FDA.reportPublic FDA data

SOAANZ

Product NDC
73502-586
11-digit product format
735020586
Labeler code
73502
Product ID
73502-586_47fa8bbb-4c81-97c3-e063-6394a90a61cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Torsemide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sarfez Pharmaceuticals Inc
Application
NDA213218
Marketing category
NDA
Marketing start
2022-01-24
Substance
TORSEMIDE
Active strength
40 mg/1
Pharmacologic classes
Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SOAANZ
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TORSEMIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW31X2H97FB
Rxcui198371, 2589877, 2589881, 2589883, 2589885, 2589887

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4be7e40e-4a67-4791-ac86-36ee792616f1Product name120220118
71194f54-ef13-d3b7-9576-5c094148f9c1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73502-586-10SOAANZ30 in 1 BOTTLETABLET, FILM COATED304
73502-586-11SOAANZ90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73502-586SOAANZ (TORSEMIDE) TABLET, FILM COATED [SARFEZ PHARMACEUTICALS INC]3Current NDC, Legacy NDC, 2 package rows20240119_05eaa163-b6e9-438a-85f8-6a60e743d460.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2589877SOAANZ 20 MG Oral TabletPSN05eaa163-b6e9-438a-85f8-6a60e743d4604
2589883SOAANZ 40 MG Oral TabletPSN05eaa163-b6e9-438a-85f8-6a60e743d4604
2589887SOAANZ 60 MG Oral TabletPSN05eaa163-b6e9-438a-85f8-6a60e743d4604
198371torsemide 20 MG Oral TabletPSN05eaa163-b6e9-438a-85f8-6a60e743d4604
2589881torsemide 40 MG Oral TabletPSN05eaa163-b6e9-438a-85f8-6a60e743d4604
2589885torsemide 60 MG Oral TabletPSN05eaa163-b6e9-438a-85f8-6a60e743d4604
2589877torsemide 20 MG Oral Tablet [Soaanz]SBD05eaa163-b6e9-438a-85f8-6a60e743d4604
2589883torsemide 40 MG Oral Tablet [Soaanz]SBD05eaa163-b6e9-438a-85f8-6a60e743d4604
2589887torsemide 60 MG Oral Tablet [Soaanz]SBD05eaa163-b6e9-438a-85f8-6a60e743d4604
198371torsemide 20 MG Oral TabletSCD05eaa163-b6e9-438a-85f8-6a60e743d4604
2589881torsemide 40 MG Oral TabletSCD05eaa163-b6e9-438a-85f8-6a60e743d4604
2589885torsemide 60 MG Oral TabletSCD05eaa163-b6e9-438a-85f8-6a60e743d4604
2589877Soaanz 20 MG Oral TabletSY05eaa163-b6e9-438a-85f8-6a60e743d4604
2589883Soaanz 40 MG Oral TabletSY05eaa163-b6e9-438a-85f8-6a60e743d4604
2589887Soaanz 60 MG Oral TabletSY05eaa163-b6e9-438a-85f8-6a60e743d4604

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
73502-586-107350205861030 TABLET, FILM COATED in 1 BOTTLE (73502-586-10) 2022-01-240000-00-00NoNoCurrent
73502-586-117350205861190 TABLET, FILM COATED in 1 BOTTLE (73502-586-11) 2022-01-240000-00-00NoNoCurrent