| Product NDC: | 0054-3120 |
| Proprietary Name: | Calcitriol |
| 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: | 0054-3120 |
| Labeler Name: | Roxane Laboratories, Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA076242 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20030718 |
| Package NDC: | 0054-3120-41 |
| Package Description: | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0054-3120-41) > 15 mL in 1 BOTTLE, WITH APPLICATOR |
| NDC Code | 0054-3120-41 |
| Proprietary Name | Calcitriol |
| Package Description | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0054-3120-41) > 15 mL in 1 BOTTLE, WITH APPLICATOR |
| Product NDC | 0054-3120 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Calcitriol |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 20030718 |
| Marketing Category Name | ANDA |
| Labeler Name | Roxane Laboratories, Inc |
| Substance Name | CALCITRIOL |
| Strength Number | 1 |
| Strength Unit | ug/mL |
| Pharmaceutical Classes | Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] |