Betapace

Product NDC
13672-052
11-digit product format
136720052
Labeler code
13672
Product ID
13672-052_d723021a-3258-876b-e053-2995a90a3e77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sotalol HCl
Dosage form
TABLET
Route
ORAL
Labeler
Skyepharma Production SAS
Application
NDA019865
Marketing category
NDA
Marketing start
1992-10-30
Marketing end
0000-00-00
Substance
SOTALOL HYDROCHLORIDE
Active strength
120 mg/120mg
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13672-052-0013672005200100 mg in 1 BOTTLE (13672-052-00) 100 mg1992-10-300000-00-00NoNoCurrent