Sotalol Hydrochloride

Product NDC
63187-426
11-digit product format
631870426
Labeler code
63187
Product ID
63187-426_32166c61-51dc-436c-8d05-08265dc33276
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075563
Marketing category
ANDA
Marketing start
2003-11-07
Marketing end
0000-00-00
Substance
SOTALOL HYDROCHLORIDE
Active strength
80 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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SOTALOL HYDROCHLORIDEACTIVE INGREDIENTHEC37C70XXSOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
SOTALOLACTIVE MOIETYA6D97U294ISOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-426SOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP]3Legacy NDC20191121_03de4b65-29b0-4e30-a94b-b5877a050f93.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-426-306318704263030 TABLET in 1 BOTTLE, PLASTIC (63187-426-30) 30 tablet2015-02-020000-00-00NoNoCurrent
63187-426-606318704266060 TABLET in 1 BOTTLE, PLASTIC (63187-426-60) 60 tablet2015-02-020000-00-00NoNoCurrent
63187-426-906318704269090 TABLET in 1 BOTTLE, PLASTIC (63187-426-90) 90 tablet2015-02-020000-00-00NoNoCurrent