Quick answers
- What is Azathioprine used for?
- The FDA-approved label (Imuran, Sebela Pharmaceuticals Inc., November 8, 2025) says: “IMURAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms. Renal Homotransplantation: IMURAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Azathioprine have a boxed warning?
- Yes. The FDA label for Imuran has a boxed warning (“WARNING - MALIGNANCY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Azathioprine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Azathioprine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Azathioprine?
- 18 companies list prescription products of Azathioprine in the FDA NDC Directory, including Ascend Laboratories, LLC, Amneal Pharmaceuticals NY LLC and Zydus Lifesciences Limited.
What Azathioprine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
IMURAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms. Renal Homotransplantation: IMURAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. …
— FDA label: Imuran, Sebela Pharmaceuticals Inc., effective November 8, 2025. Read the full label on DailyMed →
The FDA has 19 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.
This label has a boxed warning. Its heading: WARNING - MALIGNANCY
. Read it on the full label →
17 of 19 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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 |
|---|---|---|
| azathioprine 100 mg tablet | Generic | $3.44 per tablet |
| azathioprine 50 mg tablet | Generic | $0.1282 per tablet |
| azathioprine 75 mg tablet | Generic | $6.90 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.
- Ascend Laboratories, LLC4 products
- Amneal Pharmaceuticals NY LLC4 products
- Zydus Lifesciences Limited4 products
- Zydus Pharmaceuticals USA Inc.4 products
- AvKARE2 products
- NuCare Pharmaceuticals, Inc.2 products
- Salix Pharmaceuticals2 products
- Oceanside Pharmaceuticals2 products
- Golden State Medical Supply, Inc.1 product
- Legacy Pharma USA Inc.1 product
- Glenmark Pharmaceuticals Inc1 product
- Rising Pharma Holdings, Inc.1 product
- American Health Packaging1 product
- Remedyrepack Inc.1 product
- Aphena Pharma Solutions - Tennessee, LLC1 product
- PD-Rx Pharmaceuticals, Inc.1 product
- Sebela Pharmaceuticals Inc.1 product
- Hikma Pharmaceuticals USA Inc.1 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 |
|---|---|---|---|
| NDA016324 IMURAN | Legacy | March 20, 1968 | 21, latest July 9, 2024 2024: Labeling · 2018: Labeling · 2017: Manufacturing (CMC) |
Generic approvals (6)
- ANDA074419Hikma · March 31, 1995
- ANDA074069Amneal · February 16, 1996
- ANDA075252Aaipharma LLC · June 7, 1999
- ANDA075568Rising · December 13, 1999
- ANDA077621Zydus Pharms USA · March 15, 2007
- ANDA208687Alkem Labs Ltd · March 27, 2020
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Imuran, Sebela Pharmaceuticals Inc., effective November 8, 2025; 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 →