FDA.reportPublic FDA data

Sotalol Hydrochloride

Product NDC
60505-0081
11-digit product format
605050081
Labeler code
60505
Product ID
60505-0081_7e1fd07e-45aa-ef32-da1b-c81f6961f216
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA076140
Marketing category
ANDA
Marketing start
2003-02-01
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
Rxcui904589, 1922720, 1922763, 1922765, 1923422, 1923424, 1923426

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
60505-0081-0Sotalol Hydrochloride100 in 1 BOTTLETABLET10017
60505-0081-1Sotalol Hydrochloride1000 in 1 BOTTLETABLET100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0081-0EA - Each60505-0081e16d06f6-6ae9-4edc-a4e8-022bfd98eb5012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SOTALOL HYDROCHLORIDEACTIVE INGREDIENTHEC37C70XXSOTALOL HYDROCHLORIDE TABLET [APOTEX CORP.]8
SOTALOLACTIVE MOIETYA6D97U294ISOTALOL HYDROCHLORIDE TABLET [APOTEX CORP.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USOTALOL HYDROCHLORIDE TABLET [APOTEX CORP.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SOTALOL HYDROCHLORIDE TABLET [APOTEX CORP.]8
SOTALOL HYDROCHLORIDEACTIVE INGREDIENTHEC37C70XXSOTALOL HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SOTALOLACTIVE MOIETYA6D97U294ISOTALOL HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USOTALOL HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SOTALOL HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0081SOTALOL HYDROCHLORIDE TABLET [APOTEX CORP.]16Current NDC, Legacy NDC, 2 package rows20241003_1a56c82e-7ecd-43b0-2899-f89e47adf7db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923422sotalol HCl 120 MG Oral TabletPSN6674d53a-7137-4822-8841-4982f702a1b817
1923422sotalol HCl 120 MG Oral TabletPSN1a56c82e-7ecd-43b0-2899-f89e47adf7db17
1923424sotalol HCl 160 MG Oral TabletPSN6674d53a-7137-4822-8841-4982f702a1b817
1923424sotalol HCl 160 MG Oral TabletPSN1a56c82e-7ecd-43b0-2899-f89e47adf7db17
904589sotalol HCl 240 MG Oral TabletPSN6674d53a-7137-4822-8841-4982f702a1b817
904589sotalol HCl 240 MG Oral TabletPSN1a56c82e-7ecd-43b0-2899-f89e47adf7db17
1923426sotalol HCl 80 MG Oral TabletPSN6674d53a-7137-4822-8841-4982f702a1b817
1923426sotalol HCl 80 MG Oral TabletPSN1a56c82e-7ecd-43b0-2899-f89e47adf7db17
1922720sotalol HCl AF 120 MG Oral TabletPSN1a56c82e-7ecd-43b0-2899-f89e47adf7db17
1922763sotalol HCl AF 160 MG Oral TabletPSN1a56c82e-7ecd-43b0-2899-f89e47adf7db17
1922765sotalol HCl AF 80 MG Oral TabletPSN1a56c82e-7ecd-43b0-2899-f89e47adf7db17
1922720Atrial Fibrillation sotalol hydrochloride 120 MG Oral TabletSCD1a56c82e-7ecd-43b0-2899-f89e47adf7db17
1922763Atrial Fibrillation sotalol hydrochloride 160 MG Oral TabletSCD1a56c82e-7ecd-43b0-2899-f89e47adf7db17
1922765Atrial Fibrillation sotalol hydrochloride 80 MG Oral TabletSCD1a56c82e-7ecd-43b0-2899-f89e47adf7db17
1923422sotalol hydrochloride 120 MG Oral TabletSCD1a56c82e-7ecd-43b0-2899-f89e47adf7db17
1923422sotalol hydrochloride 120 MG Oral TabletSCD6674d53a-7137-4822-8841-4982f702a1b817
1923424sotalol hydrochloride 160 MG Oral TabletSCD6674d53a-7137-4822-8841-4982f702a1b817
1923424sotalol hydrochloride 160 MG Oral TabletSCD1a56c82e-7ecd-43b0-2899-f89e47adf7db17
904589sotalol hydrochloride 240 MG Oral TabletSCD6674d53a-7137-4822-8841-4982f702a1b817
904589sotalol hydrochloride 240 MG Oral TabletSCD1a56c82e-7ecd-43b0-2899-f89e47adf7db17
1923426sotalol hydrochloride 80 MG Oral TabletSCD6674d53a-7137-4822-8841-4982f702a1b817
1923426sotalol hydrochloride 80 MG Oral TabletSCD1a56c82e-7ecd-43b0-2899-f89e47adf7db17
1922763sotalol HCl AF 160 MG Oral TabletSY1a56c82e-7ecd-43b0-2899-f89e47adf7db17
1922765sotalol HCl AF 80 MG Oral TabletSY1a56c82e-7ecd-43b0-2899-f89e47adf7db17
1922720sotalol hydrochloride AF 120 MG Oral TabletSY1a56c82e-7ecd-43b0-2899-f89e47adf7db17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0081-060505008100100 TABLET in 1 BOTTLE (60505-0081-0) 100 tablet2003-02-010000-00-00NoNoCurrent
60505-0081-1605050081011000 TABLET in 1 BOTTLE (60505-0081-1) 1000 tablet2003-02-010000-00-00NoNoCurrent