| Product NDC: | 68875-0101 |
| Proprietary Name: | Gattex |
| Non Proprietary Name: | teduglutide |
| Active Ingredient(s): | 5 mg/1 & nbsp; teduglutide |
| Administration Route(s): | SUBCUTANEOUS |
| Dosage Form(s): | INJECTION, POWDER, FOR SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 68875-0101 |
| Labeler Name: | NPS Pharmaceuticals |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA203441 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20121221 |
| Package NDC: | 68875-0101-2 |
| Package Description: | 30 VIAL in 1 CARTON (68875-0101-2) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (68875-0101-1) |
| NDC Code | 68875-0101-2 |
| Proprietary Name | Gattex |
| Package Description | 30 VIAL in 1 CARTON (68875-0101-2) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (68875-0101-1) |
| Product NDC | 68875-0101 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | teduglutide |
| Dosage Form Name | INJECTION, POWDER, FOR SOLUTION |
| Route Name | SUBCUTANEOUS |
| Start Marketing Date | 20121221 |
| Marketing Category Name | NDA |
| Labeler Name | NPS Pharmaceuticals |
| Substance Name | TEDUGLUTIDE |
| Strength Number | 5 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes |