Bumetanide

Product NDC: 0781-8160
11-digit product format: 007818160
Labeler code: 0781
Product ID: 0781-8160_8914d8bf-61b7-4cd2-a8ef-7e1c5df37828
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bumetanide
Dosage form: TABLET
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA074700
Marketing category: ANDA
Marketing start: 2026-06-03
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: 2027-12-31
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	RLD / RS	Approval date
A074700-001	BUMETANIDE	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21
A074700-002	BUMETANIDE	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21
A074700-003	BUMETANIDE	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21

Therapeutic equivalence codes#

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

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

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A074700-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074700-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074700-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074700-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074700-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074700-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074700-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074700-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074700-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074700-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074700-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074700-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074700-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074700-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074700-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074700-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074700-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074700-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074700-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074700-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074700-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074700-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074700-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074700-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074700-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074700-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074700-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074700-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074700-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074700-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074700-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074700-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074700-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074700-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074700-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074700-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074700-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074700-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074700-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074700-001	AB	1	`301d65b070ca…`

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: 2027-12-31

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
8914d8bf-61b7-4cd2-a8ef-7e1c5df37828	Available on FDA.report

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bumetanide	BUMETANIDE	REMEDYREPACK INC.	0fb78afc-d8bc-4ae8-8c0a-6d9c6f7a22c5	2026-09-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	Sandoz Inc	8914d8bf-61b7-4cd2-a8ef-7e1c5df37828	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700 ndc (product): 0781-8160
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	12b9489a-b16b-4504-a660-e66fd5261069	2025-11-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	b2dcdf9b-70b9-493f-99b4-fc7dcc31939a	2025-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	6b5450f2-ae91-48b6-ad83-261bdfcf47ac	2025-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	a7068f36-a863-4af0-9c82-e5394a6e7a54	2025-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	056be255-5880-48e9-b160-bd5b3d82c24a	2025-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	80fe034e-01b7-438e-8378-44fafb7a1d94	2025-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	0fb6d547-9966-4352-8974-d02ea58e6445	2024-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	Proficient Rx LP	6e3d3ea1-830f-4fc6-9c56-b2ec71875dc6	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	f6f12a41-ae6d-4ce6-9bb1-e32679af665f	2024-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	Sandoz Inc	05cb961d-ac33-4bcf-b04e-411e496c43c1	2023-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	A-S Medication Solutions	7f9dccf8-37ff-454b-9d55-7f1d631c8483	2023-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	A-S Medication Solutions	f6ff0d37-c67d-4b9f-8b62-5deda9783c28	2023-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	A-S Medication Solutions	8bed63fb-91ec-4132-ac0a-16c4c6f58d95	2023-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	Aphena Pharma Solutions - Tennessee, LLC	7e47e7b1-d28a-4e12-882f-cf193b7f2697	2019-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0781-8160-01	00781816001	100 TABLET in 1 BOTTLE (0781-8160-01)	100 tablet	2026-06-03	No	No	Current
0781-8160-05	00781816005	500 TABLET in 1 BOTTLE (0781-8160-05)	500 tablet	2026-06-03	No	No	Current