Furosemide

Product NDC
70518-3061
Requested package NDC
70518-3061-2
11-digit product format
705183061
Labeler code
70518
Product ID
70518-3061_56aaba60-5240-6ac7-e063-6394a90a2756
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
furosemide
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076796
Marketing category
ANDA
Marketing start
2021-03-31
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
2027-12-31
Current FDA listing
Yes

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 · 9 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…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-2684e616aacf4f…
2026-08-18 06:07:402026-07A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-26caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076796-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A076796-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A076796-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A076796-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076796-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076796-003AB1caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Furosemide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FUROSEMIDE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7LXU5N7ZO5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310429Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3d312ab0-589c-427b-84da-18887244bfc9Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3061-0Furosemide5 in 1 BOTTLE, PLASTICTABLET513
70518-3061-1Furosemide30 in 1 BLISTER PACKTABLET3013
70518-3061-2Furosemide30 in 1 BLISTER PACKTABLET3013
70518-3061-3Furosemide30 in 1 BOTTLE, PLASTICTABLET3013
70518-3061-4Furosemide14 in 1 BOTTLE, PLASTICTABLET1413
70518-3061-5Furosemide7 in 1 BOTTLE, PLASTICTABLET713
70518-3061-6Furosemide50 in 1 BOXTABLET5013
70518-3061-7Furosemide1 in 1 POUCHTABLET113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3061FUROSEMIDE TABLET [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 8 package rows20250104_3d312ab0-589c-427b-84da-18887244bfc9.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
ndc (package): 70518-3061-2
ndc (product): 70518-3061
ndc11 (package): 70518306102
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 TabletPSN3d312ab0-589c-427b-84da-18887244bfc913
310429furosemide 20 MG Oral TabletSCD3d312ab0-589c-427b-84da-18887244bfc913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3061-27051830610230 TABLET in 1 BLISTER PACK (70518-3061-2) 30 tablet2023-11-29NoNoCurrent