FDA.reportPublic FDA data

Torsemide

Product NDC
23155-871
11-digit product format
231550871
Labeler code
23155
Product ID
23155-871_98d688f8-ec71-4b98-86b8-d405bdffc4c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Torsemide
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA076894
Marketing category
ANDA
Marketing start
2023-07-24
Substance
TORSEMIDE
Active strength
5 mg/1
Pharmacologic classes
Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Torsemide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TORSEMIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW31X2H97FB
Rxcui198369, 198370, 198371, 198372

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
23155-871-01Torsemide100 in 1 BOTTLETABLET1001
23155-871-05Torsemide500 in 1 BOTTLETABLET5001
23155-871-10Torsemide1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-871-01EA - Each23155-8714bcc9d19-f304-4eb9-bd49-e57a872fc5e312023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-871TORSEMIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]1Current NDC, 3 package rows20230724_03fbbb85-4e0f-4f3b-b4b0-87f84cb33d47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198369torsemide 10 MG Oral TabletPSN03fbbb85-4e0f-4f3b-b4b0-87f84cb33d471
198369torsemide 10 MG Oral TabletPSN2411e6f8-4fc3-f986-e063-6294a90a055a1
198370torsemide 100 MG Oral TabletPSN03fbbb85-4e0f-4f3b-b4b0-87f84cb33d471
198370torsemide 100 MG Oral TabletPSN2411e6f8-4fc3-f986-e063-6294a90a055a1
198371torsemide 20 MG Oral TabletPSN03fbbb85-4e0f-4f3b-b4b0-87f84cb33d471
198372torsemide 5 MG Oral TabletPSN03fbbb85-4e0f-4f3b-b4b0-87f84cb33d471
198372torsemide 5 MG Oral TabletPSN2411e6f8-4fc3-f986-e063-6294a90a055a1
198369torsemide 10 MG Oral TabletSCD03fbbb85-4e0f-4f3b-b4b0-87f84cb33d471
198369torsemide 10 MG Oral TabletSCD2411e6f8-4fc3-f986-e063-6294a90a055a1
198370torsemide 100 MG Oral TabletSCD03fbbb85-4e0f-4f3b-b4b0-87f84cb33d471
198370torsemide 100 MG Oral TabletSCD2411e6f8-4fc3-f986-e063-6294a90a055a1
198371torsemide 20 MG Oral TabletSCD03fbbb85-4e0f-4f3b-b4b0-87f84cb33d471
198372torsemide 5 MG Oral TabletSCD03fbbb85-4e0f-4f3b-b4b0-87f84cb33d471
198372torsemide 5 MG Oral TabletSCD2411e6f8-4fc3-f986-e063-6294a90a055a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23155-871-0123155087101100 TABLET in 1 BOTTLE (23155-871-01) 100 tablet2023-07-24NoNoHistorical
23155-871-0523155087105500 TABLET in 1 BOTTLE (23155-871-05) 500 tablet2023-07-24NoNoHistorical
23155-871-10231550871101000 TABLET in 1 BOTTLE (23155-871-10) 1000 tablet2023-07-24NoNoHistorical