FDA.reportPublic FDA data

Sotalol Hydrochloride

Product NDC
71205-046
11-digit product format
712050046
Labeler code
71205
Product ID
71205-046_8fd472ad-bdc0-4672-b67c-658ce12aafc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075429
Marketing category
ANDA
Marketing start
2000-05-04
Substance
SOTALOL HYDROCHLORIDE
Active strength
80 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
Sotalol Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOTALOL HYDROCHLORIDE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHEC37C70XX
Rxcui1923426

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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
71205-046-30Sotalol Hydrochloride30 in 1 BOTTLETABLET305
71205-046-60Sotalol Hydrochloride60 in 1 BOTTLETABLET605
71205-046-90Sotalol Hydrochloride90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-046-30EA - Each71205-046394380f5-b7da-4409-82ec-181ef246e6ee12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-046SOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20241024_6acf10b5-bbd9-4993-99a9-2cdb8cec96c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923426sotalol HCl 80 MG Oral TabletPSN6acf10b5-bbd9-4993-99a9-2cdb8cec96c55
1923426sotalol hydrochloride 80 MG Oral TabletSCD6acf10b5-bbd9-4993-99a9-2cdb8cec96c55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-046-307120500463030 TABLET in 1 BOTTLE (71205-046-30) 30 tablet2018-06-010000-00-00NoNoCurrent
71205-046-607120500466060 TABLET in 1 BOTTLE (71205-046-60) 60 tablet2018-06-010000-00-00NoNoCurrent
71205-046-907120500469090 TABLET in 1 BOTTLE (71205-046-90) 90 tablet2018-06-010000-00-00NoNoCurrent