Bumetanide

Product NDC: 72205-102
Requested package NDC: 72205-102-07
11-digit product format: 722050102
Labeler code: 72205
Product ID: 72205-102_387edfd4-be85-41cd-8a6d-14e6a022b5a9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bumetanide
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Novadoz Pharmaceuticals LLC
Application: ANDA215364
Marketing category: ANDA
Marketing start: 2022-08-06
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: 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A215364-001	BUMETANIDE	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP		2022-08-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215364-001	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.

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	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215364-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2022-08-04	`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	A215364-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215364-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215364-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215364-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215364-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215364-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215364-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215364-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215364-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215364-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215364-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215364-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215364-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215364-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215364-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215364-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215364-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215364-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215364-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215364-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215364-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215364-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215364-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215364-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215364-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215364-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215364-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215364-001	AP	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215364-001	AP	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	.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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
282486	Internal RxNorm lookup
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
387edfd4-be85-41cd-8a6d-14e6a022b5a9	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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72205-102-01	Bumetanide	10 mL in 1 VIAL	INJECTION	10		1
72205-102-07	Bumetanide	10 in 1 CARTON	INJECTION	10		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72205-102-01	ML - Milliliter	72205-102	d798b21f-9dc6-48f7-a0b0-1d04ae7cbacc	1	2022-12-07
72205-102-07	ML - Milliliter	72205-102	a9ccd4bd-25ea-4699-9297-49225d6e91b2	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72205-102	BUMETANIDE INJECTION [NOVADOZ PHARMACEUTICALS LLC]	1	Current NDC, Legacy NDC, 2 package rows	20220811_387edfd4-be85-41cd-8a6d-14e6a022b5a9.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	Bryant Ranch Prepack	43ab2dd6-39ba-4a53-aa84-d7975038ef43	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215364 application number: ANDA215364
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	37179b2d-6589-40d8-8121-7561a6791d38	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215364 application number: ANDA215364
Bumetanide	BUMETANIDE	Cardinal Health 107, LLC	68f18d36-ffc2-4481-9286-914cfcf573a0	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215364 application number: ANDA215364
Bumetanide	BUMETANIDE	Novadoz Pharmaceuticals LLC	387edfd4-be85-41cd-8a6d-14e6a022b5a9	2022-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215364 application number: ANDA215364 ndc (package): 72205-102-07 ndc (product): 72205-102 ndc11 (package): 72205010207

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
282486	bumetanide 0.25 MG/ML Injectable Solution	PSN	37179b2d-6589-40d8-8121-7561a6791d38	100
282486	bumetanide 0.25 MG/ML Injectable Solution	SCD	37179b2d-6589-40d8-8121-7561a6791d38	100
282486	bumetanide 0.25 MG/ML Injectable Solution	PSN	387edfd4-be85-41cd-8a6d-14e6a022b5a9	1
1727569	bumetanide 1 MG in 4 ML Injection	PSN	387edfd4-be85-41cd-8a6d-14e6a022b5a9	1
1727569	4 ML bumetanide 0.25 MG/ML Injection	SCD	387edfd4-be85-41cd-8a6d-14e6a022b5a9	1
282486	bumetanide 0.25 MG/ML Injectable Solution	SCD	387edfd4-be85-41cd-8a6d-14e6a022b5a9	1
1727569	bumetanide 1 MG per 4 ML Injection	SY	387edfd4-be85-41cd-8a6d-14e6a022b5a9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72205-102-07	72205010207	10 VIAL in 1 CARTON (72205-102-07) / 10 mL in 1 VIAL (72205-102-01)	10 vial	2022-08-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bumetanide Injection, USP Rx Only	Bryant Ranch Prepack	2026-05-06	HUMAN PRESCRIPTION DRUG LABEL	100
Bumetanide Injection, USP Rx Only	Novadoz Pharmaceuticals LLC \| MSN LABORATORIES PRIVATE LIMITED	2022-08-09	Human Prescription Drug Label	1