Quick answers
- What is Amitiza?
- Amitiza is a brand name of Lubiprostone, a prescription medicine. The FDA NDC Directory lists 4 Amitiza products in 2 strengths and forms.
- Who makes Amitiza?
- Sucampo Pharma LLC holds the FDA application for Amitiza (NDA021908, approved January 31, 2006). 1 other company (repackagers or distributors) also list Amitiza products.
- Is there a generic or store brand of Amitiza?
- Yes. The FDA NDC Directory lists 27 other products with the same active ingredients, strength and form as a Amitiza product, 27 of them generic. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Amitiza?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 2 Amitiza 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 Amitiza been recalled?
- FDA enforcement reports list 3 recalls of Amitiza products; the newest started May 13, 2019. A recall usually concerns specific lots, not every product.
What Amitiza is
Each Amitiza 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.
Lubiprostone · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| lubiprostone 24 ug capsule, gelatin coated (oral) | Amitiza | 15 products, 12 companies | DailyMed |
| lubiprostone 8 ug capsule, gelatin coated (oral) | Amitiza | 12 products, 12 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Lubiprostone →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA021908 | Sucampo Pharma LLC | January 31, 2006 | 4 |
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 |
|---|---|---|
| lubiprostone 24 ug capsule, gelatin coated | Brand: Amitiza | $6.45 per capsule Generic of the same strength and form: $0.6456 per capsule |
| lubiprostone 8 ug capsule, gelatin coated | Brand: Amitiza | $6.47 per capsule Generic of the same strength and form: $0.5674 per capsule |
NADAC list of November 4, 2026; these prices took effect on April 22, 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 Amitiza
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Amitiza products.
- Takeda Pharmaceuticals America, Inc.2 products
- SpecGx LLC2 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.
-
May 13, 2019 · Class II · Terminated · D-1295-2019
Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-240-60 — MALLINCKRODT PHARMACEUTICALS
-
May 13, 2019 · Class II · Terminated · D-1294-2019
Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60 — MALLINCKRODT PHARMACEUTICALS
-
November 6, 2018 · Class III · Terminated · D-0286-2019
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville MD 20850 and Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Active Ingredient made in Japan — Takeda Development Center Americas, Inc.
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.