Furosemide

Product NDC
68071-2313
11-digit product format
680712313
Labeler code
68071
Product ID
68071-2313_d775c43c-2c40-586b-e053-2a95a90a0b35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
furosemide
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA076796
Marketing category
ANDA
Marketing start
2004-03-26
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
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-2313IInactivated by FDA2026-08-10
excluded packagepackage68071-231368071-2313-3IInactivated 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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-2313-3IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-2313-3IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-2313-3IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-2313-3IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-2313-3IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-2313-3IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2313-3UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2313-3UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2313-3UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2313-3Furosemide30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2313FUROSEMIDE TABLET [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20220208_b623c3b3-3e25-67f0-e053-2a95a90a297c.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
310429furosemide 20 MG Oral TabletPSNb623c3b3-3e25-67f0-e053-2a95a90a297c2
310429furosemide 20 MG Oral TabletSCDb623c3b3-3e25-67f0-e053-2a95a90a297c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2313-36807123130330 TABLET in 1 BOTTLE, PLASTIC (68071-2313-3) 30 tablet2020-12-100000-00-00NoNoCurrent