| Product NDC: | 52959-265 |
| Proprietary Name: | PREDNISOLONE ACETATE |
| Non Proprietary Name: | prednisolone acetate |
| Active Ingredient(s): | 10 mg/mL & nbsp; prednisolone acetate |
| Administration Route(s): | OPHTHALMIC |
| Dosage Form(s): | SUSPENSION/ DROPS |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 52959-265 |
| Labeler Name: | H.J. Harkins Company, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA017011 |
| Marketing Category: | NDA AUTHORIZED GENERIC |
| Start Marketing Date: | 19970819 |
| Package NDC: | 52959-265-05 |
| Package Description: | 5 mL in 1 BOTTLE, DROPPER (52959-265-05) |
| NDC Code | 52959-265-05 |
| Proprietary Name | PREDNISOLONE ACETATE |
| Package Description | 5 mL in 1 BOTTLE, DROPPER (52959-265-05) |
| Product NDC | 52959-265 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | prednisolone acetate |
| Dosage Form Name | SUSPENSION/ DROPS |
| Route Name | OPHTHALMIC |
| Start Marketing Date | 19970819 |
| Marketing Category Name | NDA AUTHORIZED GENERIC |
| Labeler Name | H.J. Harkins Company, Inc. |
| Substance Name | PREDNISOLONE ACETATE |
| Strength Number | 10 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |