Sotalol Hydrochloride

Product NDC
53217-011
11-digit product format
532170011
Labeler code
53217
Product ID
53217-011_909139f0-c2f9-4004-a245-b38cf54c4869
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076140
Marketing category
ANDA
Marketing start
2003-02-01
Marketing end
0000-00-00
Substance
SOTALOL HYDROCHLORIDE
Active strength
80 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-011-902020-01-31C16284748780-19d75b9d0-1e34-f424-e053-dadaa90a57ceSotalol Hydrochloride Tablets, USP 80 mg, 120 mg, 160 mg and 240 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-011-90Sotalol Hydrochloride90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-011-90EA - Each53217-011e6b4f5b5-a11c-4436-9bdb-d85486b4f84112015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SOTALOL HYDROCHLORIDEACTIVE INGREDIENTHEC37C70XXSOTALOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SOTALOLACTIVE MOIETYA6D97U294ISOTALOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USOTALOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SOTALOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-011SOTALOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140214_6481858a-353e-4b2a-af48-6c5d13ee0b2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923426sotalol HCl 80 MG Oral TabletPSN6481858a-353e-4b2a-af48-6c5d13ee0b2a1
1923426sotalol hydrochloride 80 MG Oral TabletSCD6481858a-353e-4b2a-af48-6c5d13ee0b2a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-011-905321700119090 in 1 BOTTLE, PLASTICHistorical