Furosemide

Product NDC
69315-117
11-digit product format
693150117
Labeler code
69315
Product ID
69315-117_445bfa17-a52c-4492-9dbc-94218b30c1db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Furosemide
Dosage form
TABLET
Route
ORAL
Labeler
Leading Pharma, LLC
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 44.

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-09c2088c7a36db…
2026-10-15 13:18:302026-09A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-09c2088c7a36db…
2026-10-15 13:18:302026-09A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-09c2088c7a36db…
2026-09-14 22:38:342026-08A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-0984e616aacf4f…
2026-09-14 22:38:342026-08A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-0984e616aacf4f…
2026-09-14 22:38:342026-08A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-0984e616aacf4f…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A077293-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A077293-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A077293-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A077293-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077293-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077293-003AB184e616aacf4f…
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…

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
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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197732Internal RxNorm lookup
310429Internal RxNorm lookup
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
b5c6fcf4-fd37-4fee-8dac-1a3273d95ffeAvailable 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
69315-117-01Furosemide100 in 1 BOTTLETABLET10010
69315-117-10Furosemide1000 in 1 BOTTLETABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-117-01EA - Each69315-117293933ea-117a-4637-a20d-037f11ca459b12016-05-16
69315-117-10EA - Each69315-11777d612ee-bf09-4a7b-ab23-994bafbb06c812016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-117FUROSEMIDE (FUROSEMIDE) TABLET [LEADING PHARMA, LLC]10Current NDC, Legacy NDC, 2 package rows20221117_b5c6fcf4-fd37-4fee-8dac-1a3273d95ffe.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 2 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FurosemideFUROSEMIDECalvin Scott & Co., Inc.b2cc89e5-6619-4113-ad31-48076652c8562024-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FUROSEMIDEFUROSEMIDEDIRECT RX9ec7808e-9201-4b8c-9790-d329320dc6c42024-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDEA-S Medication Solutions60cf5e60-9a7a-42c2-95b5-016f7a68ffc42023-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDEA-S Medication Solutions25171259-dcf1-4984-9581-cd69dee8dffb2023-04-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDECalvin Scott & Co., Inc.43be0231-0d88-4a21-b2ab-793155cbddb22023-03-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDEA-S Medication Solutions52f0c9d5-396f-4033-abe8-145eec3e69832023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDEProficient Rx LP595ddaf2-c2cb-44a4-a46c-53bcfe6bd7522022-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDELeading Pharma, LLCb5c6fcf4-fd37-4fee-8dac-1a3273d95ffe2022-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
ndc (product): 69315-117
FurosemideFUROSEMIDEProficient Rx LPce84359c-2f76-421a-9b2b-79b1c2be2f202021-01-01Warnings, 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 TabletPSN916de29e-228c-4dfc-bcee-ad9a641316bd27
313988furosemide 40 MG Oral TabletSCD916de29e-228c-4dfc-bcee-ad9a641316bd27
313988furosemide 40 MG Oral TabletPSN83662449-f2b1-48a3-9021-13037e64e6ea19
