Furosemide

Product NDC
68071-3194
11-digit product format
680713194
Labeler code
68071
Product ID
68071-3194_bb144a40-46da-4c61-e053-2995a90a1206
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077293
Marketing category
ANDA
Marketing start
2006-02-01
Marketing end
0000-00-00
Substance
FUROSEMIDE
Active strength
20 mg/1
Pharmacologic classes
Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-3194DDiscontinued by firm2026-08-17
excluded packagepackage68071-319468071-3194-3DDiscontinued by firm2026-08-17
excluded packagepackage68071-319468071-3194-9DDiscontinued by firm2026-08-17

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 · 27 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-3194-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-3194-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-3194-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-3194-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-3194-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-3194-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-3194-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-3194-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-3194-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-3194-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-3194-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-3194-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-3194-9302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-3194-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-3194-9ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-3194-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-3194-90efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-3194-30efc9e666f02…f202fb6c5f17…

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
A077293-001FUROSEMIDEFUROSEMIDE20MGTABLET / ORALAB2005-11-09
A077293-002FUROSEMIDEFUROSEMIDE40MGTABLET / ORALAB2005-11-09
A077293-003FUROSEMIDEFUROSEMIDE80MGTABLET / ORALAB2005-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077293-001AB
A077293-002AB
A077293-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-09caaa826d4ba7…
2026-08-18 06:07:402026-07A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-09caaa826d4ba7…
2026-08-18 06:07:402026-07A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-091e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077293-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077293-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077293-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077293-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077293-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077293-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077293-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077293-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077293-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077293-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077293-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077293-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077293-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077293-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077293-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077293-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077293-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077293-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077293-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077293-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077293-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077293-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077293-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077293-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077293-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077293-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077293-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077293-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077293-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077293-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077293-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077293-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077293-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077293-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077293-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077293-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077293-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077293-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077293-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077293-001AB11e350fbaab3a…

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-08-23Furosemide Tablets, USP
2023-01-30Furosemide Tablets, USP
2021-02-11Furosemide Tablets, USP
2021-01-29Furosemide Tablets, USP

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.7cdcd001-ab4b-4210-a455-2e17a7bc49722026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDEREMEDYREPACK INC.916de29e-228c-4dfc-bcee-ad9a641316bd2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDEREMEDYREPACK INC.571a52ed-5258-46d5-a0d2-9a984cf738952026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDEUnit Dose Solutions, Inc.54dd664a-c7ec-27f3-e063-6294a90aff9f2026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDECoupler LLC53e58232-f7f9-c09b-e063-6394a90a5bc42026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDEPreferred Pharmaceuticals, Inc.a23fc1e0-2d16-43a8-a34e-f6505dcd63162026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDEPreferred Pharmaceuticals Inc.cad102d7-0197-4cff-bb80-9f0b5bcb599b2026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDEDirect_Rxe9be5c3b-4b18-7ad2-e053-2995a90a4a8b2026-03-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FUROSEMIDEFUROSEMIDENorthwind Health Company, LLC1d99e151-75ba-6a75-e063-6294a90a43602026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDEQPharma Inc341e29d9-a6f1-4c77-ae44-9b2c423ea6b42025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDEPD-Rx Pharmaceuticals, Inc.7842eeab-decf-47e7-9134-0add90549a3d2025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDEPD-Rx Pharmaceuticals, Inc.e20257f6-7cfe-43fa-a672-cc1cb312b83a2025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDEAphena Pharma Solutions - Tennessee, LLC3f6529fb-1173-ada3-e063-6294a90a76cb2025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDEProficient Rx LP600ca175-be2b-4c43-b119-133ae21a56012025-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDECoupler LLC33ec71e2-8fbd-0703-e063-6294a90a62e12025-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDENuCare Pharmaceuticals,Inc.809d9734-12dd-3b1f-e053-2a91aa0aadee2025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDENuCare Pharmaceuticals,Inc.813c8e9b-61bc-27c4-e053-2a91aa0a9f452024-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDEBryant Ranch Prepack0dd28e18-2e15-45eb-9a61-a9de7bd7d64e2024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDENuCare Pharmaceuticals,Inc.809b4f68-4fca-c201-e053-2a91aa0ac18e2024-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDEAphena Pharma Solutions - Tennessee, LLC307c3b89-f37f-45ee-8ec7-d402008cf2fa2024-06-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3194-96807131940990 TABLET in 1 BOTTLE (68071-3194-9) 90 tablet2019-01-290000-00-00NoNoCurrent