| Product NDC: | 42806-038 | 
| Proprietary Name: | Betaxolol | 
| Non Proprietary Name: | Betaxolol | 
| Active Ingredient(s): | 10 mg/1 & nbsp; Betaxolol | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | TABLET, FILM COATED | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 42806-038 | 
| Labeler Name: | Epic Pharma LLC | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | ANDA075541 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20100720 | 
| Package NDC: | 42806-038-10 | 
| Package Description: | 1000 TABLET, FILM COATED in 1 BOTTLE (42806-038-10) | 
| NDC Code | 42806-038-10 | 
| Proprietary Name | Betaxolol | 
| Package Description | 1000 TABLET, FILM COATED in 1 BOTTLE (42806-038-10) | 
| Product NDC | 42806-038 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | Betaxolol | 
| Dosage Form Name | TABLET, FILM COATED | 
| Route Name | ORAL | 
| Start Marketing Date | 20100720 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Epic Pharma LLC | 
| Substance Name | BETAXOLOL HYDROCHLORIDE | 
| Strength Number | 10 | 
| Strength Unit | mg/1 | 
| Pharmaceutical Classes | Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] |