Bumetanide

Product NDC: 70756-081
Requested package NDC: 70756-081-51
11-digit product format: 707560081
Labeler code: 70756
Product ID: 70756-081_f131948c-e75a-4379-b9ec-875fea59a5fe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bumetanide
Dosage form: TABLET
Route: ORAL
Labeler: Lifestar Pharma LLC
Application: ANDA219291
Marketing category: ANDA
Marketing start: 2025-04-03
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 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
A219291-001	BUMETANIDE	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2025-04-03
A219291-002	BUMETANIDE	BUMETANIDE	1MG	TABLET / ORAL	AB	2025-04-03
A219291-003	BUMETANIDE	BUMETANIDE	2MG	TABLET / ORAL	AB	2025-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A219291-001	AB
A219291-002	AB
A219291-003	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	A219291-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2025-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219291-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2025-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219291-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2025-04-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219291-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2025-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219291-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2025-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219291-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2025-04-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219291-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2025-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219291-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2025-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219291-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2025-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219291-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2025-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219291-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2025-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219291-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2025-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219291-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2025-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219291-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2025-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219291-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2025-04-03	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219291-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2025-04-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219291-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2025-04-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219291-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2025-04-03	`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	A219291-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219291-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219291-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219291-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219291-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219291-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219291-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219291-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219291-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219291-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219291-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219291-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219291-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219291-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219291-003	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219291-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219291-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219291-003	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	2 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
51a344b6-acf9-4ac4-b743-1e63e3df7958	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
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
70756-081-11	Bumetanide	100 in 1 BOTTLE	TABLET	100		3
70756-081-51	Bumetanide	500 in 1 BOTTLE	TABLET	500		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70756-081-11	EA - Each	70756-081	3f9bbe93-a992-4425-a037-a3da69b595d7	1	2025-09-12
70756-081-51	EA - Each	70756-081	365ed45f-c1bc-4fec-8573-2dce97bfb49c	1	2025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70756-081	BUMETANIDE TABLET [LIFESTAR PHARMA LLC]	3	Current NDC, 2 package rows	20250410_51a344b6-acf9-4ac4-b743-1e63e3df7958.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	A-S Medication Solutions	a4dd156d-0f17-43d9-bf78-2d358c50681b	2026-05-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219291 application number: ANDA219291
Bumetanide	BUMETANIDE	First Nation Group, LLC	79b77945-74a7-4cb5-8aa0-33a7babdf6d9	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219291 application number: ANDA219291
Bumetanide	BUMETANIDE	A-S Medication Solutions	e3d38c1d-9b35-478e-bc2f-3e82b09a1538	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219291 application number: ANDA219291
Bumetanide	BUMETANIDE	Lifestar Pharma LLC	51a344b6-acf9-4ac4-b743-1e63e3df7958	2025-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219291 application number: ANDA219291 ndc (package): 70756-081-51 ndc (product): 70756-081 ndc11 (package): 70756008151

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	51a344b6-acf9-4ac4-b743-1e63e3df7958	3
197418	bumetanide 1 MG Oral Tablet	PSN	51a344b6-acf9-4ac4-b743-1e63e3df7958	3
197419	bumetanide 2 MG Oral Tablet	PSN	51a344b6-acf9-4ac4-b743-1e63e3df7958	3
197417	bumetanide 0.5 MG Oral Tablet	SCD	51a344b6-acf9-4ac4-b743-1e63e3df7958	3
197418	bumetanide 1 MG Oral Tablet	SCD	51a344b6-acf9-4ac4-b743-1e63e3df7958	3
197419	bumetanide 2 MG Oral Tablet	SCD	51a344b6-acf9-4ac4-b743-1e63e3df7958	3
197419	bumetanide 2 MG Oral Tablet	PSN	e3d38c1d-9b35-478e-bc2f-3e82b09a1538	1
197419	bumetanide 2 MG Oral Tablet	SCD	e3d38c1d-9b35-478e-bc2f-3e82b09a1538	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70756-081-51	70756008151	500 TABLET in 1 BOTTLE (70756-081-51)	500 tablet	2025-04-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bumetanide Tablets USP	A-S Medication Solutions	2026-01-14	HUMAN PRESCRIPTION DRUG LABEL	1
Bumetanide Tablets USP	Lifestar Pharma LLC \| Mankind Pharma Limited	2025-04-08	HUMAN PRESCRIPTION DRUG LABEL	3