bumetanide

Product NDC: 68382-525
11-digit product format: 683820525
Labeler code: 68382
Product ID: 68382-525_58b3bb3b-6096-42fd-aebc-c856c3050071
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bumetanide
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Pharmaceuticals (USA) Inc.
Application: ANDA202900
Marketing category: ANDA
Marketing start: 2018-05-01
Substance: BUMETANIDE
Active strength: .5 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
A202900-001	BUMETANIDE	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-04-30
A202900-002	BUMETANIDE	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-04-30
A202900-003	BUMETANIDE	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202900-001	AB
A202900-002	AB
A202900-003	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	A202900-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202900-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202900-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202900-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202900-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202900-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202900-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202900-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202900-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202900-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202900-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202900-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202900-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202900-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202900-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202900-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202900-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202900-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202900-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202900-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202900-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202900-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202900-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202900-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202900-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202900-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202900-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202900-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202900-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202900-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202900-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202900-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202900-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202900-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202900-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202900-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202900-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202900-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202900-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202900-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-04-30	`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	A202900-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202900-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202900-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202900-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202900-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202900-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202900-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202900-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202900-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202900-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202900-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202900-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202900-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202900-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202900-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202900-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202900-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202900-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202900-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202900-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202900-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202900-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202900-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202900-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202900-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202900-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202900-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202900-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202900-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202900-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202900-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202900-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202900-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202900-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202900-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202900-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202900-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202900-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202900-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202900-001	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	.5 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197417	Internal RxNorm lookup
197418	Internal RxNorm lookup
197419	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
525138cd-832a-41d0-84b0-83921b12bd2a	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
68382-525-01	bumetanide	100 in 1 BOTTLE	TABLET	100	5
68382-525-05	bumetanide	500 in 1 BOTTLE	TABLET	500	5
68382-525-06	bumetanide	30 in 1 BOTTLE	TABLET	30	5
68382-525-10	bumetanide	1000 in 1 BOTTLE	TABLET	1000	5
68382-525-16	bumetanide	90 in 1 BOTTLE	TABLET	90	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-525-01	EA - Each	68382-525	20945862-382f-4a17-a476-fdf0af5a24a5	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-525	BUMETANIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	5	Current NDC, Legacy NDC, 5 package rows	20231206_525138cd-832a-41d0-84b0-83921b12bd2a.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bumetanide	BUMETANIDE	A-S Medication Solutions	8b5a38cc-1e76-4821-b286-31bad3bd6913	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202900 application number: ANDA202900
bumetanide	BUMETANIDE	Bryant Ranch Prepack	a60bfe5f-d0d6-4d15-a3de-32dc68e41af3	2024-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202900 application number: ANDA202900
bumetanide	BUMETANIDE	Zydus Pharmaceuticals (USA) Inc.	525138cd-832a-41d0-84b0-83921b12bd2a	2023-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202900 application number: ANDA202900 ndc (product): 68382-525
bumetanide	BUMETANIDE	Zydus Lifesciences Limited	82eb62ca-c32b-4ff8-9f71-43219b240480	2023-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202900 application number: ANDA202900
bumetanide	BUMETANIDE	A-S Medication Solutions	cf29e436-b630-4b03-bb9b-9267ae77dc00	2023-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202900 application number: ANDA202900

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	525138cd-832a-41d0-84b0-83921b12bd2a	5
197418	bumetanide 1 MG Oral Tablet	PSN	525138cd-832a-41d0-84b0-83921b12bd2a	5
197419	bumetanide 2 MG Oral Tablet	PSN	525138cd-832a-41d0-84b0-83921b12bd2a	5
197417	bumetanide 0.5 MG Oral Tablet	SCD	525138cd-832a-41d0-84b0-83921b12bd2a	5
197418	bumetanide 1 MG Oral Tablet	SCD	525138cd-832a-41d0-84b0-83921b12bd2a	5
197419	bumetanide 2 MG Oral Tablet	SCD	525138cd-832a-41d0-84b0-83921b12bd2a	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-525-01	68382052501	100 TABLET in 1 BOTTLE (68382-525-01)	100 tablet	2018-05-01	0000-00-00	No	No	Current
68382-525-05	68382052505	500 TABLET in 1 BOTTLE (68382-525-05)	500 tablet	2018-05-01	0000-00-00	No	No	Current
68382-525-06	68382052506	30 TABLET in 1 BOTTLE (68382-525-06)	30 tablet	2018-05-01	0000-00-00	No	No	Current
68382-525-10	68382052510	1000 TABLET in 1 BOTTLE (68382-525-10)	1000 tablet	2018-05-01	0000-00-00	No	No	Current
68382-525-16	68382052516	90 TABLET in 1 BOTTLE (68382-525-16)	90 tablet	2018-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bumetanide Tablets, USP Rx only	Zydus Pharmaceuticals (USA) Inc. \| Zydus Lifesciences Limited	2023-12-05	HUMAN PRESCRIPTION DRUG LABEL	5
Bumetanide Tablets, USP Rx only	A-S Medication Solutions	2023-11-01	HUMAN PRESCRIPTION DRUG LABEL	3