Sotalol Hydrochloride

Product NDC
72162-1931
11-digit product format
721621931
Labeler code
72162
Product ID
72162-1931_89b33c45-ece8-496f-9c3a-94ebabf73b1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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
72162-1931-1Sotalol Hydrochloride100 in 1 BOTTLETABLET100101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1931-1EA - Each72162-1931ec3c8dc3-9e14-40db-8104-3c5c0e8ae47a12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1931SOTALOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20240417_89b33c45-ece8-496f-9c3a-94ebabf73b1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923426sotalol HCl 80 MG Oral TabletPSN89b33c45-ece8-496f-9c3a-94ebabf73b1b101
1923426sotalol hydrochloride 80 MG Oral TabletSCD89b33c45-ece8-496f-9c3a-94ebabf73b1b101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1931-172162193101100 TABLET in 1 BOTTLE (72162-1931-1) 100 tablet2020-07-24NoNoHistorical