Furosemide

Product NDC
68071-1809
11-digit product format
680711809
Labeler code
68071
Product ID
68071-1809_1d51781e-6c38-d57f-e063-6294a90a5ce2
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
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
2026-12-31
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
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Furosemide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FUROSEMIDE40 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
313988Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
809b4f68-4fca-c201-e053-2a91aa0ac18eAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-1809-12021-02-11C16284748780-1ba0f9c33-4dae-a910-e053-dadaa90a0b85Furosemide Tablets, USP
68071-1809-12021-01-29C16284748780-1ba0f9c33-4dae-a910-e053-dadaa90a0b85Furosemide Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1809-1Furosemide100 in 1 BOTTLETABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1809FUROSEMIDE (FUROSEMIDE) TABLET [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240716_809b4f68-4fca-c201-e053-2a91aa0ac18e.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.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
ndc (product): 68071-1809
FurosemideFUROSEMIDEAphena Pharma Solutions - Tennessee, LLC307c3b89-f37f-45ee-8ec7-d402008cf2fa2024-06-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313988furosemide 40 MG Oral TabletPSN809b4f68-4fca-c201-e053-2a91aa0ac18e4
313988furosemide 40 MG Oral TabletSCD809b4f68-4fca-c201-e053-2a91aa0ac18e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-1809-168071180901100 TABLET in 1 BOTTLE (68071-1809-1) 100 tablet2019-01-290000-00-00NoNoCurrent