FDA.reportPublic FDA data

Sotalol Hydrochloride

Product NDC
68084-654
11-digit product format
680840654
Labeler code
68084
Product ID
68084-654_52434622-ecc0-73e1-e063-6294a90a0859
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA076140
Marketing category
ANDA
Marketing start
2014-03-11
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
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 HYDROCHLORIDE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHEC37C70XX
Rxcui1923426

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
68084-654-01Sotalol Hydrochloride100 in 1 BOX, UNIT-DOSETABLET1009
68084-654-11Sotalol Hydrochloride1 in 1 BLISTER PACKTABLET19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-654-01EA - Each68084-6545e6677c9-1e8f-42c4-96a1-5be04a9ab4fb12014-04-03
68084-654-11EA - Each68084-654ba89d6d0-3127-4f5c-86e7-e8a38dda7e4d12014-04-03

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-654SOTALOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]8Current NDC, Legacy NDC, 2 package rows20240522_4614480b-b36e-4dbd-9fc0-d083890d297d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923426sotalol HCl 80 MG Oral TabletPSN4614480b-b36e-4dbd-9fc0-d083890d297d9
1923426sotalol hydrochloride 80 MG Oral TabletSCD4614480b-b36e-4dbd-9fc0-d083890d297d9
1923426sotalol HCl 80 MG Oral TabletPSN4f5902e1-9f9f-4c6b-817d-2efbb5e280616
1923426sotalol hydrochloride 80 MG Oral TabletSCD4f5902e1-9f9f-4c6b-817d-2efbb5e280616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-654-0168084065401100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-654-01) / 1 TABLET in 1 BLISTER PACK (68084-654-11) 100 blister pack2014-03-110000-00-00NoNoCurrent
68084-654-11680840654111 in 1 BLISTER PACKHistorical