FDA.reportPublic FDA data

Sotalol

Product NDC
10135-663
11-digit product format
101350663
Labeler code
10135
Product ID
10135-663_d21adcb6-0083-7e25-e053-2a95a90a406d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA207428
Marketing category
ANDA
Marketing start
2018-10-01
Marketing end
0000-00-00
Substance
SOTALOL HYDROCHLORIDE
Active strength
160 mg/1
Pharmacologic classes
Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-663-012023-01-30C16284748780-19d75b9d1-149d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS. SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992
10135-663-012020-02-20C16284748780-19d75b9d1-149d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS. SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992
10135-663-012020-01-31C16284748780-19d75b9d1-149d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS. SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-663-01Sotalol100 in 1 BOTTLE, PLASTICTABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-663-01EA - Each10135-6638fe9e68c-a770-4d61-88ea-8a26fe2b4dbb12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-663SOTALOL (SOTALOL HYDROCHLORIDE) TABLET [MARLEX PHARMACEUTICALS INC]4Legacy NDC, 1 package rows20211202_3c24cdf0-4648-4e5d-993c-1f428ce56a65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923422sotalol HCl 120 MG Oral TabletPSN3c24cdf0-4648-4e5d-993c-1f428ce56a654
1923424sotalol HCl 160 MG Oral TabletPSN3c24cdf0-4648-4e5d-993c-1f428ce56a654
1923426sotalol HCl 80 MG Oral TabletPSN3c24cdf0-4648-4e5d-993c-1f428ce56a654
1923422sotalol hydrochloride 120 MG Oral TabletSCD3c24cdf0-4648-4e5d-993c-1f428ce56a654
1923424sotalol hydrochloride 160 MG Oral TabletSCD3c24cdf0-4648-4e5d-993c-1f428ce56a654
1923426sotalol hydrochloride 80 MG Oral TabletSCD3c24cdf0-4648-4e5d-993c-1f428ce56a654

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-663-0110135066301100 TABLET in 1 BOTTLE, PLASTIC (10135-663-01) 100 tablet2018-10-010000-00-00NoNoCurrent