Quick answers
- What is Mercaptopurine used for?
- The FDA-approved label (Mercaptopurine, Nova Laboratories, Ltd, July 20, 2026) says: “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 Acute Lymphoblastic Leukemia MERCAPTOPURINE is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Mercaptopurine have a boxed warning?
- No. None of the 7 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Mercaptopurine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Mercaptopurine been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started April 4, 2014 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Mercaptopurine?
- 4 companies list prescription products of Mercaptopurine in the FDA NDC Directory, including Hikma Pharmaceuticals USA Inc., Nova Laboratories, Ltd and Golden State Medical Supply, Inc..
What Mercaptopurine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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 Acute Lymphoblastic Leukemia MERCAPTOPURINE is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
— FDA label: Mercaptopurine, Nova Laboratories, Ltd, effective July 20, 2026. Read the full label on DailyMed →
The FDA has 7 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Suspension · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 7 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| mercaptopurine 50 mg tablet | Generic | $1.04 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Hikma Pharmaceuticals USA Inc.3 products
- Nova Laboratories, Ltd2 products
- Golden State Medical Supply, Inc.1 product
- Florida Pharmaceutical Products, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA009053 PURINETHOL | Stason Pharms | September 11, 1953 | 21, latest July 9, 2024 2024: Labeling · 2020: Labeling · 2020: Labeling |
| NDA205919 PURIXAN | Nova Labs Ltd | April 28, 2014 | 7, latest July 16, 2026 2026: Labeling · 2024: Labeling · 2024: Labeling |
Generic approvals (2)
- ANDA040528Hikma · February 13, 2004
- ANDA216418Hikma · February 26, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 4, 2014 · Class III · Terminated · D-1314-2014
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.
Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11 — Boehringer Ingelheim Roxane Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 197931, 1536484, 1536490 |
|---|---|
| SPL set ID of the quoted label | 9c6fc66b-522f-499d-961a-cde6ca0ec2e5 |
| FDA labels (SPL) | 7 |
| FDA applications | NDA009053, NDA205919, 2 ANDA |
| Active ingredients (FDA) | MERCAPTOPURINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Mercaptopurine, Nova Laboratories, Ltd, effective July 20, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →