Trandate - 65483-391-10 - (labetalol hydrochloride)

Alphabetical Index


Drug Information of Trandate

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)

Labeler Information of Trandate

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 Information of Trandate

Package NDC: 65483-391-10
Package Description: 100 TABLET in 1 BOTTLE (65483-391-10)

NDC Information of Trandate

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]

Complete Information of Trandate


General Information