| Product NDC: | 67425-007 |
| Proprietary Name: | BEPREVE |
| Non Proprietary Name: | bepotastine besilate |
| Active Ingredient(s): | 15 mg/mL & nbsp; bepotastine besilate |
| Administration Route(s): | OPHTHALMIC |
| Dosage Form(s): | SOLUTION/ DROPS |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 67425-007 |
| Labeler Name: | Ista Pharmaceuticals, Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022288 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090908 |
| Package NDC: | 67425-007-12 |
| Package Description: | 1 BOTTLE, DROPPER in 1 CARTON (67425-007-12) > 2.5 mL in 1 BOTTLE, DROPPER |
| NDC Code | 67425-007-12 |
| Proprietary Name | BEPREVE |
| Package Description | 1 BOTTLE, DROPPER in 1 CARTON (67425-007-12) > 2.5 mL in 1 BOTTLE, DROPPER |
| Product NDC | 67425-007 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | bepotastine besilate |
| Dosage Form Name | SOLUTION/ DROPS |
| Route Name | OPHTHALMIC |
| Start Marketing Date | 20090908 |
| Marketing Category Name | NDA |
| Labeler Name | Ista Pharmaceuticals, Inc |
| Substance Name | BEPOTASTINE BESILATE |
| Strength Number | 15 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Histamine-1 Receptor Antagonist [EPC] |