| Product NDC: | 0065-0638 |
| Proprietary Name: | OMNIPRED |
| Non Proprietary Name: | prednisolone acetate |
| Active Ingredient(s): | 10 mg/mL & nbsp; prednisolone acetate |
| Administration Route(s): | OPHTHALMIC |
| Dosage Form(s): | SUSPENSION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0065-0638 |
| Labeler Name: | Alcon Laboratories, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA017469 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20071106 |
| Package NDC: | 0065-0638-27 |
| Package Description: | 5 mL in 1 BOTTLE, PLASTIC (0065-0638-27) |
| NDC Code | 0065-0638-27 |
| Proprietary Name | OMNIPRED |
| Package Description | 5 mL in 1 BOTTLE, PLASTIC (0065-0638-27) |
| Product NDC | 0065-0638 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | prednisolone acetate |
| Dosage Form Name | SUSPENSION |
| Route Name | OPHTHALMIC |
| Start Marketing Date | 20071106 |
| Marketing Category Name | NDA |
| Labeler Name | Alcon Laboratories, Inc. |
| Substance Name | PREDNISOLONE ACETATE |
| Strength Number | 10 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |