Prescription medicine
Olsalazine Brand names: Dipentum
Olsalazine (Dipentum) is a prescription medicine with an FDA approval on record since 1990. No generic is listed; pharmacies paid $15.70 per Dipentum 250 mg capsule in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the olsalazine FDA label on DailyMed (effective May 15, 2026, Viatris Specialty LLC); the NDA 19715 record on Drugs@FDA; every olsalazine label on DailyMed.
Highlights of the record
FDA label of May 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageDIPENTUM is indicated for the maintenance of remission of ulcerative colitis in adult patients who are intolerant of sulfasalazine.
Forms and strengths
- 250 mg
Gelatin-coated capsule.
On the market
- Earliest approval on file
- July 31, 1990 Dipentum, Mylan Spclt Viatris; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $15.70 per capsule Dipentum 250 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 197 through July 30, 2026
What is olsalazine used for?
From the label: indications and usageDIPENTUM is indicated for the maintenance of remission of ulcerative colitis in adult patients who are intolerant of sulfasalazine. DIPENTUM is an aminosalicylate indicated for the maintenance of remission of ulcerative colitis in adult patients who are intolerant of sulfasalazine.
Conditions named in the indications of olsalazine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Aminosalicylate.
Source: FDA drug label (Dipentum), Viatris Specialty LLC, effective May 15, 2026 (SPL set 8512d0c6-db4e-4673-b3b4-28975c18413f), via openFDA; the full label on DailyMed
Is there a generic for olsalazine (Dipentum)?
No generic olsalazine is approved (Drugs@FDA, October 8, 2026).
- 1990 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for olsalazine (Dipentum)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $15.70 per Dipentum 250 mg capsule, up 5% from $14.95 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Dipentum 250 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dipentum 250 mg capsule | Brand | $15.70 per capsule | $470.89 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the olsalazine label say about other medicines?
The olsalazine label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name olsalazine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Azathioprine | drug interactions | Azathioprine or 6-Mercaptopurine: Increased risk of blood dyscrasias; monitor complete blood cell counts and platelet counts. |
| Heparin | drug interactions | Discontinue DIPENTUM prior to the initiation of a low molecular weight heparin or heparinoid. |
| Mercaptopurine | drug interactions | Azathioprine or 6-Mercaptopurine The concurrent use of mesalamine with azathioprine or 6‑mercaptopurine and/or any other drugs known to cause myelotoxicity (e.g., thioguanine) may increase the risk for blood disorders, bone marrow failure, and associated complications. |
| Mesalamine | drug interactions | The concurrent use of mesalamine with known nephrotoxic agents, including non‑steroidal anti‑inflammatory drugs (NSAIDs), may increase the risk of nephrotoxicity. |
| Sulfasalazine | warnings and precautions | Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to DIPENTUM or to other compounds that contain or are converted to mesalamine. |
| Thioguanine | drug interactions | Azathioprine or 6-Mercaptopurine The concurrent use of mesalamine with azathioprine or 6‑mercaptopurine and/or any other drugs known to cause myelotoxicity (e.g., thioguanine) may increase the risk for blood disorders, bone marrow failure, and associated complications. |
Source: FDA drug label (Dipentum), Viatris Specialty LLC, effective May 15, 2026 (SPL set 8512d0c6-db4e-4673-b3b4-28975c18413f), via openFDA; the full label on DailyMed
What do FAERS reports show for olsalazine?
The FDA Adverse Event Reporting System holds 197 reports that list olsalazine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11 are coded as a death and 69 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as olsalazine?
4 other medicines are given the same way (oral) and in the same FDA class as olsalazine or labeled mainly for the same use (crohn's disease and ulcerative colitis), the same class first. Crohn's disease and ulcerative colitis lists all 29 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Mesalamine | Crohn's disease and ulcerative colitis | 27 labelers | $0.781 per tablet 1.2 g tablet | A presentation being discontinued |
| Sulfasalazine | Crohn's disease and ulcerative colitis | 5 labelers | $0.199 per tablet 500 mg tablet | No current entry |
| Balsalazide | Crohn's disease and ulcerative colitis | 9 labelers | $0.344 per capsule 750 mg capsule | No current entry |
| Etrasimod arginine | Crohn's disease and ulcerative colitis | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as olsalazine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to olsalazine
- 4 medicines for the same use
- Other aminosalicylates
- the pharmacologic class, with prices and generics
- Olsalazine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other