Bumetanide

Product NDC
60687-535
11-digit product format
606870535
Labeler code
60687
Product ID
60687-535_21374d66-9881-6023-e063-6394a90a39d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
NDA018225
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-07-13
Substance
BUMETANIDE
Active strength
2 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 packagepackage60687-53560687-535-01DDiscontinued by firm2026-08-07

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 · 11 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…

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
N018225-001BUMEXBUMETANIDE1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-28
N018225-002BUMEXBUMETANIDE0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-28
N018225-003BUMEXBUMETANIDE2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1985-06-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018225-001AB
N018225-002AB
N018225-003AB

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 UTC2026-02N018225-001BUMEX1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018225-002BUMEX0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018225-003BUMEX2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1985-06-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018225-001BUMEX1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018225-002BUMEX0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018225-003BUMEX2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1985-06-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N018225-001BUMEX1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018225-002BUMEX0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018225-003BUMEX2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1985-06-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018225-001BUMEX1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018225-002BUMEX0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018225-003BUMEX2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1985-06-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018225-001BUMEX1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018225-002BUMEX0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018225-003BUMEX2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1985-06-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018225-001BUMEX1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018225-002BUMEX0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018225-003BUMEX2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1985-06-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018225-001BUMEX1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018225-002BUMEX0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018225-003BUMEX2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1985-06-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018225-001BUMEX1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018225-002BUMEX0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018225-003BUMEX2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1985-06-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018225-001BUMEX1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018225-002BUMEX0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018225-003BUMEX2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1985-06-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018225-001BUMEX1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N018225-002BUMEX0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N018225-003BUMEX2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1985-06-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018225-001BUMEX1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018225-002BUMEX0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018225-003BUMEX2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1985-06-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018225-001BUMEX1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018225-002BUMEX0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018225-003BUMEX2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1985-06-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018225-001BUMEX1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018225-002BUMEX0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018225-003BUMEX2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1985-06-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018225-001BUMEX1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-288072bd15b7f6…

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 UTC2026-02N018225-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018225-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018225-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018225-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018225-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018225-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018225-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018225-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018225-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018225-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018225-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018225-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018225-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018225-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018225-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018225-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018225-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018225-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018225-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018225-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018225-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018225-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018225-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018225-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018225-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018225-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018225-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018225-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018225-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018225-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018225-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018225-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018225-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018225-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018225-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018225-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018225-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018225-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018225-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018225-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUMETANIDE2 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197418Internal RxNorm lookup
197419Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5e9633e4-151b-4f40-885e-8f364f6f2d18Available 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
60687-535-01Bumetanide100 in 1 BOX, UNIT-DOSETABLET1007
60687-535-11Bumetanide1 in 1 BLISTER PACKTABLET17
60687-535-65Bumetanide50 in 1 CARTONTABLET507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-535-01EA - Each60687-535a939233c-6598-4799-9b4b-33d2f82fb54c12020-07-13
60687-535-11EA - Each60687-535673f6c65-2ad9-4a71-803c-64aa1ef7277412020-07-13
60687-535-65EA - Each60687-535e286d036-6f3d-4045-b0d2-6d24004bb67512024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-535BUMETANIDE TABLET [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 3 package rows20240904_5e9633e4-151b-4f40-885e-8f364f6f2d18.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
BumetanideBUMETANIDEEdenbridge Pharmaceuticals LLC.32c4372e-54ea-4fc8-b9f8-827fa4c8edd32025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018225
application number: NDA018225
BumexBUMETANIDEValidus Pharmaceuticals LLC32dfbea3-eb2b-4070-8605-57ce3e6d5a2f2025-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018225
application number: NDA018225
BumetanideBUMETANIDEAmerican Health Packaging5e9633e4-151b-4f40-885e-8f364f6f2d182024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018225
application number: NDA018225
ndc (product): 60687-535

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197418bumetanide 1 MG Oral TabletPSN5e9633e4-151b-4f40-885e-8f364f6f2d187
197419bumetanide 2 MG Oral TabletPSN5e9633e4-151b-4f40-885e-8f364f6f2d187
197418bumetanide 1 MG Oral TabletSCD5e9633e4-151b-4f40-885e-8f364f6f2d187
197419bumetanide 2 MG Oral TabletSCD5e9633e4-151b-4f40-885e-8f364f6f2d187

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-535-0160687053501100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-535-01) > 1 TABLET in 1 BLISTER PACK (60687-535-11) 100 blister pack2020-03-200000-00-00NoNoCurrent
60687-535-11606870535111 in 1 BLISTER PACKHistorical
60687-535-656068705356550 BLISTER PACK in 1 CARTON (60687-535-65) / 1 TABLET in 1 BLISTER PACK (60687-535-11) 50 blister pack2024-09-01NoNoCurrent