Furosemide

Product NDC
71610-308
Requested package NDC
71610-308-30
11-digit product format
716100308
Labeler code
71610
Product ID
71610-308_f0960a17-009b-4da4-b2cc-7851e22a2165
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA018823
Marketing category
NDA
Marketing start
1983-11-10
Marketing end
0000-00-00
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
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71610-30871610-308-30IInactivated by FDA2026-08-07

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 · 15 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…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018823-001FUROSEMIDEFUROSEMIDE20MGTABLET / ORALAB1983-11-10
N018823-002FUROSEMIDEFUROSEMIDE40MGTABLET / ORALAB1983-11-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N018823-001AB
N018823-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N018823-001FUROSEMIDE20MGTABLET / ORALAB1983-11-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018823-002FUROSEMIDE40MGTABLET / ORALAB1983-11-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018823-001FUROSEMIDE20MGTABLET / ORALAB1983-11-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018823-002FUROSEMIDE40MGTABLET / ORALAB1983-11-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N018823-001FUROSEMIDE20MGTABLET / ORALAB1983-11-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018823-002FUROSEMIDE40MGTABLET / ORALAB1983-11-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018823-001FUROSEMIDE20MGTABLET / ORALAB1983-11-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018823-002FUROSEMIDE40MGTABLET / ORALAB1983-11-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018823-001FUROSEMIDE20MGTABLET / ORALAB1983-11-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018823-002FUROSEMIDE40MGTABLET / ORALAB1983-11-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018823-001FUROSEMIDE20MGTABLET / ORALAB1983-11-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018823-002FUROSEMIDE40MGTABLET / ORALAB1983-11-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018823-001FUROSEMIDE20MGTABLET / ORALAB1983-11-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018823-002FUROSEMIDE40MGTABLET / ORALAB1983-11-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018823-001FUROSEMIDE20MGTABLET / ORALAB1983-11-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018823-002FUROSEMIDE40MGTABLET / ORALAB1983-11-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018823-001FUROSEMIDE20MGTABLET / ORALAB1983-11-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018823-002FUROSEMIDE40MGTABLET / ORALAB1983-11-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018823-001FUROSEMIDE20MGTABLET / ORALAB1983-11-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N018823-002FUROSEMIDE40MGTABLET / ORALAB1983-11-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018823-001FUROSEMIDE20MGTABLET / ORALAB1983-11-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018823-002FUROSEMIDE40MGTABLET / ORALAB1983-11-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018823-001FUROSEMIDE20MGTABLET / ORALAB1983-11-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018823-002FUROSEMIDE40MGTABLET / ORALAB1983-11-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018823-001FUROSEMIDE20MGTABLET / ORALAB1983-11-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018823-002FUROSEMIDE40MGTABLET / ORALAB1983-11-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018823-001FUROSEMIDE20MGTABLET / ORALAB1983-11-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018823-002FUROSEMIDE40MGTABLET / ORALAB1983-11-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018823-001FUROSEMIDE20MGTABLET / ORALAB1983-11-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018823-002FUROSEMIDE40MGTABLET / ORALAB1983-11-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018823-001FUROSEMIDE20MGTABLET / ORALAB1983-11-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018823-002FUROSEMIDE40MGTABLET / ORALAB1983-11-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018823-001FUROSEMIDE20MGTABLET / ORALAB1983-11-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018823-002FUROSEMIDE40MGTABLET / ORALAB1983-11-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018823-001FUROSEMIDE20MGTABLET / ORALAB1983-11-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018823-002FUROSEMIDE40MGTABLET / ORALAB1983-11-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018823-001FUROSEMIDE20MGTABLET / ORALAB1983-11-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018823-002FUROSEMIDE40MGTABLET / ORALAB1983-11-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018823-001FUROSEMIDE20MGTABLET / ORALAB1983-11-10782e0a99824c…
2021-12-28 21:50 UTC2021-12N018823-002FUROSEMIDE40MGTABLET / ORALAB1983-11-10782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N018823-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018823-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018823-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018823-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018823-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018823-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018823-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018823-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018823-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018823-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018823-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018823-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018823-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018823-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018823-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018823-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018823-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018823-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018823-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018823-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018823-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018823-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018823-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018823-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018823-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018823-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018823-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018823-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018823-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018823-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018823-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018823-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018823-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018823-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018823-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018823-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018823-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018823-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018823-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N018823-002AB1782e0a99824c…

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
71610-308-30Furosemide30 in 1 BOTTLETABLET301
71610-308-45Furosemide45 in 1 BOTTLETABLET451
71610-308-53Furosemide60 in 1 BOTTLETABLET601
71610-308-60Furosemide90 in 1 BOTTLETABLET901
71610-308-80Furosemide180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-308-30EA - Each71610-308906b4b45-5f32-4b47-9c74-6c57f2e92ef512019-09-05
71610-308-45EA - Each71610-3085e15d534-df5e-4d7f-adbb-14aea35477c512019-10-07
71610-308-53EA - Each71610-308d026aac3-1b42-4404-b4ae-d66c3a13938612019-09-05
71610-308-60EA - Each71610-308b02bb1ac-cc39-4233-8a77-dc6db5fad68a12019-09-05
71610-308-80EA - Each71610-30828246d4c-092d-4036-bcf1-622a1293d30012019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-308FUROSEMIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 5 package rows20190817_a0dd45a3-4ae8-4301-8d6c-a20eac80cb2c.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FurosemideFUROSEMIDENorthwind Health Company, LLCf3173c0d-2b62-7c7b-e053-2995a90ada052026-01-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 018823
application number: NDA018823
FurosemideFUROSEMIDEHikma Pharmaceuticals USA Inc.9e493331-dddd-496e-abf8-61747fb67aba2025-11-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 018823
application number: NDA018823
FurosemideFUROSEMIDEA-S Medication Solutionsa2e46e16-4adf-4599-b69d-a6f6f891ba752023-10-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 018823
application number: NDA018823
FurosemideFUROSEMIDEAphena Pharma Solutions - Tennessee, LLC6fbf7f3d-7566-44d5-9507-c4460238fc912018-02-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 018823
application number: NDA018823

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310429furosemide 20 MG Oral TabletPSNa0dd45a3-4ae8-4301-8d6c-a20eac80cb2c1
313988furosemide 40 MG Oral TabletPSNa0dd45a3-4ae8-4301-8d6c-a20eac80cb2c1
197732furosemide 80 MG Oral TabletPSNa0dd45a3-4ae8-4301-8d6c-a20eac80cb2c1
310429furosemide 20 MG Oral TabletSCDa0dd45a3-4ae8-4301-8d6c-a20eac80cb2c1
313988furosemide 40 MG Oral TabletSCDa0dd45a3-4ae8-4301-8d6c-a20eac80cb2c1
197732furosemide 80 MG Oral TabletSCDa0dd45a3-4ae8-4301-8d6c-a20eac80cb2c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-308-307161003083030 TABLET in 1 BOTTLE (71610-308-30) 30 tablet2019-07-160000-00-00NoNoCurrent