FDA.reportPublic FDA data

Sotalol Hydrochloride

Product NDC
71610-474
11-digit product format
716100474
Labeler code
71610
Product ID
71610-474_c2c1a3a6-f70e-4b47-85b6-e4d10c110588
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
71610-474-60Sotalol Hydrochloride90 in 1 BOTTLETABLET902
71610-474-80Sotalol Hydrochloride180 in 1 BOTTLETABLET1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-474-60EA - Each71610-4743098c88e-4a9b-4930-9b35-5902822418ec12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-474SOTALOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 2 package rows20220223_253da1e1-022a-4175-bd7f-e7673cba0767.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923426sotalol HCl 80 MG Oral TabletPSN253da1e1-022a-4175-bd7f-e7673cba07672
1923426sotalol hydrochloride 80 MG Oral TabletSCD253da1e1-022a-4175-bd7f-e7673cba07672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-474-607161004746090 TABLET in 1 BOTTLE (71610-474-60) 90 tablet2022-01-250000-00-00NoNoCurrent
71610-474-8071610047480180 TABLET in 1 BOTTLE (71610-474-80) 180 tablet2020-10-150000-00-00NoNoCurrent