Sotalol Hydrochloride

Product NDC
0378-5124
11-digit product format
003785124
Labeler code
0378
Product ID
0378-5124_3f4eac4d-6f01-4e6a-8144-65448519efdb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sotalol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA077616
Marketing category
ANDA
Marketing start
2007-02-20
Marketing end
0000-00-00
Substance
SOTALOL HYDROCHLORIDE
Active strength
120 mg/1
Pharmacologic classes
Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-5124-01EA - Each0378-512433cbda4d-84e2-461f-b9e4-8e17e0ecd9a612012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-5124-0100378512401100 TABLET in 1 BOTTLE, PLASTIC (0378-5124-01) 100 tablet2007-02-200000-00-00NoNoCurrent