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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N213218-001SOAANZTORSEMIDE20MGTABLET / ORALRLD2021-06-14
N213218-002SOAANZTORSEMIDE60MGTABLET / ORALRLD2021-06-14
N213218-003SOAANZTORSEMIDE40MGTABLET / ORALRLD2021-11-17

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N213218-001101549632033-10-06Drug product2021-09-07
N213218-002101549632033-10-06Drug product2021-09-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N213218-001SOAANZ20MGTABLET / ORALRLD2021-06-14caaa826d4ba7…
2026-08-18 06:07:402026-07N213218-002SOAANZ60MGTABLET / ORALRLD2021-06-14caaa826d4ba7…
2026-08-18 06:07:402026-07N213218-003SOAANZ40MGTABLET / ORALRLD2021-11-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N213218-001SOAANZ20MGTABLET / ORALRLD2021-06-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213218-002SOAANZ60MGTABLET / ORALRLD2021-06-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213218-003SOAANZ40MGTABLET / ORALRLD2021-11-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213218-001SOAANZ20MGTABLET / ORALRLD2021-06-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213218-002SOAANZ60MGTABLET / ORALRLD2021-06-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213218-003SOAANZ40MGTABLET / ORALRLD2021-11-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N213218-001SOAANZ20MGTABLET / ORALRLD2021-06-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213218-002SOAANZ60MGTABLET / ORALRLD2021-06-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213218-003SOAANZ40MGTABLET / ORALRLD2021-11-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213218-001SOAANZ20MGTABLET / ORALRLD2021-06-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213218-002SOAANZ60MGTABLET / ORALRLD2021-06-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213218-003SOAANZ40MGTABLET / ORALRLD2021-11-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213218-001SOAANZ20MGTABLET / ORALRLD2021-06-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213218-002SOAANZ60MGTABLET / ORALRLD2021-06-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213218-003SOAANZ40MGTABLET / ORALRLD2021-11-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213218-001SOAANZ20MGTABLET / ORALRLD2021-06-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213218-002SOAANZ60MGTABLET / ORALRLD2021-06-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213218-003SOAANZ40MGTABLET / ORALRLD2021-11-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213218-001SOAANZ20MGTABLET / ORALRLD2021-06-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213218-002SOAANZ60MGTABLET / ORALRLD2021-06-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213218-003SOAANZ40MGTABLET / ORALRLD2021-11-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213218-001SOAANZ20MGTABLET / ORALRLD2021-06-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213218-002SOAANZ60MGTABLET / ORALRLD2021-06-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213218-003SOAANZ40MGTABLET / ORALRLD2021-11-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213218-001SOAANZ20MGTABLET / ORALRLD2021-06-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213218-002SOAANZ60MGTABLET / ORALRLD2021-06-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213218-003SOAANZ40MGTABLET / ORALRLD2021-11-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N213218-001SOAANZ20MGTABLET / ORALRLD2021-06-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N213218-002SOAANZ60MGTABLET / ORALRLD2021-06-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N213218-003SOAANZ40MGTABLET / ORALRLD2021-11-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N213218-001SOAANZ20MGTABLET / ORALRLD2021-06-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N213218-002SOAANZ60MGTABLET / ORALRLD2021-06-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N213218-003SOAANZ40MGTABLET / ORALRLD2021-11-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N213218-001SOAANZ20MGTABLET / ORALRLD2021-06-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N213218-002SOAANZ60MGTABLET / ORALRLD2021-06-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N213218-003SOAANZ40MGTABLET / ORALRLD2021-11-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N213218-001SOAANZ20MGTABLET / ORALRLD2021-06-141e350fbaab3a…

Observed Orange Book patent history#

Patent history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N213218-001101549632033-10-06Drug product2021-09-07caaa826d4ba7…
2026-08-18 06:07:402026-07N213218-002101549632033-10-06Drug product2021-09-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N213218-001101549632033-10-06Drug product2021-09-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213218-002101549632033-10-06Drug product2021-09-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213218-001101549632033-10-06Drug product2021-09-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213218-002101549632033-10-06Drug product2021-09-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N213218-001101549632033-10-06Drug product2021-09-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213218-002101549632033-10-06Drug product2021-09-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213218-001101549632033-10-06Drug product2021-09-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213218-002101549632033-10-06Drug product2021-09-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213218-001101549632033-10-06Drug product2021-09-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213218-002101549632033-10-06Drug product2021-09-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213218-001101549632033-10-06Drug product2021-09-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213218-002101549632033-10-06Drug product2021-09-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213218-001101549632033-10-06Drug product2021-09-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213218-002101549632033-10-06Drug product2021-09-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213218-001101549632033-10-06Drug product2021-09-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213218-002101549632033-10-06Drug product2021-09-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213218-001101549632033-10-06Drug product2021-09-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213218-002101549632033-10-06Drug product2021-09-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N213218-001101549632033-10-06Drug product2021-09-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N213218-002101549632033-10-06Drug product2021-09-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N213218-001101549632033-10-06Drug product2021-09-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N213218-002101549632033-10-06Drug product2021-09-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N213218-001101549632033-10-06Drug product2021-09-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N213218-002101549632033-10-06Drug product2021-09-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N213218-001101549632033-10-06Drug product2021-09-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N213218-002101549632033-10-06Drug product2021-09-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N213218-001101549632033-10-06Drug product2021-09-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05N213218-002101549632033-10-06Drug product2021-09-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N213218-001101549632033-10-06Drug product2021-09-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N213218-002101549632033-10-06Drug product2021-09-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N213218-001101549632033-10-06Drug product2021-09-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N213218-002101549632033-10-06Drug product2021-09-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N213218-001101549632033-10-06Drug product2021-09-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N213218-002101549632033-10-06Drug product2021-09-074b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N213218-001101549632033-10-06Drug product2021-09-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N213218-002101549632033-10-06Drug product2021-09-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N213218-001101549632033-10-06Drug product2021-09-07782e0a99824c…
2021-12-28 21:50 UTC2021-12N213218-002101549632033-10-06Drug product2021-09-07782e0a99824c…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W31X2H97FBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198371Internal RxNorm lookup
2589877Internal RxNorm lookup
2589881Internal RxNorm lookup
2589883Internal RxNorm lookup
2589885Internal RxNorm lookup
2589887Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
05eaa163-b6e9-438a-85f8-6a60e743d460Available on FDA.report

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73502-586-10EA - Each73502-58633a484d3-e998-432e-b132-5831ac365c7e12022-02-07
73502-586-11EA - Each73502-586c013addf-dc8b-4684-b1a9-590fe389607612022-02-07

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOAANZTORSEMIDESarfez Pharmaceuticals Inc05eaa163-b6e9-438a-85f8-6a60e743d4602026-01-09Exact identifier
application applno (NDA): 213218
application number: NDA213218
ndc (product): 73502-586

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