Sotalol Hydrochloride

Product NDC
71610-294
11-digit product format
716100294
Labeler code
71610
Product ID
71610-294_1ee28057-2ec3-4eb1-a953-af0b4cb6246f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076140
Marketing category
ANDA
Marketing start
2003-02-01
Marketing end
0000-00-00
Substance
SOTALOL HYDROCHLORIDE
Active strength
80 mg/1
Pharmacologic classes
Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-294-30Sotalol Hydrochloride30 in 1 BOTTLETABLET301
71610-294-60Sotalol Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-294-30EA - Each71610-2941d8e32a3-d58a-4686-980c-89312abcb65712019-07-02
71610-294-60EA - Each71610-294125e8ec4-fe6c-4dda-9131-ae4735e36c7812019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-294SOTALOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 2 package rows20190610_7fd1a6a4-e5f7-4f0a-add4-5003fcc426f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
71610-294-307161002943030 TABLET in 1 BOTTLE (71610-294-30) 30 tablet2019-06-060000-00-00NoNoCurrent
71610-294-607161002946090 TABLET in 1 BOTTLE (71610-294-60) 90 tablet2019-06-060000-00-00NoNoCurrent