FDA.reportPublic FDA data

Sotalol Hydrochloride

Product NDC
82804-974
11-digit product format
828040974
Labeler code
82804
Product ID
82804-974_959dc952-bed6-4538-a1a6-61ed10c06be4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075563
Marketing category
ANDA
Marketing start
2020-07-24
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
82804-974-00Sotalol Hydrochloride100 in 1 BOTTLETABLET1002
82804-974-11Sotalol Hydrochloride1000 in 1 BOTTLETABLET10002
82804-974-30Sotalol Hydrochloride30 in 1 BOTTLETABLET302
82804-974-55Sotalol Hydrochloride500 in 1 BOTTLETABLET5002
82804-974-60Sotalol Hydrochloride60 in 1 BOTTLETABLET602
82804-974-72Sotalol Hydrochloride120 in 1 BOTTLETABLET1202
82804-974-90Sotalol Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-974SOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP]2Current NDC, 7 package rows20250221_b534c632-3b67-4812-a045-3e582eda6de4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923426sotalol HCl 80 MG Oral TabletPSNb534c632-3b67-4812-a045-3e582eda6de42
1923426sotalol hydrochloride 80 MG Oral TabletSCDb534c632-3b67-4812-a045-3e582eda6de42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-974-0082804097400100 TABLET in 1 BOTTLE (82804-974-00) 100 tablet2025-02-13NoNoCurrent
82804-974-11828040974111000 TABLET in 1 BOTTLE (82804-974-11) 1000 tablet2025-02-13NoNoCurrent
82804-974-308280409743030 TABLET in 1 BOTTLE (82804-974-30) 30 tablet2025-02-13NoNoCurrent
82804-974-5582804097455500 TABLET in 1 BOTTLE (82804-974-55) 500 tablet2025-02-13NoNoCurrent
82804-974-608280409746060 TABLET in 1 BOTTLE (82804-974-60) 60 tablet2025-02-13NoNoCurrent
82804-974-7282804097472120 TABLET in 1 BOTTLE (82804-974-72) 120 tablet2025-02-13NoNoCurrent
82804-974-908280409749090 TABLET in 1 BOTTLE (82804-974-90) 90 tablet2025-02-13NoNoCurrent