FDA.reportPublic FDA data

Sotalol Hydrochloride

Product NDC
69584-841
11-digit product format
695840841
Labeler code
69584
Product ID
69584-841_71c67f34-73e1-4e4c-9c72-56f4b9222a88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Oxford Pharmaceuticals, 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
Rxcui904589, 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
69584-841-10Sotalol Hydrochloride100 in 1 BOTTLETABLET1004
69584-841-50Sotalol Hydrochloride500 in 1 BOTTLETABLET5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69584-841-10EA - Each69584-8419c8eb4f5-3084-4570-bcf6-ed52bf1e753c12020-07-13
69584-841-50EA - Each69584-841feaf2250-7811-49d7-8812-9b7a8fa6c1a812022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69584-841SOTALOL HYDROCHLORIDE TABLET [OXFORD PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20231111_c8ac6351-b1e9-4dd2-82f2-5980814fda15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923426sotalol HCl 80 MG Oral TabletPSN667fc1f2-6ccf-4373-89d8-6a064ee7509e107
1923426sotalol hydrochloride 80 MG Oral TabletSCD667fc1f2-6ccf-4373-89d8-6a064ee7509e107
1923426sotalol HCl 80 MG Oral TabletPSN2f13a6dd-dd77-47c8-ac5d-4a746c32dbd0103
1923426sotalol hydrochloride 80 MG Oral TabletSCD2f13a6dd-dd77-47c8-ac5d-4a746c32dbd0103
1923426sotalol HCl 80 MG Oral TabletPSN89b33c45-ece8-496f-9c3a-94ebabf73b1b101
1923426sotalol hydrochloride 80 MG Oral TabletSCD89b33c45-ece8-496f-9c3a-94ebabf73b1b101
1923426sotalol HCl 80 MG Oral TabletPSNd6c8f659-1c32-4431-bdb2-3211a1c81006100
1923426sotalol hydrochloride 80 MG Oral TabletSCDd6c8f659-1c32-4431-bdb2-3211a1c81006100
1923422sotalol HCl 120 MG Oral TabletPSNe6ea445d-4d7c-4c32-83a7-e7683a56075b8
1923424sotalol HCl 160 MG Oral TabletPSNe6ea445d-4d7c-4c32-83a7-e7683a56075b8
904589sotalol HCl 240 MG Oral TabletPSNe6ea445d-4d7c-4c32-83a7-e7683a56075b8
1923426sotalol HCl 80 MG Oral TabletPSNe6ea445d-4d7c-4c32-83a7-e7683a56075b8
1923422sotalol hydrochloride 120 MG Oral TabletSCDe6ea445d-4d7c-4c32-83a7-e7683a56075b8
1923424sotalol hydrochloride 160 MG Oral TabletSCDe6ea445d-4d7c-4c32-83a7-e7683a56075b8
904589sotalol hydrochloride 240 MG Oral TabletSCDe6ea445d-4d7c-4c32-83a7-e7683a56075b8
1923426sotalol hydrochloride 80 MG Oral TabletSCDe6ea445d-4d7c-4c32-83a7-e7683a56075b8
1923422sotalol HCl 120 MG Oral TabletPSNc8ac6351-b1e9-4dd2-82f2-5980814fda154
1923424sotalol HCl 160 MG Oral TabletPSNc8ac6351-b1e9-4dd2-82f2-5980814fda154
904589sotalol HCl 240 MG Oral TabletPSNc8ac6351-b1e9-4dd2-82f2-5980814fda154
1923426sotalol HCl 80 MG Oral TabletPSNc8ac6351-b1e9-4dd2-82f2-5980814fda154
1923422sotalol hydrochloride 120 MG Oral TabletSCDc8ac6351-b1e9-4dd2-82f2-5980814fda154
1923424sotalol hydrochloride 160 MG Oral TabletSCDc8ac6351-b1e9-4dd2-82f2-5980814fda154
904589sotalol hydrochloride 240 MG Oral TabletSCDc8ac6351-b1e9-4dd2-82f2-5980814fda154
1923426sotalol hydrochloride 80 MG Oral TabletSCDc8ac6351-b1e9-4dd2-82f2-5980814fda154
1923426sotalol HCl 80 MG Oral TabletPSNbbeaba9f-0513-4980-bc29-7f9259a53ecc3
1923426sotalol hydrochloride 80 MG Oral TabletSCDbbeaba9f-0513-4980-bc29-7f9259a53ecc3
1923426sotalol HCl 80 MG Oral TabletPSNb534c632-3b67-4812-a045-3e582eda6de42
1923426sotalol HCl 80 MG Oral TabletPSN253da1e1-022a-4175-bd7f-e7673cba07672
1923426sotalol hydrochloride 80 MG Oral TabletSCD253da1e1-022a-4175-bd7f-e7673cba07672
1923426sotalol hydrochloride 80 MG Oral TabletSCDb534c632-3b67-4812-a045-3e582eda6de42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69584-841-1069584084110100 TABLET in 1 BOTTLE (69584-841-10) 100 tablet2020-07-240000-00-00NoNoCurrent
69584-841-5069584084150500 TABLET in 1 BOTTLE (69584-841-50) 500 tablet2020-07-240000-00-00NoNoCurrent