FDA.reportPublic FDA data

Bumetanide

Product NDC
70518-4387
Requested package NDC
70518-4387-0
11-digit product format
705184387
Labeler code
70518
Product ID
70518-4387_3955d55c-b866-e166-e063-6394a90af1f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA074700
Marketing category
ANDA
Marketing start
2025-07-06
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

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A074700-001BUMETANIDE0.5MGTABLET / ORALAB1996-11-21a50c72e98297…
2026-08-01 22:54:322026-06A074700-002BUMETANIDE1MGTABLET / ORALAB1996-11-21a50c72e98297…
2026-08-01 22:54:322026-06A074700-003BUMETANIDE2MGTABLET / ORALABRS1996-11-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A074700-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A074700-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A074700-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (package): 70518-4387-0
ndc (product): 70518-4387
ndc11 (package): 70518438700
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
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

Additional Listing Data#

Finished product
Yes
Brand name base
Bumetanide
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
0fb78afc-d8bc-4ae8-8c0a-6d9c6f7a22c5Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4387-0Bumetanide90 in 1 BOTTLE, PLASTICTABLET901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197419bumetanide 2 MG Oral TabletPSN0fb78afc-d8bc-4ae8-8c0a-6d9c6f7a22c51
197419bumetanide 2 MG Oral TabletSCD0fb78afc-d8bc-4ae8-8c0a-6d9c6f7a22c51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4387-07051843870090 TABLET in 1 BOTTLE, PLASTIC (70518-4387-0) 90 tablet2025-07-06NoNoCurrent