FDA.reportPublic FDA data

BETAPACE AF

Product NDC
83107-009
11-digit product format
831070009
Labeler code
83107
Product ID
83107-009_fcc2fc9c-87b2-4f9f-8d4d-b1f10214884e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sotalol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Legacy Pharma USA, Inc.
Application
NDA019865
Marketing category
NDA
Marketing start
2016-09-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BETAPACE AF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOTALOL HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHEC37C70XX
Rxcui1922720, 1922721, 1922763, 1922764, 1922765, 1922766, 1923422, 1923423, 1923424, 1923425, 1923426, 1923427

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
83107-009-60BETAPACE AF60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83107-009BETAPACE (SOTALOL HYDROCHLORIDE) TABLET BETAPACE AF (SOTALOL HYDROCHLORIDE) TABLET [LEGACY PHARMA USA, INC.]2Current NDC, 1 package rows20241220_a6a7702f-36c9-45db-b640-453dc324baee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923423Betapace 120 MG Oral TabletPSNa6a7702f-36c9-45db-b640-453dc324baee2
1923425Betapace 160 MG Oral TabletPSNa6a7702f-36c9-45db-b640-453dc324baee2
1923427Betapace 80 MG Oral TabletPSNa6a7702f-36c9-45db-b640-453dc324baee2
1922721Betapace AF 120 MG Oral TabletPSNa6a7702f-36c9-45db-b640-453dc324baee2
1922764Betapace AF 160 MG Oral TabletPSNa6a7702f-36c9-45db-b640-453dc324baee2
1922766Betapace AF 80 MG Oral TabletPSNa6a7702f-36c9-45db-b640-453dc324baee2
1923422sotalol HCl 120 MG Oral TabletPSNa6a7702f-36c9-45db-b640-453dc324baee2
1923424sotalol HCl 160 MG Oral TabletPSNa6a7702f-36c9-45db-b640-453dc324baee2
1923426sotalol HCl 80 MG Oral TabletPSNa6a7702f-36c9-45db-b640-453dc324baee2
1922720sotalol HCl AF 120 MG Oral TabletPSNa6a7702f-36c9-45db-b640-453dc324baee2
1922763sotalol HCl AF 160 MG Oral TabletPSNa6a7702f-36c9-45db-b640-453dc324baee2
1922765sotalol HCl AF 80 MG Oral TabletPSNa6a7702f-36c9-45db-b640-453dc324baee2
1922721Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet [Betapace]SBDa6a7702f-36c9-45db-b640-453dc324baee2
1922764Atrial Fibrillation sotalol hydrochloride 160 MG Oral Tablet [Betapace]SBDa6a7702f-36c9-45db-b640-453dc324baee2
1922766Atrial Fibrillation sotalol hydrochloride 80 MG Oral Tablet [Betapace]SBDa6a7702f-36c9-45db-b640-453dc324baee2
1923423sotalol hydrochloride 120 MG Oral Tablet [Betapace]SBDa6a7702f-36c9-45db-b640-453dc324baee2
1923425sotalol hydrochloride 160 MG Oral Tablet [Betapace]SBDa6a7702f-36c9-45db-b640-453dc324baee2
1923427sotalol hydrochloride 80 MG Oral Tablet [Betapace]SBDa6a7702f-36c9-45db-b640-453dc324baee2
1922720Atrial Fibrillation sotalol hydrochloride 120 MG Oral TabletSCDa6a7702f-36c9-45db-b640-453dc324baee2
1922763Atrial Fibrillation sotalol hydrochloride 160 MG Oral TabletSCDa6a7702f-36c9-45db-b640-453dc324baee2
1922765Atrial Fibrillation sotalol hydrochloride 80 MG Oral TabletSCDa6a7702f-36c9-45db-b640-453dc324baee2
1923422sotalol hydrochloride 120 MG Oral TabletSCDa6a7702f-36c9-45db-b640-453dc324baee2
1923424sotalol hydrochloride 160 MG Oral TabletSCDa6a7702f-36c9-45db-b640-453dc324baee2
1923426sotalol hydrochloride 80 MG Oral TabletSCDa6a7702f-36c9-45db-b640-453dc324baee2
1922721Atrial Fibrillation Betapace 120 MG Oral TabletSYa6a7702f-36c9-45db-b640-453dc324baee2
1922764Atrial Fibrillation Betapace 160 MG Oral TabletSYa6a7702f-36c9-45db-b640-453dc324baee2
1922766Atrial Fibrillation Betapace 80 MG Oral TabletSYa6a7702f-36c9-45db-b640-453dc324baee2
1923423Betapace 120 MG Oral TabletSYa6a7702f-36c9-45db-b640-453dc324baee2
1923425Betapace 160 MG Oral TabletSYa6a7702f-36c9-45db-b640-453dc324baee2
1923427Betapace 80 MG Oral TabletSYa6a7702f-36c9-45db-b640-453dc324baee2
1922721Betapace AF 120 MG Oral TabletSYa6a7702f-36c9-45db-b640-453dc324baee2
1922764Betapace AF 160 MG Oral TabletSYa6a7702f-36c9-45db-b640-453dc324baee2
1922766Betapace AF 80 MG Oral TabletSYa6a7702f-36c9-45db-b640-453dc324baee2
1922763sotalol HCl AF 160 MG Oral TabletSYa6a7702f-36c9-45db-b640-453dc324baee2
1922765sotalol HCl AF 80 MG Oral TabletSYa6a7702f-36c9-45db-b640-453dc324baee2
1922720sotalol hydrochloride AF 120 MG Oral TabletSYa6a7702f-36c9-45db-b640-453dc324baee2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83107-009-608310700096060 TABLET in 1 BOTTLE (83107-009-60) 60 tablet2016-09-01NoNoCurrent