| Product NDC: | 54868-4278 |
| Proprietary Name: | LOTEMAX |
| Non Proprietary Name: | loteprednol etabonate |
| Active Ingredient(s): | 5 mg/mL & nbsp; loteprednol etabonate |
| Administration Route(s): | OPHTHALMIC |
| Dosage Form(s): | SUSPENSION/ DROPS |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 54868-4278 |
| Labeler Name: | Physicians Total Care, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020583 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20021017 |
| Package NDC: | 54868-4278-1 |
| Package Description: | 1 BOTTLE in 1 CARTON (54868-4278-1) > 5 mL in 1 BOTTLE |
| NDC Code | 54868-4278-1 |
| Proprietary Name | LOTEMAX |
| Package Description | 1 BOTTLE in 1 CARTON (54868-4278-1) > 5 mL in 1 BOTTLE |
| Product NDC | 54868-4278 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | loteprednol etabonate |
| Dosage Form Name | SUSPENSION/ DROPS |
| Route Name | OPHTHALMIC |
| Start Marketing Date | 20021017 |
| Marketing Category Name | NDA |
| Labeler Name | Physicians Total Care, Inc. |
| Substance Name | LOTEPREDNOL ETABONATE |
| Strength Number | 5 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes |