FDA.reportPublic FDA data

Sotalol Hydrochloride

Product NDC
63187-804
11-digit product format
631870804
Labeler code
63187
Product ID
63187-804_77e00163-ec11-4bba-b1f9-08313bf22310
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076140
Marketing category
ANDA
Marketing start
2003-02-01
Substance
SOTALOL HYDROCHLORIDE
Active strength
80 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sotalol Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOTALOL HYDROCHLORIDE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHEC37C70XX
Rxcui1923426

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
63187-804-30Sotalol Hydrochloride30 in 1 BOTTLETABLET305
63187-804-60Sotalol Hydrochloride60 in 1 BOTTLETABLET605
63187-804-90Sotalol Hydrochloride90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-804-30EA - Each63187-8041bcc310d-edaf-486a-89f3-acff81dcd87212017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-804SOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20230714_517824b1-11be-40a9-9066-d1a6a32a2938.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923426sotalol HCl 80 MG Oral TabletPSN517824b1-11be-40a9-9066-d1a6a32a29385
1923426sotalol hydrochloride 80 MG Oral TabletSCD517824b1-11be-40a9-9066-d1a6a32a29385

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-804-306318708043030 TABLET in 1 BOTTLE (63187-804-30) 30 tablet2017-01-020000-00-00NoNoCurrent
63187-804-606318708046060 TABLET in 1 BOTTLE (63187-804-60) 60 tablet2017-01-020000-00-00NoNoCurrent
63187-804-906318708049090 TABLET in 1 BOTTLE (63187-804-90) 90 tablet2017-01-020000-00-00NoNoCurrent