Product NDC: | 54868-5971 |
Proprietary Name: | Amitiza |
Non Proprietary Name: | lubiprostone |
Active Ingredient(s): | 24 ug/1 & nbsp; lubiprostone |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE, GELATIN COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 54868-5971 |
Labeler Name: | Physicians Total Care, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021908 |
Marketing Category: | NDA |
Start Marketing Date: | 20081216 |
Package NDC: | 54868-5971-0 |
Package Description: | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (54868-5971-0) |
NDC Code | 54868-5971-0 |
Proprietary Name | Amitiza |
Package Description | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (54868-5971-0) |
Product NDC | 54868-5971 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | lubiprostone |
Dosage Form Name | CAPSULE, GELATIN COATED |
Route Name | ORAL |
Start Marketing Date | 20081216 |
Marketing Category Name | NDA |
Labeler Name | Physicians Total Care, Inc. |
Substance Name | LUBIPROSTONE |
Strength Number | 24 |
Strength Unit | ug/1 |
Pharmaceutical Classes | Chloride Channel Activator [EPC],Chloride Channel Activators [MoA] |