Application 018225

Type: NDA
Sponsor: VALIDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUMEX	BUMETANIDE	TABLET;ORAL	1MG	Yes	No
002	BUMEX	BUMETANIDE	TABLET;ORAL	0.5MG	Yes	No
003	BUMEX	BUMETANIDE	TABLET;ORAL	2MG	Yes	No

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	RLD / RS	Approval date
N018225-001	BUMEX	BUMETANIDE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28
N018225-002	BUMEX	BUMETANIDE	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28
N018225-003	BUMEX	BUMETANIDE	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1985-06-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018225-001	AB
N018225-002	AB
N018225-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018225-001	BUMEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018225-002	BUMEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018225-003	BUMEX	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1985-06-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018225-001	BUMEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018225-002	BUMEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018225-003	BUMEX	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1985-06-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018225-001	BUMEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018225-002	BUMEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018225-003	BUMEX	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1985-06-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018225-001	BUMEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018225-002	BUMEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018225-003	BUMEX	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1985-06-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018225-001	BUMEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018225-002	BUMEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018225-003	BUMEX	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1985-06-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018225-001	BUMEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018225-002	BUMEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018225-003	BUMEX	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1985-06-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018225-001	BUMEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018225-002	BUMEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018225-003	BUMEX	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1985-06-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018225-001	BUMEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018225-002	BUMEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018225-003	BUMEX	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1985-06-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018225-001	BUMEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018225-002	BUMEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018225-003	BUMEX	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1985-06-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018225-001	BUMEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018225-002	BUMEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018225-003	BUMEX	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1985-06-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018225-001	BUMEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018225-002	BUMEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018225-003	BUMEX	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1985-06-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018225-001	BUMEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018225-002	BUMEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018225-003	BUMEX	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1985-06-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018225-001	BUMEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018225-002	BUMEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018225-003	BUMEX	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1985-06-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018225-001	BUMEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	1983-02-28	`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	N018225-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018225-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018225-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018225-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018225-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018225-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018225-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018225-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018225-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018225-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018225-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018225-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018225-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018225-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018225-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018225-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018225-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018225-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018225-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018225-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018225-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018225-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018225-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018225-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018225-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018225-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018225-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018225-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018225-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018225-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018225-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018225-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018225-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018225-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018225-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018225-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018225-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018225-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018225-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018225-001	AB	1	`8072bd15b7f6…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bumetanide	BUMETANIDE	Edenbridge Pharmaceuticals LLC.	32c4372e-54ea-4fc8-b9f8-827fa4c8edd3	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018225 application number: NDA018225 ndc (product): 42799-120 ndc (product): 42799-119 ndc (product): 42799-121
Bumex	BUMETANIDE	Validus Pharmaceuticals LLC	32dfbea3-eb2b-4070-8605-57ce3e6d5a2f	2025-09-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018225 application number: NDA018225 ndc (product): 30698-631 ndc (product): 30698-632 ndc (product): 30698-630
Bumetanide	BUMETANIDE	American Health Packaging	5e9633e4-151b-4f40-885e-8f364f6f2d18	2024-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018225 application number: NDA018225 ndc (product): 60687-384 ndc (product): 60687-535

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
30698-630	Bumex	Bumetanide	Validus Pharmaceuticals LLC	NDA	Current
30698-630	Bumex	Bumetanide	Validus Pharmaceuticals LLC	NDA	Current
30698-631	Bumex	Bumetanide	Validus Pharmaceuticals LLC	NDA	Current
30698-631	Bumex	Bumetanide	Validus Pharmaceuticals LLC	NDA	Current
30698-632	Bumex	Bumetanide	Validus Pharmaceuticals LLC	NDA	Current
30698-632	Bumex	Bumetanide	Validus Pharmaceuticals LLC	NDA	Current
42799-119	Bumetanide	Bumetanide	Edenbridge	NDA AUTHORIZED	Current
42799-119	Bumetanide	Bumetanide	Edenbridge Pharmaceuticals LLC.	NDA AUTHORIZED GENERIC	Current
42799-120	Bumetanide	Bumetanide	Edenbridge	NDA AUTHORIZED	Current
42799-120	Bumetanide	Bumetanide	Edenbridge Pharmaceuticals LLC.	NDA AUTHORIZED GENERIC	Current
42799-121	Bumetanide	Bumetanide	Edenbridge	NDA AUTHORIZED	Current
42799-121	Bumetanide	Bumetanide	Edenbridge Pharmaceuticals LLC.	NDA AUTHORIZED GENERIC	Current
50090-5064	Bumetanide	Bumetanide	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-5065	Bumetanide	Bumetanide	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-5068	Bumetanide	Bumetanide	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
60687-384	Bumetanide	Bumetanide	American Health Packaging	NDA AUTHORIZED GENERIC	Current
60687-384	Bumetanide	Bumetanide	American Health Packaging	NDA AUTHORIZED GENERIC	Current
60687-384	Bumetanide	Bumetanide	American Health Packaging	NDA AUTHORIZED GENERIC	Current
60687-384	Bumetanide	Bumetanide	American Health Packaging	NDA AUTHORIZED GENERIC	Current
60687-535	Bumetanide	Bumetanide	American Health Packaging	NDA AUTHORIZED GENERIC	Current
60687-535	Bumetanide	Bumetanide	American Health Packaging	NDA AUTHORIZED GENERIC	Current
63629-7440	Bumetanide	Bumetanide	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-7440	Bumetanide	Bumetanide	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
68071-3128	Bumetanide	Bumetanide	NuCare Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68071-3128	Bumetanide	Bumetanide	NuCare Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
70518-3191	Bumetanide	Bumetanide	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
71335-0016	Bumetanide	Bumetanide	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-0016	Bumetanide	Bumetanide	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77596	SUPPL	2024-02-22
77238	SUPPL	2024-01-19
55275	SUPPL	2018-08-23
55159	SUPPL	2018-08-10
48316	SUPPL	2017-05-09
48252	SUPPL	2017-05-05
877	SUPPL	2010-01-26
11185	SUPPL	2010-01-24
14949	SUPPL	2003-06-08
40784	SUPPL	2003-03-07
20114	SUPPL	2003-03-07
33459	SUPPL	2002-10-29
14948	SUPPL	2002-10-29
11184	SUPPL	2002-10-29
876	SUPPL	2002-10-29