| Product NDC: | 16590-622 |
| Proprietary Name: | AMITIZA |
| Non Proprietary Name: | LUBIPROSTONE |
| Active Ingredient(s): | 8 ug/1 & nbsp; LUBIPROSTONE |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE, GELATIN COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 16590-622 |
| Labeler Name: | STAT RX USA LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021908 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20060131 |
| Package NDC: | 16590-622-30 |
| Package Description: | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (16590-622-30) |
| NDC Code | 16590-622-30 |
| Proprietary Name | AMITIZA |
| Package Description | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (16590-622-30) |
| Product NDC | 16590-622 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | LUBIPROSTONE |
| Dosage Form Name | CAPSULE, GELATIN COATED |
| Route Name | ORAL |
| Start Marketing Date | 20060131 |
| Marketing Category Name | NDA |
| Labeler Name | STAT RX USA LLC |
| Substance Name | LUBIPROSTONE |
| Strength Number | 8 |
| Strength Unit | ug/1 |
| Pharmaceutical Classes | Chloride Channel Activator [EPC],Chloride Channel Activators [MoA] |