bumetanide

Product NDC
23155-900
11-digit product format
231550900
Labeler code
23155
Product ID
23155-900_ee0c44ac-10ca-4d9b-98f0-1342fc97dd39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA074225
Marketing category
ANDA
Marketing start
2025-07-15
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
A074225-001BUMETANIDEBUMETANIDE0.5MGTABLET / ORALAB1995-04-24
A074225-002BUMETANIDEBUMETANIDE1MGTABLET / ORALAB1995-04-24
A074225-003BUMETANIDEBUMETANIDE2MGTABLET / ORALAB1995-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074225-001AB
A074225-002AB
A074225-003AB

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 UTC2026-02A074225-001BUMETANIDE0.5MGTABLET / ORALAB1995-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074225-002BUMETANIDE1MGTABLET / ORALAB1995-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074225-003BUMETANIDE2MGTABLET / ORALAB1995-04-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074225-001BUMETANIDE0.5MGTABLET / ORALAB1995-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074225-002BUMETANIDE1MGTABLET / ORALAB1995-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074225-003BUMETANIDE2MGTABLET / ORALAB1995-04-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A074225-001BUMETANIDE0.5MGTABLET / ORALAB1995-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074225-002BUMETANIDE1MGTABLET / ORALAB1995-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074225-003BUMETANIDE2MGTABLET / ORALAB1995-04-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074225-001BUMETANIDE0.5MGTABLET / ORALAB1995-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074225-002BUMETANIDE1MGTABLET / ORALAB1995-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074225-003BUMETANIDE2MGTABLET / ORALAB1995-04-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074225-001BUMETANIDE0.5MGTABLET / ORALAB1995-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074225-002BUMETANIDE1MGTABLET / ORALAB1995-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074225-003BUMETANIDE2MGTABLET / ORALAB1995-04-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074225-001BUMETANIDE0.5MGTABLET / ORALAB1995-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074225-002BUMETANIDE1MGTABLET / ORALAB1995-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074225-003BUMETANIDE2MGTABLET / ORALAB1995-04-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074225-001BUMETANIDE0.5MGTABLET / ORALAB1995-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074225-002BUMETANIDE1MGTABLET / ORALAB1995-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074225-003BUMETANIDE2MGTABLET / ORALAB1995-04-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074225-001BUMETANIDE0.5MGTABLET / ORALAB1995-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074225-002BUMETANIDE1MGTABLET / ORALAB1995-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074225-003BUMETANIDE2MGTABLET / ORALAB1995-04-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074225-001BUMETANIDE0.5MGTABLET / ORALAB1995-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074225-002BUMETANIDE1MGTABLET / ORALAB1995-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074225-003BUMETANIDE2MGTABLET / ORALAB1995-04-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074225-001BUMETANIDE0.5MGTABLET / ORALAB1995-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A074225-002BUMETANIDE1MGTABLET / ORALAB1995-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A074225-003BUMETANIDE2MGTABLET / ORALAB1995-04-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074225-001BUMETANIDE0.5MGTABLET / ORALAB1995-04-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074225-002BUMETANIDE1MGTABLET / ORALAB1995-04-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074225-003BUMETANIDE2MGTABLET / ORALAB1995-04-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074225-001BUMETANIDE0.5MGTABLET / ORALAB1995-04-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074225-002BUMETANIDE1MGTABLET / ORALAB1995-04-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074225-003BUMETANIDE2MGTABLET / ORALAB1995-04-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074225-001BUMETANIDE0.5MGTABLET / ORALAB1995-04-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074225-002BUMETANIDE1MGTABLET / ORALAB1995-04-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074225-003BUMETANIDE2MGTABLET / ORALAB1995-04-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074225-001BUMETANIDE0.5MGTABLET / ORALAB1995-04-248072bd15b7f6…

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 UTC2026-02A074225-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074225-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074225-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074225-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074225-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074225-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074225-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074225-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074225-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074225-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074225-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074225-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074225-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074225-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074225-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074225-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074225-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074225-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074225-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074225-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074225-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074225-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074225-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074225-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074225-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074225-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074225-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074225-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074225-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074225-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074225-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074225-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074225-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074225-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074225-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074225-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074225-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074225-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074225-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074225-001AB18072bd15b7f6…

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
d4688d53-9baf-4cf0-b37f-47779bce7815Available 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
23155-900-01bumetanide100 in 1 BOTTLETABLET1002
23155-900-05bumetanide500 in 1 BOTTLETABLET5002
23155-900-10bumetanide1000 in 1 BOTTLETABLET10002

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bumetanideBUMETANIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.d4688d53-9baf-4cf0-b37f-47779bce78152025-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074225
application number: ANDA074225
ndc (product): 23155-900
bumetanideBUMETANIDENorthStar Rx, LLC6b92460e-48ba-44bb-9b61-5e65e5fd82cd2025-03-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074225
application number: ANDA074225

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197417bumetanide 0.5 MG Oral TabletPSNd4688d53-9baf-4cf0-b37f-47779bce78152
197418bumetanide 1 MG Oral TabletPSNd4688d53-9baf-4cf0-b37f-47779bce78152
197419bumetanide 2 MG Oral TabletPSNd4688d53-9baf-4cf0-b37f-47779bce78152
197417bumetanide 0.5 MG Oral TabletSCDd4688d53-9baf-4cf0-b37f-47779bce78152
197418bumetanide 1 MG Oral TabletSCDd4688d53-9baf-4cf0-b37f-47779bce78152
197419bumetanide 2 MG Oral TabletSCDd4688d53-9baf-4cf0-b37f-47779bce78152

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23155-900-0123155090001100 TABLET in 1 BOTTLE (23155-900-01) 100 tablet2025-07-15NoNoCurrent
23155-900-0523155090005500 TABLET in 1 BOTTLE (23155-900-05) 500 tablet2025-07-15NoNoCurrent
23155-900-10231550900101000 TABLET in 1 BOTTLE (23155-900-10) 1000 tablet2025-07-15NoNoCurrent