FDA.reportPublic FDA data

Sotalol Hydrochloride

Product NDC
50268-725
11-digit product format
502680725
Labeler code
50268
Product ID
50268-725_47fc0908-1c7a-abc6-e063-6294a90a20b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA076140
Marketing category
ANDA
Marketing start
2021-03-04
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sotalol Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOTALOL HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHEC37C70XX
Rxcui1923422, 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
50268-725-11Sotalol Hydrochloride1 in 1 BLISTER PACKTABLET13
50268-725-15Sotalol Hydrochloride50 in 1 BOXTABLET503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-725-11EA - Each50268-725835612c6-92b8-4a46-920c-3274d87f5c4b12021-04-08
50268-725-15EA - Each50268-725fbcae383-9e0f-407a-928f-7b5250356fc112021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-725SOTALOL HYDROCHLORIDE TABLET [AVPAK]2Current NDC, Legacy NDC, 2 package rows20221116_bcbc1624-283e-732f-e053-2995a90a8f11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923422sotalol HCl 120 MG Oral TabletPSNbcbc1624-283e-732f-e053-2995a90a8f113
1923426sotalol HCl 80 MG Oral TabletPSNbcbc1624-283e-732f-e053-2995a90a8f113
1923422sotalol hydrochloride 120 MG Oral TabletSCDbcbc1624-283e-732f-e053-2995a90a8f113
1923426sotalol hydrochloride 80 MG Oral TabletSCDbcbc1624-283e-732f-e053-2995a90a8f113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-725-11502680725111 in 1 BLISTER PACKHistorical
50268-725-155026807251550 BLISTER PACK in 1 BOX (50268-725-15) / 1 TABLET in 1 BLISTER PACK (50268-725-11) 50 blister pack2021-03-040000-00-00NoNoCurrent