Quick answers
- What is Pentasa?
- Pentasa is a brand name of Mesalamine, a prescription medicine. The FDA NDC Directory lists 2 Pentasa products in 2 strengths and forms.
- Who makes Pentasa?
- Takeda Pharms USA holds the FDA application for Pentasa (NDA020049, approved May 10, 1993).
- Is there a generic or store brand of Pentasa?
- Other products of Mesalamine are listed with the FDA, but none in exactly the same strength and form as a Pentasa product.
- What do pharmacies pay for Pentasa?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 2 Pentasa strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Pentasa been recalled?
- FDA enforcement reports list 1 recall of Pentasa products; the newest started December 2, 2016. A recall usually concerns specific lots, not every product.
What Pentasa is
Each Pentasa product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Mesalamine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| mesalamine 250 mg capsule (oral) | Pentasa | None listed | — |
| mesalamine 500 mg capsule (oral) | Pentasa | None listed | — |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Mesalamine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA020049 | Takeda Pharms USA | May 10, 1993 | 2 |
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 |
|---|---|---|
| mesalamine 250 mg capsule | Brand: Pentasa | $2.90 per capsule |
| mesalamine 500 mg capsule | Brand: Pentasa | $5.82 per capsule |
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 Pentasa
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Pentasa products.
- Takeda Pharmaceuticals America, Inc.2 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
December 2, 2016 · Class III · Terminated · D-0432-2017
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81 — Shire PLC
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.