FDA.reportPublic FDA data

Sotalol

Product NDC
76385-116
11-digit product format
763850116
Labeler code
76385
Product ID
76385-116_fe9ac463-547d-4917-a98e-61f1c0fe38f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
UNICHEM PHARMACEUTICALS (USA), INC.
Application
ANDA207428
Marketing category
ANDA
Marketing start
2017-12-06
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sotalol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOTALOL HYDROCHLORIDE160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHEC37C70XX
Rxcui1922720, 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
76385-116-01Sotalol100 in 1 BOTTLE, PLASTICTABLET1005
76385-116-50Sotalol500 in 1 BOTTLE, PLASTICTABLET5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76385-116-01EA - Each76385-11607b9a770-d91a-4a66-9801-4714e7fad91012018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76385-116SOTALOL (SOTALOL HYDROCHLORIDE) TABLET [BAYSHORE PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 2 package rows20240118_56879738-8662-4f5c-8386-761ab2b5e46f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923424sotalol HCl 160 MG Oral TabletPSN5962c4ee-c8f7-4e38-ab8c-4848c7644362101
1923424sotalol hydrochloride 160 MG Oral TabletSCD5962c4ee-c8f7-4e38-ab8c-4848c7644362101
1923422sotalol HCl 120 MG Oral TabletPSN56879738-8662-4f5c-8386-761ab2b5e46f5
1923424sotalol HCl 160 MG Oral TabletPSN56879738-8662-4f5c-8386-761ab2b5e46f5
1923426sotalol HCl 80 MG Oral TabletPSN56879738-8662-4f5c-8386-761ab2b5e46f5
1922720sotalol HCl AF 120 MG Oral TabletPSN56879738-8662-4f5c-8386-761ab2b5e46f5
1922763sotalol HCl AF 160 MG Oral TabletPSN56879738-8662-4f5c-8386-761ab2b5e46f5
1922765sotalol HCl AF 80 MG Oral TabletPSN56879738-8662-4f5c-8386-761ab2b5e46f5
1922720Atrial Fibrillation sotalol hydrochloride 120 MG Oral TabletSCD56879738-8662-4f5c-8386-761ab2b5e46f5
1922763Atrial Fibrillation sotalol hydrochloride 160 MG Oral TabletSCD56879738-8662-4f5c-8386-761ab2b5e46f5
1922765Atrial Fibrillation sotalol hydrochloride 80 MG Oral TabletSCD56879738-8662-4f5c-8386-761ab2b5e46f5
1923422sotalol hydrochloride 120 MG Oral TabletSCD56879738-8662-4f5c-8386-761ab2b5e46f5
1923424sotalol hydrochloride 160 MG Oral TabletSCD56879738-8662-4f5c-8386-761ab2b5e46f5
1923426sotalol hydrochloride 80 MG Oral TabletSCD56879738-8662-4f5c-8386-761ab2b5e46f5
1922763sotalol HCl AF 160 MG Oral TabletSY56879738-8662-4f5c-8386-761ab2b5e46f5
1922765sotalol HCl AF 80 MG Oral TabletSY56879738-8662-4f5c-8386-761ab2b5e46f5
1922720sotalol hydrochloride AF 120 MG Oral TabletSY56879738-8662-4f5c-8386-761ab2b5e46f5
1923422sotalol HCl 120 MG Oral TabletPSN3c24cdf0-4648-4e5d-993c-1f428ce56a654
1923424sotalol HCl 160 MG Oral TabletPSN3c24cdf0-4648-4e5d-993c-1f428ce56a654
1923426sotalol HCl 80 MG Oral TabletPSN3c24cdf0-4648-4e5d-993c-1f428ce56a654
1923422sotalol hydrochloride 120 MG Oral TabletSCD3c24cdf0-4648-4e5d-993c-1f428ce56a654
1923424sotalol hydrochloride 160 MG Oral TabletSCD3c24cdf0-4648-4e5d-993c-1f428ce56a654
1923426sotalol hydrochloride 80 MG Oral TabletSCD3c24cdf0-4648-4e5d-993c-1f428ce56a654

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76385-116-0176385011601100 TABLET in 1 BOTTLE, PLASTIC (76385-116-01) 100 tablet2017-12-060000-00-00NoNoCurrent
76385-116-5076385011650500 TABLET in 1 BOTTLE, PLASTIC (76385-116-50) 500 tablet2017-12-060000-00-00NoNoCurrent