| Product NDC: | 49884-124 | 
| Proprietary Name: | Labetalol HCL | 
| Non Proprietary Name: | Labetalol Hydrochloride | 
| Active Ingredient(s): | 300 mg/1 & nbsp; Labetalol Hydrochloride | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | TABLET, FILM COATED | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 49884-124 | 
| Labeler Name: | Par Pharmaceutical Companies, Inc. | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | ANDA200908 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20120724 | 
| Package NDC: | 49884-124-10 | 
| Package Description: | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49884-124-10) | 
| NDC Code | 49884-124-10 | 
| Proprietary Name | Labetalol HCL | 
| Package Description | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49884-124-10) | 
| Product NDC | 49884-124 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | Labetalol Hydrochloride | 
| Dosage Form Name | TABLET, FILM COATED | 
| Route Name | ORAL | 
| Start Marketing Date | 20120724 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Par Pharmaceutical Companies, Inc. | 
| Substance Name | LABETALOL HYDROCHLORIDE | 
| Strength Number | 300 | 
| Strength Unit | mg/1 | 
| Pharmaceutical Classes | Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] |