Amitza is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Direct_rx. The primary component is Lubiprostone.
| Product ID | 72189-410_f2121338-9587-161d-e053-2995a90af908 |
| NDC | 72189-410 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Amitza |
| Generic Name | Lubiprostone |
| Dosage Form | Capsule, Gelatin Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2023-01-12 |
| Marketing Category | ANDA / |
| Application Number | ANDA209920 |
| Labeler Name | Direct_Rx |
| Substance Name | LUBIPROSTONE |
| Active Ingredient Strength | 8 ug/1 |
| Pharm Classes | Chloride Channel Activator [EPC], Chloride Channel Activators [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2024-12-31 |
| Marketing Start Date | 2023-01-12 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 72189-410 | Amitza | Lubiprostone |
| 35356-500 | Amitiza | lubiprostone |
| 63629-6398 | Amitiza | lubiprostone |
| 64764-080 | Amitiza | lubiprostone |
| 64764-240 | Amitiza | lubiprostone |
| 68151-5003 | Amitiza | lubiprostone |
| 0254-3028 | Lubiprostone | Lubiprostone |
| 0254-3029 | Lubiprostone | Lubiprostone |
| 0480-3479 | Lubiprostone | Lubiprostone |
| 0480-4138 | Lubiprostone | Lubiprostone |
| 10370-266 | Lubiprostone | Lubiprostone |
| 10370-267 | Lubiprostone | Lubiprostone |
| 42291-475 | Lubiprostone | Lubiprostone |
| 42291-476 | Lubiprostone | Lubiprostone |
| 43598-163 | Lubiprostone | Lubiprostone |
| 43598-168 | Lubiprostone | Lubiprostone |
| 55700-963 | Lubiprostone | Lubiprostone |
| 63304-351 | Lubiprostone | lubiprostone |
| 63304-352 | Lubiprostone | lubiprostone |
| 65162-841 | Lubiprostone | Lubiprostone |
| 65162-842 | Lubiprostone | Lubiprostone |
| 69339-162 | LUBIPROSTONE | LUBIPROSTONE |
| 69339-163 | LUBIPROSTONE | LUBIPROSTONE |