FDA.reportPublic FDA data

Sotalol Hydrochloride

Product NDC
50090-1299
11-digit product format
500901299
Labeler code
50090
Product ID
50090-1299_2b35de26-dca3-4508-b0c4-f9bdea0e41da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
Rxcui1923426

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
50090-1299-0Sotalol Hydrochloride60 in 1 BOTTLETABLET6016
50090-1299-1Sotalol Hydrochloride30 in 1 BOTTLETABLET3016
50090-1299-2Sotalol Hydrochloride90 in 1 BOTTLETABLET9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1299-0EA - Each50090-129972b1f52b-68bf-408c-a0b8-24f81fd3030a12018-11-06
50090-1299-2EA - Each50090-1299c447de39-ac22-44aa-a3e0-61f2d459cac512021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1299SOTALOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]16Current NDC, Legacy NDC, 3 package rows20231210_7cb4879f-31e7-4862-bc0c-d439e592d81c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923426sotalol HCl 80 MG Oral TabletPSN7cb4879f-31e7-4862-bc0c-d439e592d81c16
1923426sotalol hydrochloride 80 MG Oral TabletSCD7cb4879f-31e7-4862-bc0c-d439e592d81c16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1299-05009012990060 TABLET in 1 BOTTLE (50090-1299-0) 60 tablet2014-11-280000-00-00NoNoCurrent
50090-1299-15009012990130 TABLET in 1 BOTTLE (50090-1299-1) 30 tablet2022-02-020000-00-00NoNoCurrent
50090-1299-25009012990290 TABLET in 1 BOTTLE (50090-1299-2) 90 tablet2020-11-040000-00-00NoNoCurrent