Quick answers
- What is Lubiprostone used for?
- The FDA-approved label (Amitiza, SpecGx LLC, July 10, 2026) says: “Amitiza is a chloride channel activator indicated for the treatment of: chronic idiopathic constipation (CIC) in adults. opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. Limitations of Use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lubiprostone have a boxed warning?
- No. None of the 25 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Lubiprostone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Lubiprostone been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started May 13, 2019 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Lubiprostone?
- 18 companies list prescription products of Lubiprostone in the FDA NDC Directory, including Proficient Rx LP, SpecGx LLC and Asclemed USA, Inc..
What Lubiprostone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Amitiza is a chloride channel activator indicated for the treatment of: chronic idiopathic constipation (CIC) in adults. opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. Limitations of Use …
— FDA label: Amitiza, SpecGx LLC, effective July 10, 2026. Read the full label on DailyMed →
The FDA has 25 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 25 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 |
|---|---|---|
| lubiprostone 0.008 mg capsule | Generic | $0.5674 per capsule |
| lubiprostone 0.024 mg capsule | Generic | $0.6456 per capsule |
| lubiprostone 24 ug capsule | Generic | $0.6456 per capsule |
| lubiprostone 24 ug capsule, gelatin coated | Generic | $0.6456 per capsule |
| lubiprostone 24 ug capsule, gelatin coated | Brand: Amitiza | $6.45 per capsule |
| lubiprostone 8 ug capsule | Generic | $0.5674 per capsule |
| lubiprostone 8 ug capsule, gelatin coated | Generic | $0.5674 per capsule |
| lubiprostone 8 ug capsule, gelatin coated | Brand: Amitiza | $6.47 per capsule |
NADAC list of November 4, 2026; these prices took effect between April 22, 2026 and 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.
- Proficient Rx LP5 products
- SpecGx LLC4 products
- Asclemed USA, Inc.4 products
- Dr. Reddy's Laboratories Inc.2 products
- NorthStar Rx LLC2 products
- Direct_Rx2 products
- Camber Pharmaceuticals, Inc.2 products
- Sun Pharmaceutical Industries, Inc.2 products
- Natco Pharma USA LLC2 products
- Takeda Pharmaceuticals America, Inc.2 products
- Amneal Pharmaceuticals LLC2 products
- Advanced Rx of Tennessee, LLC2 products
- Zydus Pharmaceuticals USA Inc.2 products
- Teva Pharmaceuticals, Inc.2 products
- Golden State Medical Supply, Inc.2 products
- American Health Packaging2 products
- Par Health USA, LLC2 products
- Zydus Lifesciences Limited2 products
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 |
|---|---|---|---|
| NDA021908 AMITIZA | Sucampo Pharma LLC | January 31, 2006 | 10, latest November 30, 2020 2020: Labeling · 2018: Efficacy · 2017: Labeling |
Generic approvals (4)
- ANDA209450Amneal · November 30, 2021
- ANDA209920Teva Pharms USA Inc · January 18, 2022
- ANDA214131Zydus Pharms · March 23, 2023
- ANDA218640Ascent Pharms Inc · January 2, 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.
-
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.
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) | 616578, 617768, 794639, 794641 |
|---|---|
| SPL set ID of the quoted label | 164a2b47-0a52-4bb4-9e71-5342c2e951f4 |
| FDA labels (SPL) | 25 |
| FDA applications | NDA021908, 4 ANDA |
| Active ingredients (FDA) | LUBIPROSTONE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Amitiza, SpecGx LLC, effective July 10, 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 →