Bumetanide

Product NDC: 0904-7016
11-digit product format: 009047016
Labeler code: 0904
Product ID: 0904-7016_f1163b02-1c88-49ab-a34a-7646b61bb50e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bumetanide
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA209724
Marketing category: ANDA
Marketing start: 2017-10-18
Substance: BUMETANIDE
Active strength: 1 mg/1
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 1.

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
A209724-001	BUMETANIDE	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2017-10-18
A209724-002	BUMETANIDE	BUMETANIDE	1MG	TABLET / ORAL	AB	2017-10-18
A209724-003	BUMETANIDE	BUMETANIDE	2MG	TABLET / ORAL	AB	2017-10-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209724-001	AB
A209724-002	AB
A209724-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A209724-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2017-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209724-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2017-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209724-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2017-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209724-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2017-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209724-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2017-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209724-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2017-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209724-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2017-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209724-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2017-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209724-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2017-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209724-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2017-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209724-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2017-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209724-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2017-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209724-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2017-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209724-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2017-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209724-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2017-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209724-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2017-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209724-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2017-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209724-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2017-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209724-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2017-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209724-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2017-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209724-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2017-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209724-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2017-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209724-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2017-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209724-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2017-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209724-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2017-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209724-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2017-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209724-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2017-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209724-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2017-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209724-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2017-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209724-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2017-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209724-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2017-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209724-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2017-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209724-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2017-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209724-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2017-10-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209724-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2017-10-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209724-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2017-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209724-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2017-10-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209724-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2017-10-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209724-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2017-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209724-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2017-10-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209724-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209724-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209724-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209724-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209724-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209724-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209724-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209724-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209724-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209724-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209724-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209724-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209724-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209724-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209724-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209724-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209724-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209724-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209724-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209724-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209724-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209724-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209724-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209724-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209724-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209724-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209724-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209724-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209724-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209724-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209724-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209724-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209724-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209724-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209724-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209724-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209724-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209724-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209724-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209724-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Bumetanide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUMETANIDE	1 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197418	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
a29cf117-00d0-4948-b646-013c8791ea39	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0904-7016-04	Bumetanide	1 in 1 BLISTER PACK	TABLET	1	6
0904-7016-04	Bumetanide	30 in 1 CARTON	TABLET	30	6
0904-7016-06	Bumetanide	50 in 1 CARTON	TABLET	50	6
0904-7016-06	Bumetanide	1 in 1 BLISTER PACK	TABLET	1	6
0904-7016-61	Bumetanide	1 in 1 BLISTER PACK	TABLET	1	6
0904-7016-61	Bumetanide	100 in 1 CARTON	TABLET	100	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7016-04	EA - Each	0904-7016	8e30d4b0-ea35-421e-bcd0-5a0f8aebe9df	1	2020-04-20
0904-7016-06	EA - Each	0904-7016	52cd1b11-0d62-4cc5-a5da-30b3dddc18ba	1	2021-01-08
0904-7016-61	EA - Each	0904-7016	05af248f-b3e1-4e5a-bb8b-abff51114350	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7016	BUMETANIDE TABLET [MAJOR PHARMACEUTICALS]	6	Current NDC, Legacy NDC, 6 package rows	20250110_a29cf117-00d0-4948-b646-013c8791ea39.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bumetanide	BUMETANIDE	Cardinal Health 107, LLC	0a5577f5-d2fe-4b0d-8245-78ee77df30fd	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209724 application number: ANDA209724
Bumetanide	BUMETANIDE	Cardinal Health 107, LLC	9bd4fcd3-3020-41f2-b112-023b5db4487d	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209724 application number: ANDA209724
Bumetanide	BUMETANIDE	AvPAK	87385a0a-e7e6-8b7f-e053-2991aa0aa21a	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209724 application number: ANDA209724
Bumetanide	BUMETANIDE	A-S Medication Solutions	c8e243c0-805a-4d81-bec9-f5be6eb9f2bc	2026-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209724 application number: ANDA209724
Bumetanide	BUMETANIDE	A-S Medication Solutions	f4326e53-5217-48d4-a089-1184442049ac	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209724 application number: ANDA209724
Bumetanide	BUMETANIDE	Major Pharmaceuticals	a29cf117-00d0-4948-b646-013c8791ea39	2025-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209724 application number: ANDA209724 ndc (product): 0904-7016
Bumetanide	BUMETANIDE	Amneal Pharmaceuticals NY LLC	9188ab17-8539-48a5-905f-ad35ab5a0b93	2023-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209724 application number: ANDA209724
Bumetanide	BUMETANIDE	A-S Medication Solutions	d85bbced-8a9e-414d-bc88-dd0b68c118df	2023-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209724 application number: ANDA209724

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
197418	bumetanide 1 MG Oral Tablet	PSN	9bd4fcd3-3020-41f2-b112-023b5db4487d	6
197418	bumetanide 1 MG Oral Tablet	PSN	a29cf117-00d0-4948-b646-013c8791ea39	6
197418	bumetanide 1 MG Oral Tablet	SCD	9bd4fcd3-3020-41f2-b112-023b5db4487d	6
197418	bumetanide 1 MG Oral Tablet	SCD	a29cf117-00d0-4948-b646-013c8791ea39	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-7016-04	00904701604	30 BLISTER PACK in 1 CARTON (0904-7016-04) / 1 TABLET in 1 BLISTER PACK	30 blister pack	2017-10-18	0000-00-00	No	No	Current
0904-7016-06	00904701606	50 BLISTER PACK in 1 CARTON (0904-7016-06) / 1 TABLET in 1 BLISTER PACK	50 blister pack	2017-10-18	0000-00-00	No	No	Current
0904-7016-61	00904701661	100 BLISTER PACK in 1 CARTON (0904-7016-61) / 1 TABLET in 1 BLISTER PACK	100 blister pack	2017-10-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bumetanide Tablets, USP (0.5 mg, 1 mg and 2 mg) Rx Only	Cardinal Health 107, LLC	2026-04-22	HUMAN PRESCRIPTION DRUG LABEL	6
Bumetanide Tablets, USP (0.5 mg, 1 mg and 2 mg) Rx Only	Major Pharmaceuticals	2025-01-07	HUMAN PRESCRIPTION DRUG LABEL	6