Furosemide

Product NDC
17856-3298
11-digit product format
178563298
Labeler code
17856
Product ID
17856-3298_19cdde0c-a4f5-47a1-bda1-f4cf9eca53b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide
Dosage form
SOLUTION
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
ANDA070433
Marketing category
ANDA
Marketing start
1987-04-22
Marketing end
0000-00-00
Substance
FUROSEMIDE
Active strength
40 mg/5mL
Pharmacologic classes
Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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 · 44 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 packagepackage17856-3298-1IInactivated 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 packagepackage17856-3298-1IInactivated 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 packagepackage17856-3298-1IInactivated 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 packagepackage17856-3298-1IInactivated 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 packagepackage17856-3298-1IInactivated 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 packagepackage17856-3298-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-3298-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-3298-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-3298-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17856-3298-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17856-3298-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17856-3298-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage17856-3298-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage17856-3298-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-3298-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage17856-3298-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage17856-3298-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage17856-3298-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage17856-3298-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage17856-3298-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage17856-3298-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage17856-3298-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070433-001FUROSEMIDEFUROSEMIDE40MG/5MLSOLUTION / ORALRS1987-04-22

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORALRS1987-04-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORALRS1987-04-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-223f01610625f2…
2019-09-15 20:21 UTC2019-09A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070433-001FUROSEMIDE40MG/5MLSOLUTION / ORAL1987-04-22e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FUROSEMIDE40 mg/5mL

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
197731Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9c342198-7162-4cc5-bda1-bc4054a4292bAvailable 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
17856-3298-12020-01-31C16284748780-19d75b9d1-1cd7-f424-e053-dadaa90a57ce9c342198-7162-4cc5-bda1-bc4054a4292b
17856-3298-12020-01-31C16284748780-19d75b9d1-1cd7-f424-e053-dadaa90a57ceFurosemide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-3298-1Furosemide5 mL in 1 CUPSOLUTION53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-3298FUROSEMIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3Legacy NDC, 1 package rows20160511_9c342198-7162-4cc5-bda1-bc4054a4292b.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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FurosemideFUROSEMIDEAtlantic Biologicals Corps9c342198-7162-4cc5-bda1-bc4054a4292b2026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070433
application number: ANDA070433
ndc (product): 17856-3298
FurosemideFUROSEMIDEHikma Pharmaceuticals USA Inc.9e493331-dddd-496e-abf8-61747fb67aba2025-11-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070433
application number: ANDA070433
FurosemideFUROSEMIDEPrecision Dose Inc.3fd02fb5-98a0-4eda-a0ec-41faabe047062024-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070433
application number: ANDA070433

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197731furosemide 40 MG in 5 mL Oral SolutionPSN9c342198-7162-4cc5-bda1-bc4054a4292b3
197731furosemide 8 MG/ML Oral SolutionSCD9c342198-7162-4cc5-bda1-bc4054a4292b3
197731furosemide 40 MG per 5 ML Oral SolutionSY9c342198-7162-4cc5-bda1-bc4054a4292b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
17856-3298-1178563298015 mL in 1 CUP (17856-3298-1)5 ml2016-05-100Current