FDA.reportPublic FDA data

Sotalol Hydrochloride

Product NDC
60429-750
11-digit product format
604290750
Labeler code
60429
Product ID
60429-750_e7a53ef6-e014-36bb-e053-2a95a90a4bb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA076140
Marketing category
ANDA
Marketing start
2002-09-26
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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
60429-750-01Sotalol Hydrochloride100 in 1 BOTTLETABLET10017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-750-01EA - Each60429-75086ea1b27-31ff-4c96-8cca-f01823b3448412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SOTALOL HYDROCHLORIDEACTIVE INGREDIENTHEC37C70XXSOTALOL HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SOTALOLACTIVE MOIETYA6D97U294ISOTALOL HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USOTALOL HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SOTALOL HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-750SOTALOL HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]16Legacy NDC, 1 package rows20241212_6674d53a-7137-4822-8841-4982f702a1b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923422sotalol HCl 120 MG Oral TabletPSN6674d53a-7137-4822-8841-4982f702a1b817
1923424sotalol HCl 160 MG Oral TabletPSN6674d53a-7137-4822-8841-4982f702a1b817
904589sotalol HCl 240 MG Oral TabletPSN6674d53a-7137-4822-8841-4982f702a1b817
1923426sotalol HCl 80 MG Oral TabletPSN6674d53a-7137-4822-8841-4982f702a1b817
1923422sotalol hydrochloride 120 MG Oral TabletSCD6674d53a-7137-4822-8841-4982f702a1b817
1923424sotalol hydrochloride 160 MG Oral TabletSCD6674d53a-7137-4822-8841-4982f702a1b817
904589sotalol hydrochloride 240 MG Oral TabletSCD6674d53a-7137-4822-8841-4982f702a1b817
1923426sotalol hydrochloride 80 MG Oral TabletSCD6674d53a-7137-4822-8841-4982f702a1b817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-750-0160429075001100 TABLET in 1 BOTTLE (60429-750-01) 100 tablet2003-02-010000-00-00NoNoCurrent