197732furosemide 80 MG Oral TabletPSN83662449-f2b1-48a3-9021-13037e64e6ea19
313988furosemide 40 MG Oral TabletSCD83662449-f2b1-48a3-9021-13037e64e6ea19
197732furosemide 80 MG Oral TabletSCD83662449-f2b1-48a3-9021-13037e64e6ea19
313988furosemide 40 MG Oral TabletPSNe20257f6-7cfe-43fa-a672-cc1cb312b83a16
313988furosemide 40 MG Oral TabletSCDe20257f6-7cfe-43fa-a672-cc1cb312b83a16
313988furosemide 40 MG Oral TabletPSNa23fc1e0-2d16-43a8-a34e-f6505dcd631611
313988furosemide 40 MG Oral TabletSCDa23fc1e0-2d16-43a8-a34e-f6505dcd631611
310429furosemide 20 MG Oral TabletPSNb5c6fcf4-fd37-4fee-8dac-1a3273d95ffe10
313988furosemide 40 MG Oral TabletPSNb5c6fcf4-fd37-4fee-8dac-1a3273d95ffe10
197732furosemide 80 MG Oral TabletPSNb5c6fcf4-fd37-4fee-8dac-1a3273d95ffe10
310429furosemide 20 MG Oral TabletSCDb5c6fcf4-fd37-4fee-8dac-1a3273d95ffe10
313988furosemide 40 MG Oral TabletSCDb5c6fcf4-fd37-4fee-8dac-1a3273d95ffe10
197732furosemide 80 MG Oral TabletSCDb5c6fcf4-fd37-4fee-8dac-1a3273d95ffe10
313988furosemide 40 MG Oral TabletPSN809d9734-12dd-3b1f-e053-2a91aa0aadee7
313988furosemide 40 MG Oral TabletPSN600ca175-be2b-4c43-b119-133ae21a56017
313988furosemide 40 MG Oral TabletSCD809d9734-12dd-3b1f-e053-2a91aa0aadee7
313988furosemide 40 MG Oral TabletSCD600ca175-be2b-4c43-b119-133ae21a56017
313988furosemide 40 MG Oral TabletPSN341e29d9-a6f1-4c77-ae44-9b2c423ea6b46
313988furosemide 40 MG Oral TabletSCD341e29d9-a6f1-4c77-ae44-9b2c423ea6b46
313988furosemide 40 MG Oral TabletPSN25171259-dcf1-4984-9581-cd69dee8dffb5
313988furosemide 40 MG Oral TabletPSN865cd360-30af-43b9-a0b9-f90bbc94624f5
313988furosemide 40 MG Oral TabletSCD865cd360-30af-43b9-a0b9-f90bbc94624f5
313988furosemide 40 MG Oral TabletSCD25171259-dcf1-4984-9581-cd69dee8dffb5
310429furosemide 20 MG Oral TabletPSNe44cc8ac-1e04-4910-bde1-1f4a45a6937f3
310429furosemide 20 MG Oral TabletPSN1d99e151-75ba-6a75-e063-6294a90a43603
310429furosemide 20 MG Oral TabletPSNd19c0b31-bb9f-4457-9fdd-2dcd27f8b9bb3
313988furosemide 40 MG Oral TabletPSNe44cc8ac-1e04-4910-bde1-1f4a45a6937f3
313988furosemide 40 MG Oral TabletPSNd19c0b31-bb9f-4457-9fdd-2dcd27f8b9bb3
313988furosemide 40 MG Oral TabletPSN1d99e151-75ba-6a75-e063-6294a90a43603
310429furosemide 20 MG Oral TabletSCDd19c0b31-bb9f-4457-9fdd-2dcd27f8b9bb3
310429furosemide 20 MG Oral TabletSCDe44cc8ac-1e04-4910-bde1-1f4a45a6937f3
310429furosemide 20 MG Oral TabletSCD1d99e151-75ba-6a75-e063-6294a90a43603
313988furosemide 40 MG Oral TabletSCDd19c0b31-bb9f-4457-9fdd-2dcd27f8b9bb3
313988furosemide 40 MG Oral TabletSCDe44cc8ac-1e04-4910-bde1-1f4a45a6937f3
313988furosemide 40 MG Oral TabletSCD1d99e151-75ba-6a75-e063-6294a90a43603
313988furosemide 40 MG Oral TabletPSN3f6529fb-1173-ada3-e063-6294a90a76cb2
313988furosemide 40 MG Oral TabletPSNe9be5c3b-4b18-7ad2-e053-2995a90a4a8b2
313988furosemide 40 MG Oral TabletSCD3f6529fb-1173-ada3-e063-6294a90a76cb2
313988furosemide 40 MG Oral TabletSCDe9be5c3b-4b18-7ad2-e053-2995a90a4a8b2
313988furosemide 40 MG Oral TabletPSNb2cc89e5-6619-4113-ad31-48076652c8561
313988furosemide 40 MG Oral TabletPSN743f4ac5-756d-42fd-82df-d359924f62c01
313988furosemide 40 MG Oral TabletPSN60cf5e60-9a7a-42c2-95b5-016f7a68ffc41
313988furosemide 40 MG Oral TabletSCDb2cc89e5-6619-4113-ad31-48076652c8561
313988furosemide 40 MG Oral TabletSCD743f4ac5-756d-42fd-82df-d359924f62c01
313988furosemide 40 MG Oral TabletSCD60cf5e60-9a7a-42c2-95b5-016f7a68ffc41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69315-117-0169315011701100 TABLET in 1 BOTTLE (69315-117-01) 100 tablet2016-05-150000-00-00NoNoCurrent
69315-117-10693150117101000 TABLET in 1 BOTTLE (69315-117-10) 1000 tablet2016-05-150000-00-00NoNoCurrent