| Product NDC: | 0054-3721 | 
| Proprietary Name: | PredniSONE Intensol | 
| Non Proprietary Name: | PredniSONE Intensol | 
| Active Ingredient(s): | 5 mg/mL & nbsp; PredniSONE Intensol | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | SOLUTION, CONCENTRATE | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 0054-3721 | 
| Labeler Name: | Roxane Laboratories, Inc. | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | ANDA088810 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 19850220 | 
| Package NDC: | 0054-3721-44 | 
| Package Description: | 30 mL in 1 BOTTLE, DROPPER (0054-3721-44) | 
| NDC Code | 0054-3721-44 | 
| Proprietary Name | PredniSONE Intensol | 
| Package Description | 30 mL in 1 BOTTLE, DROPPER (0054-3721-44) | 
| Product NDC | 0054-3721 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | PredniSONE Intensol | 
| Dosage Form Name | SOLUTION, CONCENTRATE | 
| Route Name | ORAL | 
| Start Marketing Date | 19850220 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Roxane Laboratories, Inc. | 
| Substance Name | PREDNISONE | 
| Strength Number | 5 | 
| Strength Unit | mg/mL | 
| Pharmaceutical Classes |