| Product NDC: | 30698-911 |
| Proprietary Name: | Rocaltrol |
| Non Proprietary Name: | calcitriol |
| Active Ingredient(s): | 1 ug/mL & nbsp; calcitriol |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 30698-911 |
| Labeler Name: | Validus Pharmaceuticals LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021068 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090723 |
| Package NDC: | 30698-911-15 |
| Package Description: | 15 mL in 1 BOTTLE (30698-911-15) |
| NDC Code | 30698-911-15 |
| Proprietary Name | Rocaltrol |
| Package Description | 15 mL in 1 BOTTLE (30698-911-15) |
| Product NDC | 30698-911 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | calcitriol |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 20090723 |
| Marketing Category Name | NDA |
| Labeler Name | Validus Pharmaceuticals LLC |
| Substance Name | CALCITRIOL |
| Strength Number | 1 |
| Strength Unit | ug/mL |
| Pharmaceutical Classes | Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] |