FDA.reportPublic FDA data

Sotalol Hydrochloride

Product NDC
60429-748
11-digit product format
604290748
Labeler code
60429
Product ID
60429-748_3c55fac0-8327-5685-e063-6294a90a6292
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
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
Rxcui904589, 1923422, 1923424, 1923426

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
60429-748-01Sotalol Hydrochloride100 in 1 BOTTLETABLET10017
60429-748-05Sotalol Hydrochloride500 in 1 BOTTLETABLET50017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-748-01EA - Each60429-748d9ef8acc-b42b-472a-87dc-5c3a0665c59b12013-02-13

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
60429-748SOTALOL HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]16Current NDC, Legacy NDC, 2 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
1923426sotalol HCl 80 MG Oral TabletPSN5e005309-4eca-4536-8743-c6ed9e5b31952
1923426sotalol hydrochloride 80 MG Oral TabletSCD5e005309-4eca-4536-8743-c6ed9e5b31952
1923426sotalol HCl 80 MG Oral TabletPSN7fd1a6a4-e5f7-4f0a-add4-5003fcc426f31
1923426sotalol hydrochloride 80 MG Oral TabletSCD7fd1a6a4-e5f7-4f0a-add4-5003fcc426f31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-748-0160429074801100 TABLET in 1 BOTTLE (60429-748-01) 100 tablet2003-02-010000-00-00NoNoCurrent
60429-748-0560429074805500 TABLET in 1 BOTTLE (60429-748-05) 500 tablet2018-07-130000-00-00NoNoCurrent