FDA.reportPublic FDA data

Sotalol hydrochloride

Product NDC
69724-112
11-digit product format
697240112
Labeler code
69724
Product ID
69724-112_d155f318-ecbf-4392-90a1-4409c5b8d13f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
ALTATHERA Pharmaceuticals, LLC
Application
NDA022306
Marketing category
NDA
Marketing start
2015-10-15
Substance
SOTALOL HYDROCHLORIDE
Active strength
15 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
Sotalol hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOTALOL HYDROCHLORIDE15 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHEC37C70XX
Rxcui904630

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83083289-08f8-450a-8eff-9d912bdd64bbProduct name120200505
8b3790df-333b-074c-6570-5beaa3352b77Product name220190213
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
424d69b0-0855-4fff-846d-7ced5f554385Product name120150403
9ab69b37-6a2f-6dca-a9fd-3131946f16f2Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69724-112-10Sotalol hydrochloride1 in 1 CARTONINJECTION115
69724-112-10Sotalol hydrochloride10 mL in 1 VIALINJECTION1015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69724-112-10ML - Milliliter69724-112e07344db-4aec-4ae1-a9a4-736a0390edcc12016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SOTALOL HYDROCHLORIDEACTIVE INGREDIENTHEC37C70XXSOTALOL HYDROCHLORIDE INJECTION [ALTATHERA PHARMACEUTICALS, LLC]3
SOTALOLACTIVE MOIETYA6D97U294ISOTALOL HYDROCHLORIDE INJECTION [ALTATHERA PHARMACEUTICALS, LLC]3
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PSOTALOL HYDROCHLORIDE INJECTION [ALTATHERA PHARMACEUTICALS, LLC]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISOTALOL HYDROCHLORIDE INJECTION [ALTATHERA PHARMACEUTICALS, LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RSOTALOL HYDROCHLORIDE INJECTION [ALTATHERA PHARMACEUTICALS, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69724-112SOTALOL HYDROCHLORIDE INJECTION [ALTATHERA PHARMACEUTICALS, LLC]13Current NDC, Legacy NDC, 2 package rows20231006_ff3061ab-d930-4318-a5be-684e38be229e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904630sotalol HCl 150 MG in 10 ML InjectionPSNff3061ab-d930-4318-a5be-684e38be229e15
90463010 ML sotalol hydrochloride 15 MG/ML InjectionSCDff3061ab-d930-4318-a5be-684e38be229e15
904630sotalol hydrochloride 150 MG per 10 ML InjectionSYff3061ab-d930-4318-a5be-684e38be229e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69724-112-10697240112101 VIAL in 1 CARTON (69724-112-10) / 10 mL in 1 VIAL1 vial2015-10-150000-00-00NoNoCurrent