| Product NDC: | 0065-0325 |
| Proprietary Name: | EMADINE |
| Non Proprietary Name: | EMEDASTINE DIFUMARATE |
| Active Ingredient(s): | .884 mg/mL & nbsp; EMEDASTINE DIFUMARATE |
| Administration Route(s): | OPHTHALMIC |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0065-0325 |
| Labeler Name: | Alcon Laboratories, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020706 |
| Marketing Category: | NDA |
| Start Marketing Date: | 19980215 |
| Package NDC: | 0065-0325-05 |
| Package Description: | 5 mL in 1 BOTTLE, PLASTIC (0065-0325-05) |
| NDC Code | 0065-0325-05 |
| Proprietary Name | EMADINE |
| Package Description | 5 mL in 1 BOTTLE, PLASTIC (0065-0325-05) |
| Product NDC | 0065-0325 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | EMEDASTINE DIFUMARATE |
| Dosage Form Name | SOLUTION |
| Route Name | OPHTHALMIC |
| Start Marketing Date | 19980215 |
| Marketing Category Name | NDA |
| Labeler Name | Alcon Laboratories, Inc. |
| Substance Name | EMEDASTINE DIFUMARATE |
| Strength Number | .884 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] |