bumetanide

Product NDC
16714-833
11-digit product format
167140833
Labeler code
16714
Product ID
16714-833_3f2c7e4c-9e79-4335-a7da-5beb2dde5543
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
Northstar Rx LLC
Application
ANDA202900
Marketing category
ANDA
Marketing start
2018-06-25
Marketing end
0000-00-00
Substance
BUMETANIDE
Active strength
2 mg/1
Pharmacologic classes
Loop Diuretic [EPC],Increased Diuresis at Loop of Henle [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct16714-833DDiscontinued by firm2026-08-07
excluded packagepackage16714-83316714-833-01DDiscontinued by firm2026-08-07
excluded packagepackage16714-83316714-833-02DDiscontinued 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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage16714-833-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage16714-833-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage16714-833-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage16714-833-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage16714-833-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage16714-833-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage16714-833-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage16714-833-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage16714-833-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage16714-833-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage16714-833-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage16714-833-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage16714-833-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage16714-833-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage16714-833-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage16714-833-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage16714-833-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage16714-833-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16714-833-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16714-833-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16714-833-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16714-833-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16714-833-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16714-833-02557ba5c1ecfa…9c80585c8c6e…

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
A202900-001BUMETANIDEBUMETANIDE0.5MGTABLET / ORALAB2018-04-30
A202900-002BUMETANIDEBUMETANIDE1MGTABLET / ORALAB2018-04-30
A202900-003BUMETANIDEBUMETANIDE2MGTABLET / ORALAB2018-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202900-001AB
A202900-002AB
A202900-003AB

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 UTC2026-02A202900-001BUMETANIDE0.5MGTABLET / ORALAB2018-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202900-002BUMETANIDE1MGTABLET / ORALAB2018-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202900-003BUMETANIDE2MGTABLET / ORALAB2018-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202900-001BUMETANIDE0.5MGTABLET / ORALAB2018-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202900-002BUMETANIDE1MGTABLET / ORALAB2018-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202900-003BUMETANIDE2MGTABLET / ORALAB2018-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A202900-001BUMETANIDE0.5MGTABLET / ORALAB2018-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202900-002BUMETANIDE1MGTABLET / ORALAB2018-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202900-003BUMETANIDE2MGTABLET / ORALAB2018-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202900-001BUMETANIDE0.5MGTABLET / ORALAB2018-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202900-002BUMETANIDE1MGTABLET / ORALAB2018-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202900-003BUMETANIDE2MGTABLET / ORALAB2018-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202900-001BUMETANIDE0.5MGTABLET / ORALAB2018-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202900-002BUMETANIDE1MGTABLET / ORALAB2018-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202900-003BUMETANIDE2MGTABLET / ORALAB2018-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202900-001BUMETANIDE0.5MGTABLET / ORALAB2018-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202900-002BUMETANIDE1MGTABLET / ORALAB2018-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202900-003BUMETANIDE2MGTABLET / ORALAB2018-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202900-001BUMETANIDE0.5MGTABLET / ORALAB2018-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202900-002BUMETANIDE1MGTABLET / ORALAB2018-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202900-003BUMETANIDE2MGTABLET / ORALAB2018-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202900-001BUMETANIDE0.5MGTABLET / ORALAB2018-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202900-002BUMETANIDE1MGTABLET / ORALAB2018-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202900-003BUMETANIDE2MGTABLET / ORALAB2018-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202900-001BUMETANIDE0.5MGTABLET / ORALAB2018-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202900-002BUMETANIDE1MGTABLET / ORALAB2018-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202900-003BUMETANIDE2MGTABLET / ORALAB2018-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202900-001BUMETANIDE0.5MGTABLET / ORALAB2018-04-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A202900-002BUMETANIDE1MGTABLET / ORALAB2018-04-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A202900-003BUMETANIDE2MGTABLET / ORALAB2018-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202900-001BUMETANIDE0.5MGTABLET / ORALAB2018-04-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202900-002BUMETANIDE1MGTABLET / ORALAB2018-04-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202900-003BUMETANIDE2MGTABLET / ORALAB2018-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202900-001BUMETANIDE0.5MGTABLET / ORALAB2018-04-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202900-002BUMETANIDE1MGTABLET / ORALAB2018-04-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202900-003BUMETANIDE2MGTABLET / ORALAB2018-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202900-001BUMETANIDE0.5MGTABLET / ORALAB2018-04-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202900-002BUMETANIDE1MGTABLET / ORALAB2018-04-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202900-003BUMETANIDE2MGTABLET / ORALAB2018-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202900-001BUMETANIDE0.5MGTABLET / ORALAB2018-04-308072bd15b7f6…

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 UTC2026-02A202900-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202900-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202900-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202900-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202900-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202900-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202900-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202900-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202900-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202900-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202900-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202900-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202900-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202900-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202900-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202900-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202900-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202900-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202900-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202900-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202900-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202900-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202900-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202900-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202900-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202900-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202900-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202900-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202900-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202900-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202900-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202900-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202900-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202900-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202900-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202900-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202900-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202900-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202900-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202900-001AB18072bd15b7f6…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-833-01EA - Each16714-83377770b36-aa09-420d-899a-eb138ba9f70812018-12-13
16714-833-02EA - Each16714-833aabc6c21-b976-450e-8751-dda78aff2e1312018-12-13

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bumetanideBUMETANIDEA-S Medication Solutions8b5a38cc-1e76-4821-b286-31bad3bd69132026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202900
application number: ANDA202900
bumetanideBUMETANIDEBryant Ranch Prepacka60bfe5f-d0d6-4d15-a3de-32dc68e41af32024-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202900
application number: ANDA202900
bumetanideBUMETANIDEZydus Pharmaceuticals (USA) Inc.525138cd-832a-41d0-84b0-83921b12bd2a2023-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202900
application number: ANDA202900
bumetanideBUMETANIDEZydus Lifesciences Limited82eb62ca-c32b-4ff8-9f71-43219b2404802023-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202900
application number: ANDA202900
bumetanideBUMETANIDEA-S Medication Solutionscf29e436-b630-4b03-bb9b-9267ae77dc002023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202900
application number: ANDA202900

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197419bumetanide 2 MG Oral TabletPSN9a1adf69-35c8-4987-b12f-3e26239158321
197419bumetanide 2 MG Oral TabletSCD9a1adf69-35c8-4987-b12f-3e26239158321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-833-0116714083301100 TABLET in 1 BOTTLE (16714-833-01) 100 tablet2018-06-250000-00-00NoNoCurrent
16714-833-0216714083302500 TABLET in 1 BOTTLE (16714-833-02) 500 tablet2018-06-250000-00-00NoNoCurrent