Bumetanide

Product NDC: 0832-0540
11-digit product format: 008320540
Labeler code: 0832
Product ID: 0832-0540_a2d6a760-9f0b-4ef7-afa1-9dca807dce3c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUMETANIDE
Dosage form: TABLET
Route: ORAL
Labeler: Upsher-Smith Laboratories, LLC
Application: ANDA209916
Marketing category: ANDA
Marketing start: 2018-01-30
Marketing end: 0000-00-00
Substance: BUMETANIDE
Active strength: 1 mg/1
Pharmacologic classes: Loop Diuretic [EPC],Increased Diuresis at Loop of Henle [PE]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0832-0540		D	Discontinued by firm		2026-10-12
excluded package	package	0832-0540	0832-0540-11	D	Discontinued by firm		2026-10-12

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
A209916-001	BUMETANIDE	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23
A209916-002	BUMETANIDE	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23
A209916-003	BUMETANIDE	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209916-001	AB
A209916-002	AB
A209916-003	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209916-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209916-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209916-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209916-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209916-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209916-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209916-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209916-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209916-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209916-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209916-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209916-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209916-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209916-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209916-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209916-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209916-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209916-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209916-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209916-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209916-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209916-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209916-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209916-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209916-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209916-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209916-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209916-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209916-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209916-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209916-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209916-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209916-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209916-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209916-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209916-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209916-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209916-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209916-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209916-002	AB	1	`3f01610625f2…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0832-0540-11	Bumetanide	100 in 1 BOTTLE	TABLET	100		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0832-0540-11	EA - Each	0832-0540	a563eeeb-9ff0-4bba-a8c2-f589d47ebb95	1	2018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0832-0540	BUMETANIDE TABLET [UPSHER-SMITH LABORATORIES, LLC]	6	Legacy NDC, 1 package rows	20240301_ff5dc8c6-b2f2-41d3-8e56-a953aa721b59.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bumetanide	BUMETANIDE	A-S Medication Solutions	dfa1f77d-8209-48e9-a6c7-d3b4725a97db	2024-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209916 application number: ANDA209916

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	ff5dc8c6-b2f2-41d3-8e56-a953aa721b59	7
197418	bumetanide 1 MG Oral Tablet	PSN	ff5dc8c6-b2f2-41d3-8e56-a953aa721b59	7
197419	bumetanide 2 MG Oral Tablet	PSN	ff5dc8c6-b2f2-41d3-8e56-a953aa721b59	7
197417	bumetanide 0.5 MG Oral Tablet	SCD	ff5dc8c6-b2f2-41d3-8e56-a953aa721b59	7
197418	bumetanide 1 MG Oral Tablet	SCD	ff5dc8c6-b2f2-41d3-8e56-a953aa721b59	7
197419	bumetanide 2 MG Oral Tablet	SCD	ff5dc8c6-b2f2-41d3-8e56-a953aa721b59	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0832-0540-11	00832054011	100 TABLET in 1 BOTTLE (0832-0540-11)	100 tablet	2018-01-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bumetanide Tablets, USP	Upsher-Smith Laboratories, LLC	2025-07-15	HUMAN PRESCRIPTION DRUG LABEL	7