Bumetanide

Product NDC
63629-4968
11-digit product format
636294968
Labeler code
63629
Product ID
63629-4968_e3247459-31c2-48a5-959e-d3ec3d92be66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074700
Marketing category
ANDA
Marketing start
1996-11-21
Substance
BUMETANIDE
Active strength
1 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 · 5 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage63629-4968-4
excluded packagepackage63629-4968-2
excluded packagepackage63629-4968-1
excluded packagepackage63629-4968-3

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
A074700-001BUMETANIDEBUMETANIDE0.5MGTABLET / ORALAB1996-11-21
A074700-002BUMETANIDEBUMETANIDE1MGTABLET / ORALAB1996-11-21
A074700-003BUMETANIDEBUMETANIDE2MGTABLET / ORALABRS1996-11-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074700-001AB
A074700-002AB
A074700-003AB

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 UTC2026-02A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-218072bd15b7f6…

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 UTC2026-02A074700-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074700-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074700-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074700-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074700-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074700-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074700-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074700-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074700-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074700-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074700-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074700-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074700-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074700-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074700-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074700-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074700-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074700-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074700-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074700-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074700-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074700-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074700-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074700-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074700-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074700-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074700-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074700-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074700-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074700-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074700-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074700-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074700-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074700-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074700-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074700-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074700-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074700-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074700-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074700-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUMETANIDE1 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0fb6d547-9966-4352-8974-d02ea58e6445Available 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
1d3f2f0a-cce7-32fe-77bf-6ee61839e736Product name220171211

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4968-1Bumetanide30 in 1 BOTTLETABLET301014
63629-4968-2Bumetanide90 in 1 BOTTLETABLET901014
63629-4968-3Bumetanide28 in 1 BOTTLETABLET281014
63629-4968-4Bumetanide18 in 1 BOTTLETABLET181014
63629-4968-5Bumetanide60 in 1 BOTTLETABLET601014
63629-4968-6Bumetanide100 in 1 BOTTLETABLET1001014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUMETANIDEACTIVE INGREDIENT0Y2S3XUQ5HBUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
BUMETANIDEACTIVE MOIETY0Y2S3XUQ5HBUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933BUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1UBUMETANIDE TABLET [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4968BUMETANIDE TABLET [BRYANT RANCH PREPACK]1014Current NDC, Legacy NDC, 6 package rows20240726_0fb6d547-9966-4352-8974-d02ea58e6445.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BumetanideBUMETANIDESandoz Inc8914d8bf-61b7-4cd2-a8ef-7e1c5df378282026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEBryant Ranch Prepack12b9489a-b16b-4504-a660-e66fd52610692025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEBryant Ranch Prepackb2dcdf9b-70b9-493f-99b4-fc7dcc31939a2025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEBryant Ranch Prepack6b5450f2-ae91-48b6-ad83-261bdfcf47ac2025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEREMEDYREPACK INC.0fb78afc-d8bc-4ae8-8c0a-6d9c6f7a22c52025-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEBryant Ranch Prepacka7068f36-a863-4af0-9c82-e5394a6e7a542025-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEBryant Ranch Prepack056be255-5880-48e9-b160-bd5b3d82c24a2025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEBryant Ranch Prepack80fe034e-01b7-438e-8378-44fafb7a1d942025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEBryant Ranch Prepack0fb6d547-9966-4352-8974-d02ea58e64452024-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
ndc (product): 63629-4968
BumetanideBUMETANIDEProficient Rx LP6e3d3ea1-830f-4fc6-9c56-b2ec71875dc62024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEBryant Ranch Prepackf6f12a41-ae6d-4ce6-9bb1-e32679af665f2024-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDESandoz Inc05cb961d-ac33-4bcf-b04e-411e496c43c12023-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEA-S Medication Solutions7f9dccf8-37ff-454b-9d55-7f1d631c84832023-01-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEA-S Medication Solutionsf6ff0d37-c67d-4b9f-8b62-5deda9783c282023-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEA-S Medication Solutions8bed63fb-91ec-4132-ac0a-16c4c6f58d952023-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700
BumetanideBUMETANIDEAphena Pharma Solutions - Tennessee, LLC7e47e7b1-d28a-4e12-882f-cf193b7f26972019-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074700
application number: ANDA074700

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197418bumetanide 1 MG Oral TabletPSN0fb6d547-9966-4352-8974-d02ea58e64451014
197418bumetanide 1 MG Oral TabletSCD0fb6d547-9966-4352-8974-d02ea58e64451014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-4968-16362949680130 TABLET in 1 BOTTLE (63629-4968-1) 30 tablet2013-04-020000-00-00NoNoCurrent
63629-4968-26362949680290 TABLET in 1 BOTTLE (63629-4968-2) 90 tablet2016-04-260000-00-00NoNoCurrent
63629-4968-36362949680328 TABLET in 1 BOTTLE (63629-4968-3) 28 tablet2022-04-290000-00-00NoNoCurrent
63629-4968-46362949680418 TABLET in 1 BOTTLE (63629-4968-4) 18 tablet2022-04-290000-00-00NoNoCurrent
63629-4968-56362949680560 TABLET in 1 BOTTLE (63629-4968-5) 60 tablet2022-04-290000-00-00NoNoCurrent
63629-4968-663629496806100 TABLET in 1 BOTTLE (63629-4968-6) 100 tablet2022-04-29NoNoCurrent