Betapace - 50419-109-10 - (Sotalol Hydrochloride)

Alphabetical Index


Drug Information of Betapace

Product NDC: 50419-109
Proprietary Name: Betapace
Non Proprietary Name: Sotalol Hydrochloride
Active Ingredient(s): 120    mg/1 & nbsp;   Sotalol Hydrochloride
Administration Route(s): ORAL
Dosage Form(s): TABLET
Coding System: National Drug Codes(NDC)

Labeler Information of Betapace

Product NDC: 50419-109
Labeler Name: Bayer HealthCare Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA019865
Marketing Category: NDA
Start Marketing Date: 19921030

Package Information of Betapace

Package NDC: 50419-109-10
Package Description: 100 TABLET in 1 BOTTLE (50419-109-10)

NDC Information of Betapace

NDC Code 50419-109-10
Proprietary Name Betapace
Package Description 100 TABLET in 1 BOTTLE (50419-109-10)
Product NDC 50419-109
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Sotalol Hydrochloride
Dosage Form Name TABLET
Route Name ORAL
Start Marketing Date 19921030
Marketing Category Name NDA
Labeler Name Bayer HealthCare Pharmaceuticals Inc.
Substance Name SOTALOL HYDROCHLORIDE
Strength Number 120
Strength Unit mg/1
Pharmaceutical Classes Antiarrhythmic [EPC]

Complete Information of Betapace


General Information