FDA.reportPublic FDA data

BETAPACE

Product NDC
70515-109
11-digit product format
705150109
Labeler code
70515
Product ID
70515-109_1b3fb38e-5546-4a55-866f-d2e2ffadaed8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sotalol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Covis Pharma US, Inc
Application
NDA019865
Marketing category
NDA
Marketing start
2016-09-01
Marketing end
0000-00-00
Substance
SOTALOL HYDROCHLORIDE
Active strength
120 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70515-109-102025-01-30C16284748780-12cef2736-8037-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use BETAPACE ® /BETAPACE AF safely and effectively. See full prescribing information for BETAPACE/BETAPACE AF. BETAPACE (sotalol hydrochloride) tablets, for oral use BETAPACE AF (sotalol hydrochloride) tablets, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70515-109-10BETAPACE100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70515-109-10EA - Each70515-10932bae903-c9c2-4e39-85b2-8b0dd12fa7c812017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70515-109BETAPACE (SOTALOL HYDROCHLORIDE) TABLET BETAPACE AF (SOTALOL HYDROCHLORIDE) TABLET [COVIS PHARMA US, INC]6Legacy NDC, 1 package rows20230629_afce2787-8899-4098-87c8-f1e8dd19e6dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923423Betapace 120 MG Oral TabletPSNafce2787-8899-4098-87c8-f1e8dd19e6dd6
1923425Betapace 160 MG Oral TabletPSNafce2787-8899-4098-87c8-f1e8dd19e6dd6
1923427Betapace 80 MG Oral TabletPSNafce2787-8899-4098-87c8-f1e8dd19e6dd6
1922721Betapace AF 120 MG Oral TabletPSNafce2787-8899-4098-87c8-f1e8dd19e6dd6
1922764Betapace AF 160 MG Oral TabletPSNafce2787-8899-4098-87c8-f1e8dd19e6dd6
1922766Betapace AF 80 MG Oral TabletPSNafce2787-8899-4098-87c8-f1e8dd19e6dd6
1923422sotalol HCl 120 MG Oral TabletPSNafce2787-8899-4098-87c8-f1e8dd19e6dd6
1923424sotalol HCl 160 MG Oral TabletPSNafce2787-8899-4098-87c8-f1e8dd19e6dd6
1923426sotalol HCl 80 MG Oral TabletPSNafce2787-8899-4098-87c8-f1e8dd19e6dd6
1922720sotalol HCl AF 120 MG Oral TabletPSNafce2787-8899-4098-87c8-f1e8dd19e6dd6
1922763sotalol HCl AF 160 MG Oral TabletPSNafce2787-8899-4098-87c8-f1e8dd19e6dd6
1922765sotalol HCl AF 80 MG Oral TabletPSNafce2787-8899-4098-87c8-f1e8dd19e6dd6
1922721Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet [Betapace]SBDafce2787-8899-4098-87c8-f1e8dd19e6dd6
1922764Atrial Fibrillation sotalol hydrochloride 160 MG Oral Tablet [Betapace]SBDafce2787-8899-4098-87c8-f1e8dd19e6dd6
1922766Atrial Fibrillation sotalol hydrochloride 80 MG Oral Tablet [Betapace]SBDafce2787-8899-4098-87c8-f1e8dd19e6dd6
1923423sotalol hydrochloride 120 MG Oral Tablet [Betapace]SBDafce2787-8899-4098-87c8-f1e8dd19e6dd6
1923425sotalol hydrochloride 160 MG Oral Tablet [Betapace]SBDafce2787-8899-4098-87c8-f1e8dd19e6dd6
1923427sotalol hydrochloride 80 MG Oral Tablet [Betapace]SBDafce2787-8899-4098-87c8-f1e8dd19e6dd6
1922720Atrial Fibrillation sotalol hydrochloride 120 MG Oral TabletSCDafce2787-8899-4098-87c8-f1e8dd19e6dd6
1922763Atrial Fibrillation sotalol hydrochloride 160 MG Oral TabletSCDafce2787-8899-4098-87c8-f1e8dd19e6dd6
1922765Atrial Fibrillation sotalol hydrochloride 80 MG Oral TabletSCDafce2787-8899-4098-87c8-f1e8dd19e6dd6
1923422sotalol hydrochloride 120 MG Oral TabletSCDafce2787-8899-4098-87c8-f1e8dd19e6dd6
1923424sotalol hydrochloride 160 MG Oral TabletSCDafce2787-8899-4098-87c8-f1e8dd19e6dd6
1923426sotalol hydrochloride 80 MG Oral TabletSCDafce2787-8899-4098-87c8-f1e8dd19e6dd6
1922721Atrial Fibrillation Betapace 120 MG Oral TabletSYafce2787-8899-4098-87c8-f1e8dd19e6dd6
1922764Atrial Fibrillation Betapace 160 MG Oral TabletSYafce2787-8899-4098-87c8-f1e8dd19e6dd6
1922766Atrial Fibrillation Betapace 80 MG Oral TabletSYafce2787-8899-4098-87c8-f1e8dd19e6dd6
1923423Betapace 120 MG Oral TabletSYafce2787-8899-4098-87c8-f1e8dd19e6dd6
1923425Betapace 160 MG Oral TabletSYafce2787-8899-4098-87c8-f1e8dd19e6dd6
1923427Betapace 80 MG Oral TabletSYafce2787-8899-4098-87c8-f1e8dd19e6dd6
1922721Betapace AF 120 MG Oral TabletSYafce2787-8899-4098-87c8-f1e8dd19e6dd6
1922764Betapace AF 160 MG Oral TabletSYafce2787-8899-4098-87c8-f1e8dd19e6dd6
1922766Betapace AF 80 MG Oral TabletSYafce2787-8899-4098-87c8-f1e8dd19e6dd6
1922763sotalol HCl AF 160 MG Oral TabletSYafce2787-8899-4098-87c8-f1e8dd19e6dd6
1922765sotalol HCl AF 80 MG Oral TabletSYafce2787-8899-4098-87c8-f1e8dd19e6dd6
1922720sotalol hydrochloride AF 120 MG Oral TabletSYafce2787-8899-4098-87c8-f1e8dd19e6dd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70515-109-1070515010910100 TABLET in 1 BOTTLE (70515-109-10) 100 tablet2016-09-010000-00-00NoNoCurrent