Bumetanide

Product NDC: 72572-211
Requested package NDC: 72572-211-10
11-digit product format: 725720211
Labeler code: 72572
Product ID: 72572-211_b178f54e-11e4-48a8-a6eb-845bbd89de1f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bumetanide
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Civica, Inc.
Application: ANDA074441
Marketing category: ANDA
Marketing start: 2026-08-01
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
A074441-001	BUMETANIDE	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP		1995-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074441-001	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION		1995-01-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION		1995-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION		1995-01-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION		1995-01-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION		1995-01-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION		1995-01-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION		1995-01-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION		1995-01-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION		1995-01-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION		1995-01-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074441-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	1995-01-27	`f41ea6bd6efb…`

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	A074441-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074441-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074441-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074441-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074441-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074441-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074441-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074441-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074441-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074441-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074441-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074441-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074441-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074441-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074441-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074441-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074441-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074441-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074441-001	AP	1	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074441-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074441-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074441-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074441-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074441-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074441-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074441-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074441-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074441-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074441-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074441-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074441-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074441-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A074441-001	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: 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 · 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
4a9229c8-89ba-423e-8e36-f56bc329ed38	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bumetanide	BUMETANIDE	Sagent Pharmaceuticals	c38a404d-a919-4a2c-9fbb-d0655dee9516	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074441 application number: ANDA074441
Bumetanide	BUMETANIDE	Civica, Inc.	4a9229c8-89ba-423e-8e36-f56bc329ed38	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074441 application number: ANDA074441 ndc (package): 72572-211-10 ndc (product): 72572-211 ndc11 (package): 72572021110

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
72572-211-10	72572021110	10 VIAL in 1 CARTON (72572-211-10) / 10 mL in 1 VIAL (72572-211-01)	10 vial	2026-08-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bumetanide Injection, USP (For Intravenous or Intramuscular Use)	Civica, Inc.	2026-07-10	HUMAN PRESCRIPTION DRUG LABEL	1