FDA.reportPublic FDA data

Sotalol Hydrochloride

Product NDC
71610-723
11-digit product format
716100723
Labeler code
71610
Product ID
71610-723_15689e23-7236-4cfd-8ab4-9b8450b82299
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076140
Marketing category
ANDA
Marketing start
2002-09-26
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
71610-723-30Sotalol Hydrochloride30 in 1 BOTTLETABLET302
71610-723-60Sotalol Hydrochloride90 in 1 BOTTLETABLET902
71610-723-80Sotalol Hydrochloride180 in 1 BOTTLETABLET1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-723-30EA - Each71610-723b718f404-65bc-4501-ac2b-c6a15bdc2de212023-10-16
71610-723-60EA - Each71610-723f70af082-3a7d-4a82-a7c8-c27b30ba23b512023-10-16
71610-723-80EA - Each71610-7236881f63c-7267-49e7-b5e1-1ded1c5daa0d12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-723SOTALOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, 3 package rows20230809_5e005309-4eca-4536-8743-c6ed9e5b3195.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923426sotalol HCl 80 MG Oral TabletPSN5e005309-4eca-4536-8743-c6ed9e5b31952
1923426sotalol hydrochloride 80 MG Oral TabletSCD5e005309-4eca-4536-8743-c6ed9e5b31952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-723-307161007233030 TABLET in 1 BOTTLE (71610-723-30) 30 tablet2023-08-07NoNoCurrent
71610-723-607161007236090 TABLET in 1 BOTTLE (71610-723-60) 90 tablet2023-08-07NoNoCurrent
71610-723-8071610072380180 TABLET in 1 BOTTLE (71610-723-80) 180 tablet2023-08-07NoNoCurrent