FDA.reportPublic FDA data

SOTALOL HYDROCHLORIDE

Product NDC
11788-053
11-digit product format
117880053
Labeler code
11788
Product ID
11788-053_d2c31b08-0c64-48be-aa84-aeaead306b2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SOTALOL HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
AiPing Pharmaceutical, Inc.
Application
ANDA075500
Marketing category
ANDA
Marketing start
2025-11-01
Substance
SOTALOL HYDROCHLORIDE
Active strength
160 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 HYDROCHLORIDE160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHEC37C70XX
Rxcui904589, 1923422, 1923424, 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
11788-053-01SOTALOL HYDROCHLORIDE100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11788-053-01EA - Each11788-053d35a2cf6-4615-4ae0-9c7a-75a2a40b828f12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923424sotalol HCl 160 MG Oral TabletPSNdb9b0b36-4c00-45b6-a50a-e08d7c61a17c100
1923424sotalol hydrochloride 160 MG Oral TabletSCDdb9b0b36-4c00-45b6-a50a-e08d7c61a17c100
1923422sotalol HCl 120 MG Oral TabletPSN56326224-fc80-4b89-8ba3-70cb873173b41
1923424sotalol HCl 160 MG Oral TabletPSN56326224-fc80-4b89-8ba3-70cb873173b41
904589sotalol HCl 240 MG Oral TabletPSN56326224-fc80-4b89-8ba3-70cb873173b41
1923426sotalol HCl 80 MG Oral TabletPSN56326224-fc80-4b89-8ba3-70cb873173b41
1923422sotalol hydrochloride 120 MG Oral TabletSCD56326224-fc80-4b89-8ba3-70cb873173b41
1923424sotalol hydrochloride 160 MG Oral TabletSCD56326224-fc80-4b89-8ba3-70cb873173b41
904589sotalol hydrochloride 240 MG Oral TabletSCD56326224-fc80-4b89-8ba3-70cb873173b41
1923426sotalol hydrochloride 80 MG Oral TabletSCD56326224-fc80-4b89-8ba3-70cb873173b41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11788-053-0111788005301100 TABLET in 1 BOTTLE (11788-053-01) 100 tablet2025-11-01NoNoHistorical