| Product NDC: | 0172-4364 |
| Proprietary Name: | Labetalol Hydrochloride |
| Non Proprietary Name: | Labetalol Hydrochloride |
| Active Ingredient(s): | 100 mg/1 & nbsp; Labetalol Hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0172-4364 |
| Labeler Name: | IVAX Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA074787 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 19980803 |
| Package NDC: | 0172-4364-10 |
| Package Description: | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0172-4364-10) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0172-4364-00) |
| NDC Code | 0172-4364-10 |
| Proprietary Name | Labetalol Hydrochloride |
| Package Description | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0172-4364-10) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0172-4364-00) |
| Product NDC | 0172-4364 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Labetalol Hydrochloride |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 19980803 |
| Marketing Category Name | ANDA |
| Labeler Name | IVAX Pharmaceuticals, Inc. |
| Substance Name | LABETALOL HYDROCHLORIDE |
| Strength Number | 100 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] |