FDA.reportPublic FDA data

Sotalol Hydrochloride

Product NDC
60505-0080
11-digit product format
605050080
Labeler code
60505
Product ID
60505-0080_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
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
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
60505-0080-0Sotalol Hydrochloride100 in 1 BOTTLETABLET10017
60505-0080-1Sotalol Hydrochloride1000 in 1 BOTTLETABLET100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0080-0EA - Each60505-0080b544ff52-1a27-4fef-b433-224a14caec9912012-07-24

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 [AMERICAN HEALTH PACKAGING]1
SOTALOL HYDROCHLORIDEACTIVE INGREDIENTHEC37C70XXSOTALOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SOTALOL HYDROCHLORIDEACTIVE INGREDIENTHEC37C70XXSOTALOL HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SOTALOLACTIVE MOIETYA6D97U294ISOTALOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]1
SOTALOLACTIVE MOIETYA6D97U294ISOTALOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SOTALOLACTIVE MOIETYA6D97U294ISOTALOL HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USOTALOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USOTALOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USOTALOL HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SOTALOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SOTALOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]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
60505-0080SOTALOL 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
1923426sotalol HCl 80 MG Oral TabletPSNbc35a3e8-681c-4fe8-96cd-b2a62f024c4b102
1923426sotalol hydrochloride 80 MG Oral TabletSCDbc35a3e8-681c-4fe8-96cd-b2a62f024c4b102
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 TabletPSN1a56c82e-7ecd-43b0-2899-f89e47adf7db17
1923426sotalol HCl 80 MG Oral TabletPSN6674d53a-7137-4822-8841-4982f702a1b817
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 TabletSCD1a56c82e-7ecd-43b0-2899-f89e47adf7db17
1923426sotalol hydrochloride 80 MG Oral TabletSCD6674d53a-7137-4822-8841-4982f702a1b817
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
1923426sotalol HCl 80 MG Oral TabletPSN7cb4879f-31e7-4862-bc0c-d439e592d81c16
1923426sotalol hydrochloride 80 MG Oral TabletSCD7cb4879f-31e7-4862-bc0c-d439e592d81c16
1923426sotalol HCl 80 MG Oral TabletPSN876214ba-59c4-4acc-a8ad-c6bc91837de810
1923426sotalol hydrochloride 80 MG Oral TabletSCD876214ba-59c4-4acc-a8ad-c6bc91837de810
1923426sotalol HCl 80 MG Oral TabletPSN4614480b-b36e-4dbd-9fc0-d083890d297d9
1923426sotalol hydrochloride 80 MG Oral TabletSCD4614480b-b36e-4dbd-9fc0-d083890d297d9
1923426sotalol HCl 80 MG Oral TabletPSN517824b1-11be-40a9-9066-d1a6a32a29385
1923426sotalol hydrochloride 80 MG Oral TabletSCD517824b1-11be-40a9-9066-d1a6a32a29385
1923426sotalol HCl 80 MG Oral TabletPSN866e5717-3de2-4f19-b7c7-2275caeef78b4
1923426sotalol hydrochloride 80 MG Oral TabletSCD866e5717-3de2-4f19-b7c7-2275caeef78b4
1923422sotalol HCl 120 MG Oral TabletPSNbcbc1624-283e-732f-e053-2995a90a8f113
1923426sotalol HCl 80 MG Oral TabletPSNbcbc1624-283e-732f-e053-2995a90a8f113
1923422sotalol hydrochloride 120 MG Oral TabletSCDbcbc1624-283e-732f-e053-2995a90a8f113
1923426sotalol hydrochloride 80 MG Oral TabletSCDbcbc1624-283e-732f-e053-2995a90a8f113
1923426sotalol HCl 80 MG Oral TabletPSN6481858a-353e-4b2a-af48-6c5d13ee0b2a1
1923426sotalol HCl 80 MG Oral TabletPSN1f2ee505-eb90-885d-e063-6394a90a46a11
1923426sotalol hydrochloride 80 MG Oral TabletSCD6481858a-353e-4b2a-af48-6c5d13ee0b2a1
1923426sotalol hydrochloride 80 MG Oral TabletSCD1f2ee505-eb90-885d-e063-6394a90a46a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0080-060505008000100 TABLET in 1 BOTTLE (60505-0080-0) 100 tablet2003-02-010000-00-00NoNoCurrent
60505-0080-1605050080011000 TABLET in 1 BOTTLE (60505-0080-1) 1000 tablet2003-02-010000-00-00NoNoCurrent