Brands: Amitiza · Amitza · Lubiprostone
Average across 15 priced NDCs. A benchmark of pharmacy acquisition cost - not a retail quote.
Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume - Medicaid only, not all-payer.
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 | repackager | 34 | SUPPLYING |
| Asclemed USA, Inc. | repackager | 8 | SUPPLYING |
| SpecGx LLC | unknown | 4 | SUPPLYING |
| Par Health USA, LLC | unknown | 2 | SUPPLYING |
| Golden State Medical Supply, Inc. | repackager | 2 | SUPPLYING |
| American Health Packaging | repackager | 2 | SUPPLYING |
| Teva Pharmaceuticals USA, Inc. | generic | 2 | SUPPLYING |
| Advanced Rx of Tennessee, LLC | repackager | 2 | SUPPLYING |
| Natco Pharma Limited | unknown | 2 | SUPPLYING |
| Direct_Rx | repackager | 2 | SUPPLYING |
| Dr.Reddy's laboratories Limited | unknown | 2 | SUPPLYING |
| SUN PHARMACEUTICAL INDUSTRIES, INC. | generic | 2 | SUPPLYING |
| Quality Care Products, LLC | repackager | 1 | EXITED 2026 |
| Takeda Pharmaceuticals America, Inc. | unknown | 1 | EXITED 2027 |
Shortages, recalls, and registration changes attached to this drug concept.
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
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
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.
