Product NDC: | 65483-391 |
Proprietary Name: | Trandate |
Non Proprietary Name: | labetalol hydrochloride |
Active Ingredient(s): | 100 mg/1 & nbsp; labetalol hydrochloride |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 65483-391 |
Labeler Name: | Prometheus Laboratories Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA018716 |
Marketing Category: | NDA |
Start Marketing Date: | 19840531 |
Package NDC: | 65483-391-10 |
Package Description: | 100 TABLET in 1 BOTTLE (65483-391-10) |
NDC Code | 65483-391-10 |
Proprietary Name | Trandate |
Package Description | 100 TABLET in 1 BOTTLE (65483-391-10) |
Product NDC | 65483-391 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | labetalol hydrochloride |
Dosage Form Name | TABLET |
Route Name | ORAL |
Start Marketing Date | 19840531 |
Marketing Category Name | NDA |
Labeler Name | Prometheus Laboratories Inc. |
Substance Name | LABETALOL HYDROCHLORIDE |
Strength Number | 100 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] |