Bumetanide

Product NDC
43353-288
Requested package NDC
43353-288-74
11-digit product format
433530288
Labeler code
43353
Product ID
43353-288_b1b7dc90-3e5c-48cf-8a65-446c52e79d53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA074700
Marketing category
ANDA
Marketing start
1996-11-21
Substance
BUMETANIDE
Active strength
1 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

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 packagepackage43353-28843353-288-74DDiscontinued by firm2026-08-17

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 · 12 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…

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
A074700-001BUMETANIDEBUMETANIDE0.5MGTABLET / ORALAB1996-11-21
A074700-002BUMETANIDEBUMETANIDE1MGTABLET / ORALAB1996-11-21
A074700-003BUMETANIDEBUMETANIDE2MGTABLET / ORALABRS1996-11-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A074700-001AB
A074700-002AB
A074700-003AB

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 06:07:402026-07A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-21caaa826d4ba7…
2026-08-18 06:07:402026-07A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-21caaa826d4ba7…
2026-08-18 06:07:402026-07A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-211e350fbaab3a…

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 06:07:402026-07A074700-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074700-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074700-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074700-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074700-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074700-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074700-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074700-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074700-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074700-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074700-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074700-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074700-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074700-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074700-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074700-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074700-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074700-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074700-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074700-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074700-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074700-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074700-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074700-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074700-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074700-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074700-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074700-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074700-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074700-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074700-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074700-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074700-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074700-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074700-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074700-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074700-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074700-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074700-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074700-001AB11e350fbaab3a…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUMETANIDE1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0Y2S3XUQ5HInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197418Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7e47e7b1-d28a-4e12-882f-cf193b7f2697Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1d3f2f0a-cce7-32fe-77bf-6ee61839e736Product name920260113
601d9750-f415-d9d9-619c-0a87b4d3f237Product name320250331
1d3f2f0a-cce7-32fe-77bf-6ee61839e736Product name220171211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-288-09Bumetanide9000 in 1 BOTTLETABLET90002
43353-288-74Bumetanide9000 in 1 BOTTLETABLET90002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-288-09EA - Each43353-288d4d60065-ec00-4791-a2eb-11ef611ac95b12017-11-06
43353-288-74EA - Each43353-288e1cfc1a0-362a-4395-b5ec-0ebf59e06f3412019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-288BUMETANIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 2 package rows20191002_7e47e7b1-d28a-4e12-882f-cf193b7f2697.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BumetanideBUMETANIDESandoz Inc8914d8bf-61b7-4cd2-a8ef-7e1c5df378282026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEBryant Ranch Prepack12b9489a-b16b-4504-a660-e66fd52610692025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEBryant Ranch Prepackb2dcdf9b-70b9-493f-99b4-fc7dcc31939a2025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEBryant Ranch Prepack6b5450f2-ae91-48b6-ad83-261bdfcf47ac2025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEREMEDYREPACK INC.0fb78afc-d8bc-4ae8-8c0a-6d9c6f7a22c52025-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEBryant Ranch Prepacka7068f36-a863-4af0-9c82-e5394a6e7a542025-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEBryant Ranch Prepack056be255-5880-48e9-b160-bd5b3d82c24a2025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEBryant Ranch Prepack80fe034e-01b7-438e-8378-44fafb7a1d942025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEBryant Ranch Prepack0fb6d547-9966-4352-8974-d02ea58e64452024-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEProficient Rx LP6e3d3ea1-830f-4fc6-9c56-b2ec71875dc62024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEBryant Ranch Prepackf6f12a41-ae6d-4ce6-9bb1-e32679af665f2024-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDESandoz Inc05cb961d-ac33-4bcf-b04e-411e496c43c12023-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEA-S Medication Solutions7f9dccf8-37ff-454b-9d55-7f1d631c84832023-01-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEA-S Medication Solutionsf6ff0d37-c67d-4b9f-8b62-5deda9783c282023-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEA-S Medication Solutions8bed63fb-91ec-4132-ac0a-16c4c6f58d952023-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEAphena Pharma Solutions - Tennessee, LLC7e47e7b1-d28a-4e12-882f-cf193b7f26972019-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
ndc (package): 43353-288-74
ndc (product): 43353-288
ndc11 (package): 43353028874

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197418bumetanide 1 MG Oral TabletPSN7e47e7b1-d28a-4e12-882f-cf193b7f26972
197418bumetanide 1 MG Oral TabletSCD7e47e7b1-d28a-4e12-882f-cf193b7f26972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-288-74433530288749000 TABLET in 1 BOTTLE (43353-288-74) 9000 tablet2019-06-262021-12-24NoNoCurrent