Furosemide

Product NDC
53808-1109
Requested package NDC
53808-1109-1
11-digit product format
538081109
Labeler code
53808
Product ID
53808-1109_0349dc51-00b4-4f90-ba8d-0590a7098610
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
furosemide
Dosage form
TABLET
Route
ORAL
Labeler
DOH CENTRAL PHARMACY
Application
ANDA076796
Marketing category
ANDA
Marketing start
2018-04-25
Marketing end
0000-00-00
Substance
FUROSEMIDE
Active strength
40 mg/1
Pharmacologic classes
Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53808-110953808-1109-1IInactivated by FDA2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A076796-001FUROSEMIDEFUROSEMIDE20MGTABLET / ORALAB2004-03-26
A076796-002FUROSEMIDEFUROSEMIDE40MGTABLET / ORALAB2004-03-26
A076796-003FUROSEMIDEFUROSEMIDE80MGTABLET / ORALAB2004-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A076796-001AB
A076796-002AB
A076796-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-268072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076796-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076796-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076796-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076796-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076796-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076796-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076796-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076796-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076796-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076796-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076796-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076796-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076796-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076796-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076796-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076796-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076796-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076796-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076796-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076796-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076796-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076796-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076796-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076796-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076796-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076796-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076796-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076796-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076796-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076796-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076796-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076796-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076796-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076796-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076796-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076796-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076796-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076796-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076796-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076796-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d80d3aff-3a63-4d7b-a2be-fd9388b04330Product name920250806
9061e89f-9c86-4196-b34b-886fc1673cc4Product name120140821

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-1109-12024-01-30C16284748780-11030e365-0cf5-111a-e063-dadaa90a10e2FUROSEMIDE TABLETS, USP 20, 40, and 80 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-1109-1Furosemide30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1109FUROSEMIDE TABLET [DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20190118_2e9928cb-0105-4552-9d41-260de8934a64.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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FurosemideFUROSEMIDEREMEDYREPACK INC.3d312ab0-589c-427b-84da-18887244bfc92026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDECardinal Health 107, LLC2a5bcf50-6d63-463a-915e-a72ea2e5f1312026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDEMajor Pharmaceuticals6be1addd-a811-47fc-8650-6870d661c2342026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDEREMEDYREPACK INC.7181e528-c862-4dd7-8446-9011e4c7312a2026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDENuCare Pharmaceuticals,Inc.bd45c963-a413-e9a1-e053-2a95a90a14382026-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDEAvKAREd4c532be-1f3f-60d3-e053-2995a90a98be2026-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDENorthwind Health Company, LLCf2b920b2-f8b3-1e6e-e053-2a95a90ae1532026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDEPD-Rx Pharmaceuticals, Inc.48d8f490-e9d1-4c95-ab2f-414d3f4a9df42025-08-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDEPD-Rx Pharmaceuticals, Inc.c24489c3-65e0-44e3-a50a-8bb0672e88212025-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDEPD-Rx Pharmaceuticals, Inc.52e75604-5766-40e8-a13a-8c449e06ebda2025-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDEPD-Rx Pharmaceuticals, Inc.12137a90-fb35-45d7-8984-0b04793d3e342025-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDEPD-Rx Pharmaceuticals, Inc.3ba730ab-90d4-478a-80b3-1ea3edb03e4d2025-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDESolco Healthcare LLC6a0fb397-63ae-4fce-bddf-16a91b1b7a2f2025-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDENCS HealthCare of KY, LLC dba Vangard Labs114f4f4f-536a-4658-8fd0-2dd8c029b19a2024-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDEBryant Ranch Prepack25c0aded-ffcd-4145-a48c-76c5fb220f612024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDENuCare Pharmaceuticals,Inc.6cbf3834-0433-4dc0-e053-2a91aa0a8f8a2024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDENuCare Pharmaceuticals,Inc.7316929d-413a-e78f-e053-2a91aa0a417e2024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDENuCare Pharmaceuticals,Inc.73e5c8f3-32f8-114c-e053-2a91aa0ab5002024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDEAphena Pharma Solutions - Tennessee, LLC4b3e2e13-a657-4da5-b536-8ae0a26812e02024-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDEBryant Ranch Prepack3b028a3c-102a-40f1-820e-b187ff1e18032024-03-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313988furosemide 40 MG Oral TabletPSN2e9928cb-0105-4552-9d41-260de8934a641
313988furosemide 40 MG Oral TabletSCD2e9928cb-0105-4552-9d41-260de8934a641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53808-1109-15380811090130 TABLET in 1 BLISTER PACK (53808-1109-1) 30 tablet2018-04-250000-00-00NoNoCurrent