FDA.reportPublic FDA data

Sotalol Hydrochloride

Product NDC
69584-842
11-digit product format
695840842
Labeler code
69584
Product ID
69584-842_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
120 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 HYDROCHLORIDE120 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
69584-842-10Sotalol Hydrochloride100 in 1 BOTTLETABLET1004
69584-842-30Sotalol Hydrochloride300 in 1 BOTTLETABLET3004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69584-842-10EA - Each69584-842589be025-805f-4904-815b-e7da7029b47a12020-07-13
69584-842-30EA - Each69584-8423dfc8735-6a46-4009-9729-cb12a4888ad412025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69584-842SOTALOL 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
1923422sotalol HCl 120 MG Oral TabletPSN9a36d95c-6e93-4e57-befe-b5274f359244104
1923422sotalol hydrochloride 120 MG Oral TabletSCD9a36d95c-6e93-4e57-befe-b5274f359244104
1923422sotalol HCl 120 MG Oral TabletPSN0fd4afc7-dbf8-46be-9657-aa83bbb2c026101
1923422sotalol hydrochloride 120 MG Oral TabletSCD0fd4afc7-dbf8-46be-9657-aa83bbb2c026101
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
1923422sotalol HCl 120 MG Oral TabletPSN10b7b81d-9ce7-4025-8559-fdfa41c8b1461
1923422sotalol hydrochloride 120 MG Oral TabletSCD10b7b81d-9ce7-4025-8559-fdfa41c8b1461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69584-842-1069584084210100 TABLET in 1 BOTTLE (69584-842-10) 100 tablet2020-07-240000-00-00NoNoCurrent
69584-842-3069584084230300 TABLET in 1 BOTTLE (69584-842-30) 300 tablet2020-07-240000-00-00NoNoCurrent