FDA.reportPublic FDA data

Sotalol Hydrochloride

Product NDC
82804-951
11-digit product format
828040951
Labeler code
82804
Product ID
82804-951_10b7b81d-9ce7-4025-8559-fdfa41c8b146
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
120 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 Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOTALOL HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHEC37C70XX
Rxcui1923422

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
82804-951-00Sotalol Hydrochloride100 in 1 BOTTLETABLET1001
82804-951-11Sotalol Hydrochloride1000 in 1 BOTTLETABLET10001
82804-951-30Sotalol Hydrochloride30 in 1 BOTTLETABLET301
82804-951-55Sotalol Hydrochloride500 in 1 BOTTLETABLET5001
82804-951-60Sotalol Hydrochloride60 in 1 BOTTLETABLET601
82804-951-72Sotalol Hydrochloride120 in 1 BOTTLETABLET1201
82804-951-90Sotalol Hydrochloride90 in 1 BOTTLETABLET901
82804-951-96Sotalol Hydrochloride300 in 1 BOTTLETABLET3001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923422sotalol HCl 120 MG Oral TabletPSN10b7b81d-9ce7-4025-8559-fdfa41c8b1461
1923422sotalol hydrochloride 120 MG Oral TabletSCD10b7b81d-9ce7-4025-8559-fdfa41c8b1461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-951-0082804095100100 TABLET in 1 BOTTLE (82804-951-00) 100 tablet2026-01-12NoNoCurrent
82804-951-11828040951111000 TABLET in 1 BOTTLE (82804-951-11) 1000 tablet2026-01-12NoNoCurrent
82804-951-308280409513030 TABLET in 1 BOTTLE (82804-951-30) 30 tablet2026-01-12NoNoCurrent
82804-951-5582804095155500 TABLET in 1 BOTTLE (82804-951-55) 500 tablet2026-01-12NoNoCurrent
82804-951-608280409516060 TABLET in 1 BOTTLE (82804-951-60) 60 tablet2026-01-12NoNoCurrent
82804-951-7282804095172120 TABLET in 1 BOTTLE (82804-951-72) 120 tablet2026-01-12NoNoCurrent
82804-951-908280409519090 TABLET in 1 BOTTLE (82804-951-90) 90 tablet2026-01-12NoNoCurrent
82804-951-9682804095196300 TABLET in 1 BOTTLE (82804-951-96) 300 tablet2026-01-12NoNoCurrent