sotalol hydrochloride

Product NDC
0185-0177
11-digit product format
001850177
Labeler code
0185
Product ID
0185-0177_401b80f7-8916-4421-be5f-e0647f553c88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sotalol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Eon Labs, Inc.
Application
ANDA075366
Marketing category
ANDA
Marketing start
2000-05-01
Marketing end
0000-00-00
Substance
SOTALOL HYDROCHLORIDE
Active strength
160 mg/1
Pharmacologic classes
Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-0177-01EA - Each0185-0177c1bca7d9-8eaa-44b8-9271-a7a1ac10617912012-07-24
0185-0177-09EA - Each0185-01773f6e0324-49f2-409f-90de-76fa1c676b9012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SOTALOL HYDROCHLORIDEACTIVE INGREDIENTHEC37C70XXSOTALOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SOTALOLACTIVE MOIETYA6D97U294ISOTALOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSOTALOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSOTALOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSOTALOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSOTALOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SOTALOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SOTALOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SOTALOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923422sotalol HCl 120 MG Oral TabletPSN1436950d-a07f-43bb-811f-201f2991dbf61
1923424sotalol HCl 160 MG Oral TabletPSN1436950d-a07f-43bb-811f-201f2991dbf61
1923426sotalol HCl 80 MG Oral TabletPSN1436950d-a07f-43bb-811f-201f2991dbf61
1923422sotalol hydrochloride 120 MG Oral TabletSCD1436950d-a07f-43bb-811f-201f2991dbf61
1923424sotalol hydrochloride 160 MG Oral TabletSCD1436950d-a07f-43bb-811f-201f2991dbf61
1923426sotalol hydrochloride 80 MG Oral TabletSCD1436950d-a07f-43bb-811f-201f2991dbf61