FDA.reportPublic FDA data

SOTYLIZE

Product NDC
24338-530
11-digit product format
243380530
Labeler code
24338
Product ID
24338-530_73961d33-7149-49f3-8386-91f1b1758ca5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SOTALOL HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Azurity Pharmaceuticals, Inc.
Application
NDA205108
Marketing category
NDA
Marketing start
2015-03-01
Substance
SOTALOL HYDROCHLORIDE
Active strength
5 mg/mL
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
SOTYLIZE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOTALOL HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHEC37C70XX
Rxcui1593725, 1593731

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
83083289-08f8-450a-8eff-9d912bdd64bbProduct name120200505
8b3790df-333b-074c-6570-5beaa3352b77Product name220190213
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
424d69b0-0855-4fff-846d-7ced5f554385Product name120150403
9ab69b37-6a2f-6dca-a9fd-3131946f16f2Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24338-530-25SOTYLIZE250 mL in 1 BOTTLESOLUTION2506
24338-530-48SOTYLIZE480 mL in 1 BOTTLESOLUTION4806

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24338-530-25ML - Milliliter24338-530823c3937-c117-482a-bdc2-a50296d7efe712015-03-03
24338-530-48ML - Milliliter24338-530ae29ad72-fc78-42bf-a571-6ca0f7889ba912015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SOTALOL HYDROCHLORIDEACTIVE INGREDIENTHEC37C70XXSOTYLIZE (SOTALOL HYDROCHLORIDE) SOLUTION [ARBOR PHARMACEUTICALS, INC.]3
SOTALOLACTIVE MOIETYA6D97U294ISOTYLIZE (SOTALOL HYDROCHLORIDE) SOLUTION [ARBOR PHARMACEUTICALS, INC.]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSOTYLIZE (SOTALOL HYDROCHLORIDE) SOLUTION [ARBOR PHARMACEUTICALS, INC.]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSOTYLIZE (SOTALOL HYDROCHLORIDE) SOLUTION [ARBOR PHARMACEUTICALS, INC.]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRSOTYLIZE (SOTALOL HYDROCHLORIDE) SOLUTION [ARBOR PHARMACEUTICALS, INC.]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4SOTYLIZE (SOTALOL HYDROCHLORIDE) SOLUTION [ARBOR PHARMACEUTICALS, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RSOTYLIZE (SOTALOL HYDROCHLORIDE) SOLUTION [ARBOR PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24338-530SOTYLIZE (SOTALOL HYDROCHLORIDE) SOLUTION [AZURITY PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 2 package rows20240130_1f33f900-0777-4a92-a7f7-00cf3d57d95c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1593725sotalol HCl 5 MG in 1 mL Oral SolutionPSN1f33f900-0777-4a92-a7f7-00cf3d57d95c6
1593731Sotylize 5 MG in 1 mL Oral SolutionPSN1f33f900-0777-4a92-a7f7-00cf3d57d95c6
1593731sotalol hydrochloride 5 MG/ML Oral Solution [Sotylize]SBD1f33f900-0777-4a92-a7f7-00cf3d57d95c6
1593725sotalol hydrochloride 5 MG/ML Oral SolutionSCD1f33f900-0777-4a92-a7f7-00cf3d57d95c6
1593725sotalol HCl 5 MG per 1 ML Oral SolutionSY1f33f900-0777-4a92-a7f7-00cf3d57d95c6
1593731Sotylize 5 MG per 1 ML Oral SolutionSY1f33f900-0777-4a92-a7f7-00cf3d57d95c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24338-530-2524338053025250 mL in 1 BOTTLE (24338-530-25) 250 ml2015-03-010000-00-00NoNoCurrent
24338-530-4824338053048480 mL in 1 BOTTLE (24338-530-48) 480 ml2015-03-010000-00-00NoNoCurrent