PillLubiprostone
Brands: Amitiza · Amitza · Lubiprostone
12 active makers
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US acquisition costNADAC · per unit
Average across 15 priced NDCs. A benchmark of pharmacy acquisition cost — not a retail quote.
Medicaid dispensing volumeSDUD · per quarter
Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.
Who makes it12 active · 2 exited
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Proficient Rx LP | unknown | 33 | SUPPLYING |
| Asclemed USA, Inc. | unknown | 8 | SUPPLYING |
| SpecGx LLC | unknown | 4 | SUPPLYING |
| Par Health USA, LLC | unknown | 2 | SUPPLYING |
| Golden State Medical Supply, Inc. | unknown | 2 | SUPPLYING |
| American Health Packaging | unknown | 2 | SUPPLYING |
| Teva Pharmaceuticals USA, Inc. | unknown | 2 | SUPPLYING |
| Advanced Rx of Tennessee, LLC | unknown | 2 | SUPPLYING |
| Natco Pharma Limited | unknown | 2 | SUPPLYING |
| Direct_Rx | unknown | 2 | SUPPLYING |
| Dr.Reddy's laboratories Limited | unknown | 2 | SUPPLYING |
| SUN PHARMACEUTICAL INDUSTRIES, INC. | unknown | 2 | SUPPLYING |
| Quality Care Products, LLC | unknown | 1 | EXITED 2026 |
| Takeda Pharmaceuticals America, Inc. | unknown | 1 | EXITED 2027 |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- May 13, 2019RECALLRecall (Class II): Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64…
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. — Recalling firm: MALLINCKRODT PHARMACEUTICALS — US Nationwide
- May 13, 2019RECALLRecall (Class II): Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 6…
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. — Recalling firm: MALLINCKRODT PHARMACEUTICALS — US Nationwide
- Nov 6, 2018RECALLRecall (Class III): AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville M…
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing. — Recalling firm: Takeda Development Center Americas, Inc. — Product was distributed to 32 distributors throughout the United States.