| Product NDC: | 0054-8722 |
| Proprietary Name: | PredniSONE |
| Non Proprietary Name: | PredniSONE |
| Active Ingredient(s): | 5 mg/mL & nbsp; PredniSONE |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0054-8722 |
| Labeler Name: | Roxane Laboratories, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA088703 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 19861213 |
| Package NDC: | 0054-8722-16 |
| Package Description: | 10 CUP, UNIT-DOSE in 1 CONTAINER (0054-8722-16) > 5 mL in 1 CUP, UNIT-DOSE |
| NDC Code | 0054-8722-16 |
| Proprietary Name | PredniSONE |
| Package Description | 10 CUP, UNIT-DOSE in 1 CONTAINER (0054-8722-16) > 5 mL in 1 CUP, UNIT-DOSE |
| Product NDC | 0054-8722 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | PredniSONE |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 19861213 |
| Marketing Category Name | ANDA |
| Labeler Name | Roxane Laboratories, Inc. |
| Substance Name | PREDNISONE |
| Strength Number | 5 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes |