Bumex

Product NDC
30698-632
Requested package NDC
30698-632-01
11-digit product format
306980632
Labeler code
30698
Product ID
30698-632_3e4799b2-7621-c0b4-e063-6394a90a47b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
Validus Pharmaceuticals LLC
Application
NDA018225
Marketing category
NDA
Marketing start
1983-02-28
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

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 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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N018225-001BUMEXBUMETANIDE1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-28
N018225-002BUMEXBUMETANIDE0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD1983-02-28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
Bumex
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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197417Internal RxNorm lookup
197418Internal RxNorm lookup
197419Internal RxNorm lookup
205488Internal RxNorm lookup
205489Internal RxNorm lookup
205490Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
32dfbea3-eb2b-4070-8605-57ce3e6d5a2fAvailable 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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2025-09-08Bumex
2025-01-30Bumex
2023-12-14Bumex
2023-01-30Bumex

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30698-632-01Bumex100 in 1 BOTTLETABLET1005
30698-632-05Bumex500 in 1 BOTTLETABLET5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
30698-632-01EA - Each30698-6329acce2c7-931c-44ff-a19c-c6f3de3a1af312018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30698-632BUMEX (BUMETANIDE) TABLET [VALIDUS PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 2 package rows20231215_32dfbea3-eb2b-4070-8605-57ce3e6d5a2f.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
ndc (package): 30698-632-01
ndc (product): 30698-632
ndc11 (package): 30698063201
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 TabletPSN32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
197418bumetanide 1 MG Oral TabletPSN32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
197419bumetanide 2 MG Oral TabletPSN32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
205488Bumex 0.5 MG Oral TabletPSN32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
205489Bumex 1 MG Oral TabletPSN32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
205490Bumex 2 MG Oral TabletPSN32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
205488bumetanide 0.5 MG Oral Tablet [Bumex]SBD32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
205489bumetanide 1 MG Oral Tablet [Bumex]SBD32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
205490bumetanide 2 MG Oral Tablet [Bumex]SBD32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
197417bumetanide 0.5 MG Oral TabletSCD32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
197418bumetanide 1 MG Oral TabletSCD32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
197419bumetanide 2 MG Oral TabletSCD32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
205488Bumex 0.5 MG Oral TabletSY32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
205489Bumex 1 MG Oral TabletSY32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
205490Bumex 2 MG Oral TabletSY32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30698-632-0130698063201100 TABLET in 1 BOTTLE (30698-632-01) 100 tablet1983-02-280000-00-00NoNoCurrent