Bumetanide

Product NDC: 55154-5131
11-digit product format: 551545131
Labeler code: 55154
Product ID: 55154-5131_e7c3c63e-3aea-4b33-b165-7c7449359674
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bumetanide
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Cardinal Health 107, LLC
Application: ANDA079196
Marketing category: ANDA
Marketing start: 2026-07-01
Substance: BUMETANIDE
Active strength: .25 mg/mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A079196-001	BUMETANIDE	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079196-001	AP

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 2 · 43 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	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079196-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	RS	2008-04-30	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A079196-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079196-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079196-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079196-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079196-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079196-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079196-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079196-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079196-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079196-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079196-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079196-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079196-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079196-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079196-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079196-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079196-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079196-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079196-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079196-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079196-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079196-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079196-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079196-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079196-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079196-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079196-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079196-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079196-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079196-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079196-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079196-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079196-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079196-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079196-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079196-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079196-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079196-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079196-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079196-001	AP	1	`f41ea6bd6efb…`

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	.25 mg/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1727569	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
e7c3c63e-3aea-4b33-b165-7c7449359674	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bumetanide	BUMETANIDE	Hikma Pharmaceuticals USA Inc.	681b5e9d-e2c7-4f29-aaad-e06d4a528c11	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079196 application number: ANDA079196
Bumetanide	BUMETANIDE	Cardinal Health 107, LLC	e7c3c63e-3aea-4b33-b165-7c7449359674	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079196 application number: ANDA079196 ndc (product): 55154-5131
Bumetanide	BUMETANIDE	Hikma Pharmaceuticals USA Inc.	b5a68154-8003-4b80-81e2-e926524fb72c	2025-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079196 application number: ANDA079196
BUMETANIDE	BUMETANIDE	HF Acquisition Co LLC, DBA HealthFirst	9bd7a71e-0e78-dae7-e053-2995a90ad110	2025-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079196 application number: ANDA079196
Bumetanide	BUMETANIDE	Civica, Inc.	308c690f-c2bd-4c32-8728-42ec95425f77	2023-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079196 application number: ANDA079196

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
55154-5131-5	55154513105	5 VIAL in 1 BAG (55154-5131-5) / 4 mL in 1 VIAL	5 vial	2026-07-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bumetanide Injection, USP Rx Only	Cardinal Health 107, LLC	2026-07-01	HUMAN PRESCRIPTION DRUG LABEL	1