FUROSEMIDE

Product NDC
61919-242
Requested package NDC
61919-242-30
11-digit product format
619190242
Labeler code
61919
Product ID
61919-242_eac39a9f-9e73-3866-e053-2a95a90a5768
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FUROSEMIDE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA077293
Marketing category
ANDA
Marketing start
2020-06-18
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, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded 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
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 · 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 UTC2026-02A077293-001FUROSEMIDE20MGTABLET / 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…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-098072bd15b7f6…

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 UTC2026-02A077293-001AB1011fe1cb6892…
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…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077293-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077293-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077293-001AB18072bd15b7f6…

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
9ec7808e-9201-4b8c-9790-d329320dc6c4Available 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
61919-242-302025-01-31C16284748780-11030e365-2e53-111a-e063-dadaa90a10e2FUROSEMIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-242-30FUROSEMIDE30 in 1 BOTTLETABLET306
61919-242-90FUROSEMIDE90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-242-30EA - Each61919-2422e7c51a4-82e8-4f81-a13e-a665c2e18a1712020-08-06
61919-242-90EA - Each61919-242bf147781-f020-4193-b4ee-47d640e8e3cf12026-03-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FUROSEMIDEACTIVE INGREDIENT7LXU5N7ZO5FUROSEMIDE TABLET [DIRECT RX]1
FUROSEMIDEACTIVE MOIETY7LXU5N7ZO5FUROSEMIDE TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFUROSEMIDE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FUROSEMIDE TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFUROSEMIDE TABLET [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UFUROSEMIDE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-242FUROSEMIDE TABLET [DIRECT RX]5Current NDC, Legacy NDC, 2 package rows20200626_9ec7808e-9201-4b8c-9790-d329320dc6c4.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
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
310429furosemide 20 MG Oral TabletPSN9ec7808e-9201-4b8c-9790-d329320dc6c46
310429furosemide 20 MG Oral TabletSCD9ec7808e-9201-4b8c-9790-d329320dc6c46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-242-306191902423030 TABLET in 1 BOTTLE (61919-242-30) 30 tablet2020-06-180000-00-00NoNoCurrent