FDA.reportPublic FDA data

Sotalol hydrochloride

Product NDC
42806-123
11-digit product format
428060123
Labeler code
42806
Product ID
42806-123_34ed0846-81bd-46c4-a57c-b617c7d8232d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sotalol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA077070
Marketing category
ANDA
Marketing start
2016-01-04
Substance
SOTALOL HYDROCHLORIDE
Active strength
160 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 HYDROCHLORIDE160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHEC37C70XX
Rxcui1922720, 1922763, 1922765

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
42806-123-01Sotalol hydrochloride100 in 1 BOTTLETABLET1009
42806-123-10Sotalol hydrochloride1000 in 1 BOTTLETABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-123-01EA - Each42806-123ffd97d26-b990-45b5-9834-e6978ca8f6f512017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-123SOTALOL HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]8Current NDC, Legacy NDC, 2 package rows20241222_c0a34c56-9641-4592-9754-bcc233ec86b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1922720sotalol HCl AF 120 MG Oral TabletPSNc0a34c56-9641-4592-9754-bcc233ec86b69
1922763sotalol HCl AF 160 MG Oral TabletPSNc0a34c56-9641-4592-9754-bcc233ec86b69
1922765sotalol HCl AF 80 MG Oral TabletPSNc0a34c56-9641-4592-9754-bcc233ec86b69
1922720Atrial Fibrillation sotalol hydrochloride 120 MG Oral TabletSCDc0a34c56-9641-4592-9754-bcc233ec86b69
1922763Atrial Fibrillation sotalol hydrochloride 160 MG Oral TabletSCDc0a34c56-9641-4592-9754-bcc233ec86b69
1922765Atrial Fibrillation sotalol hydrochloride 80 MG Oral TabletSCDc0a34c56-9641-4592-9754-bcc233ec86b69
1922763sotalol HCl AF 160 MG Oral TabletSYc0a34c56-9641-4592-9754-bcc233ec86b69
1922765sotalol HCl AF 80 MG Oral TabletSYc0a34c56-9641-4592-9754-bcc233ec86b69
1922720sotalol hydrochloride AF 120 MG Oral TabletSYc0a34c56-9641-4592-9754-bcc233ec86b69

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-123-0142806012301100 TABLET in 1 BOTTLE (42806-123-01) 100 tablet2016-01-040000-00-00NoNoCurrent
42806-123-10428060123101000 TABLET in 1 BOTTLE (42806-123-10) 1000 tablet2016-01-040000-00-00NoNoCurrent