| Product NDC: | 65649-802 |
| Proprietary Name: | FULYZAQ |
| Non Proprietary Name: | Crofelemer |
| Active Ingredient(s): | 125 mg/1 & nbsp; Crofelemer |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 65649-802 |
| Labeler Name: | Salix Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA202292 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20121231 |
| Package NDC: | 65649-802-02 |
| Package Description: | 60 TABLET, COATED in 1 BOTTLE (65649-802-02) |
| NDC Code | 65649-802-02 |
| Proprietary Name | FULYZAQ |
| Package Description | 60 TABLET, COATED in 1 BOTTLE (65649-802-02) |
| Product NDC | 65649-802 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Crofelemer |
| Dosage Form Name | TABLET, COATED |
| Route Name | ORAL |
| Start Marketing Date | 20121231 |
| Marketing Category Name | NDA |
| Labeler Name | Salix Pharmaceuticals, Inc. |
| Substance Name | CROFELEMER |
| Strength Number | 125 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes |