Sotalol

Product NDC
72162-2523
11-digit product format
721622523
Labeler code
72162
Product ID
72162-2523_ccf71ac1-c65a-4da7-ad32-c685615c900b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207428
Marketing category
ANDA
Marketing start
2017-12-06
Substance
SOTALOL HYDROCHLORIDE
Active strength
160 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sotalol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOTALOL HYDROCHLORIDE160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHEC37C70XX
Rxcui1923424

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83083289-08f8-450a-8eff-9d912bdd64bbProduct name120200505
8b3790df-333b-074c-6570-5beaa3352b77Product name220190213
424d69b0-0855-4fff-846d-7ced5f554385Product name120150403
9ab69b37-6a2f-6dca-a9fd-3131946f16f2Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2523-1Sotalol100 in 1 BOTTLETABLET100101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923424sotalol HCl 160 MG Oral TabletPSN5962c4ee-c8f7-4e38-ab8c-4848c7644362101
1923424sotalol hydrochloride 160 MG Oral TabletSCD5962c4ee-c8f7-4e38-ab8c-4848c7644362101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2523-172162252301100 TABLET in 1 BOTTLE (72162-2523-1) 100 tablet2017-12-06NoNoHistorical