (raspberry juice, rice syrup solids, silicon dioxide), sodium hydroxide, sucrose, water… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 80 words ▾

PRINCIPAL DISPLAY PANEL – Bottle Carton NDC 0054- 0879 -49 100 mL per bottle Mercaptopurine Oral Suspension 2000 mg/100 mL (20 mg/mL) Shake vigorously before use for at least 30 seconds. Rx only Bottle Carton - 100 mL per bottle

PRINCIPAL DISPLAY PANEL – Bottle Label NDC 0054- 0879 -49 100 mL per bottle Mercaptopurine Oral Suspension 2000 mg/100 mL (20 mg/mL) Rx only Shake vigorously before use for at least 30 seconds. Bottle Label - 100 mL per bottle

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.
📅 Q2 2025 – Q4 2025 · 3 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
713
Units reimbursed last 4 qtrs
61.4K
Gross reimbursed last 4 qtrs
$696.4K
Avg / prescription
$976.70
Avg / unit
$11.3354
Latest quarter Q4 2025
369Rx
Fee-for-service vs managed care ⓘ
30% FFS 70% MCO
Fee-for-service · 217 Rx Managed care · 496 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 2,728 units · 34.9 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 2,600 units · 45.3 per 100k residents MN Wisconsin: 3,939 units · 66.6 per 100k residents WI Michigan: no data reported MI New York: 2,610 units · 13.3 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 1,200 units · 9.6 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: 7,300 units · 78.6 per 100k residents NJ Massachusetts: 4,118 units · 58.8 per 100k residents MA California: 10,059 units · 25.8 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 1,694 units · 27.3 per 100k residents MO Kentucky: 1,200 units · 26.5 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: 1,180 units · 108 per 100k residents RI Arizona: 5,583 units · 75.1 per 100k residents AZ New Mexico: no data reported NM Kansas: 1,400 units · 47.6 per 100k residents KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 5,833 units · 53.8 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 990 units · 21.6 per 100k residents 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: 9,000 units · 39.8 per 100k residents FL
Units reimbursed · per 100k residents
9.6108
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 Rhode Island 108 /100k
2 New Jersey 78.6 /100k
3 Arizona 75.1 /100k
4 Wisconsin 66.6 /100k
5 Massachusetts 58.8 /100k
6 North Carolina 53.8 /100k
7 Kansas 47.6 /100k
8 Minnesota 45.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Mercaptopurine — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Mercaptopurine. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.12M
Claims incl. refills
8.9K
Beneficiaries
6.5K
Spend / beneficiary
$173.07
Spend / claim
$125.65
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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 Hikma Pharmaceuticals USA Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Hikma Pharmaceuticals USA Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 00054-0843-63 · Hikma 00054-0883-25 · Hikma →
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.