FDA.reportPublic FDA data

Sotalol Hydrochloride

Product NDC
71335-0260
11-digit product format
713350260
Labeler code
71335
Product ID
71335-0260_deff5b14-286a-444c-9ee0-20722efba148
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-0260-1Sotalol Hydrochloride60 in 1 BOTTLETABLET6010
71335-0260-2Sotalol Hydrochloride30 in 1 BOTTLETABLET3010
71335-0260-3Sotalol Hydrochloride100 in 1 BOTTLETABLET10010
71335-0260-4Sotalol Hydrochloride90 in 1 BOTTLETABLET9010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0260SOTALOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 4 package rows20241109_876214ba-59c4-4acc-a8ad-c6bc91837de8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923426sotalol HCl 80 MG Oral TabletPSN876214ba-59c4-4acc-a8ad-c6bc91837de810
1923426sotalol hydrochloride 80 MG Oral TabletSCD876214ba-59c4-4acc-a8ad-c6bc91837de810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0260-17133502600160 TABLET in 1 BOTTLE (71335-0260-1) 60 tablet2020-07-140000-00-00NoNoCurrent
71335-0260-27133502600230 TABLET in 1 BOTTLE (71335-0260-2) 30 tablet2020-07-140000-00-00NoNoCurrent
71335-0260-371335026003100 TABLET in 1 BOTTLE (71335-0260-3) 100 tablet2024-10-300000-00-00NoNoCurrent
71335-0260-47133502600490 TABLET in 1 BOTTLE (71335-0260-4) 90 tablet2024-10-30NoNoCurrent