Bumetanide

Product NDC
42799-119
11-digit product format
427990119
Labeler code
42799
Product ID
42799-119_462dc93e-f284-3a48-e063-6394a90a7ce1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
Edenbridge Pharmaceuticals LLC.
Application
NDA018225
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-10-15
Substance
BUMETANIDE
Active strength
.5 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 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N018225-001BUMEXBUMETANIDE1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-28
N018225-002BUMEXBUMETANIDE0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-28
N018225-003BUMEXBUMETANIDE2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1985-06-14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2026-02-19 14:30 UTC2026-02N018225-001BUMEX1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-28011fe1cb6892…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
BUMETANIDE.5 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197417Internal RxNorm lookup
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
32c4372e-54ea-4fc8-b9f8-827fa4c8edd3Available 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
42799-119-01Bumetanide100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42799-119-01EA - Each42799-11912ef3739-5969-4d05-9377-8364f7c19cfb12015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BumetanideACTIVE INGREDIENT0Y2S3XUQ5HBUMETANIDE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]1
BumetanideACTIVE MOIETY0Y2S3XUQ5HBUMETANIDE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUMETANIDE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUMETANIDE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBUMETANIDE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBUMETANIDE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BUMETANIDE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUMETANIDE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUMETANIDE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBUMETANIDE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42799-119BUMETANIDE TABLET [EDENBRIDGE PHARMACEUTICALS LLC.]4Current NDC, Legacy NDC, 1 package rows20190402_32c4372e-54ea-4fc8-b9f8-827fa4c8edd3.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
ndc (product): 42799-119
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197417bumetanide 0.5 MG Oral TabletPSN32c4372e-54ea-4fc8-b9f8-827fa4c8edd36
197418bumetanide 1 MG Oral TabletPSN32c4372e-54ea-4fc8-b9f8-827fa4c8edd36
197419bumetanide 2 MG Oral TabletPSN32c4372e-54ea-4fc8-b9f8-827fa4c8edd36
197417bumetanide 0.5 MG Oral TabletSCD32c4372e-54ea-4fc8-b9f8-827fa4c8edd36
197418bumetanide 1 MG Oral TabletSCD32c4372e-54ea-4fc8-b9f8-827fa4c8edd36
197419bumetanide 2 MG Oral TabletSCD32c4372e-54ea-4fc8-b9f8-827fa4c8edd36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42799-119-0142799011901100 TABLET in 1 BOTTLE (42799-119-01) 100 tablet2015-10-150000-00-00NoNoCurrent