Bumetanide

Product NDC: 43547-897
Requested package NDC: 43547-897-10
11-digit product format: 435470897
Labeler code: 43547
Product ID: 43547-897_4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bumetanide
Dosage form: TABLET
Route: ORAL
Labeler: Solco Healthcare LLC
Application: ANDA212931
Marketing category: ANDA
Marketing start: 2025-03-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212931-001	BUMETANIDE	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2024-09-18
A212931-002	BUMETANIDE	BUMETANIDE	1MG	TABLET / ORAL	AB	2024-09-18
A212931-003	BUMETANIDE	BUMETANIDE	2MG	TABLET / ORAL	AB	2024-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212931-001	AB
A212931-002	AB
A212931-003	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A212931-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2024-09-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212931-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2024-09-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212931-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2024-09-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212931-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2024-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212931-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2024-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212931-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2024-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212931-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2024-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212931-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2024-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212931-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2024-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212931-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2024-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212931-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2024-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212931-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2024-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212931-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2024-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212931-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2024-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212931-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2024-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212931-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2024-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212931-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2024-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212931-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2024-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212931-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2024-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212931-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2024-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212931-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2024-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212931-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2024-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212931-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2024-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212931-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2024-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212931-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2024-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212931-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2024-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212931-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2024-09-18	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212931-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2024-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212931-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2024-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212931-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2024-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212931-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2024-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212931-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2024-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212931-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2024-09-18	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212931-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2024-09-18	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212931-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2024-09-18	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212931-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2024-09-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212931-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212931-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212931-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212931-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212931-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212931-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212931-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212931-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212931-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212931-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212931-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212931-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212931-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212931-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212931-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212931-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212931-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212931-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212931-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212931-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212931-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212931-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212931-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212931-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212931-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212931-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212931-003	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212931-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212931-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212931-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212931-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212931-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212931-003	AB	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212931-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212931-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212931-003	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUMETANIDE	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0Y2S3XUQ5H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197417	Internal RxNorm lookup
197418	Internal RxNorm lookup
197419	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1d3f2f0a-cce7-32fe-77bf-6ee61839e736	Product name	9	20260113
601d9750-f415-d9d9-619c-0a87b4d3f237	Product name	3	20250331
1d3f2f0a-cce7-32fe-77bf-6ee61839e736	Product name	2	20171211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43547-897-10	Bumetanide	100 in 1 BOTTLE	TABLET	100		1
43547-897-50	Bumetanide	500 in 1 BOTTLE	TABLET	500		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43547-897-10	EA - Each	43547-897	07df16c6-8589-4b6b-9ca6-a36e4258c005	1	2025-03-04
43547-897-50	EA - Each	43547-897	66556c4d-3bc4-4ac4-9857-d2c41137e527	1	2025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43547-897	BUMETANIDE TABLET [SOLCO HEALTHCARE LLC]	1	Current NDC, 2 package rows	20250302_4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f6.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bumetanide	BUMETANIDE	Proficient Rx LP	51d5f639-5d25-4ada-8bbe-ada2386173bf	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212931 application number: ANDA212931
Bumetanide	BUMETANIDE	A-S Medication Solutions	b338ae20-fc07-4ec5-9e68-be636f75ce1a	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212931 application number: ANDA212931
Bumetanide	BUMETANIDE	Exelan Pharmaceuticals, Inc.	06745425-e7e7-4413-b9ff-22b121f0ea9a	2026-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212931 application number: ANDA212931
Bumetanide	BUMETANIDE	Solco Healthcare LLC	4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f6	2025-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212931 application number: ANDA212931 ndc (package): 43547-897-10 ndc (product): 43547-897 ndc11 (package): 43547089710

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0Y2S3XUQ5H	BUMETANIDE	28395-03-1	BUMETANIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197417	bumetanide 0.5 MG Oral Tablet	PSN	4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f6	1
197418	bumetanide 1 MG Oral Tablet	PSN	4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f6	1
197418	bumetanide 1 MG Oral Tablet	PSN	51d5f639-5d25-4ada-8bbe-ada2386173bf	1
197419	bumetanide 2 MG Oral Tablet	PSN	4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f6	1
197417	bumetanide 0.5 MG Oral Tablet	SCD	4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f6	1
197418	bumetanide 1 MG Oral Tablet	SCD	4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f6	1
197418	bumetanide 1 MG Oral Tablet	SCD	51d5f639-5d25-4ada-8bbe-ada2386173bf	1
197419	bumetanide 2 MG Oral Tablet	SCD	4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
43547-897-10	43547089710	100 TABLET in 1 BOTTLE (43547-897-10)	100 tablet	2025-03-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
bumetanide tablet, usp	Proficient Rx LP	2026-04-01	HUMAN PRESCRIPTION DRUG LABEL	1
bumetanide tablet, usp	Solco Healthcare LLC \| Appco Pharmaceutical LLC	2025-03-01	HUMAN PRESCRIPTION DRUG LABEL	1