Application 209724

Type: ANDA
Sponsor: AMNEAL PHARMS CO

Application Products#

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

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 ndc (product): 55154-4345
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 ndc (product): 55154-3572
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 ndc (product): 50268-132 ndc (product): 50268-130 ndc (product): 50268-131
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 ndc (product): 50090-5663
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 ndc (product): 50090-5664
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 ndc (product): 69238-1491 ndc (product): 69238-1490 ndc (product): 69238-1489
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 ndc (product): 50090-5666

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 47 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8393	Bumetanide	Bumetanide	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8394	Bumetanide	Bumetanide	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0904-7016	Bumetanide	Bumetanide	Major Pharmaceuticals	ANDA	Current
0904-7016	Bumetanide	Bumetanide	Major Pharmaceuticals	ANDA	Current
0904-7016	Bumetanide	Bumetanide	Major Pharmaceuticals	ANDA	Current
0904-7016	Bumetanide	Bumetanide	Major Pharmaceuticals	ANDA	Current
50090-5663	Bumetanide	Bumetanide	A-S Medication Solutions	ANDA	Current
50090-5664	Bumetanide	Bumetanide	A-S Medication Solutions	ANDA	Current
50090-5666	Bumetanide	Bumetanide	A-S Medication Solutions	ANDA	Current
50268-130	Bumetanide	Bumetanide	AvPAK	ANDA	Current
50268-130	Bumetanide	Bumetanide	AvPAK	ANDA	Current
50268-131	Bumetanide	Bumetanide	AvPAK	ANDA	Current
50268-131	Bumetanide	Bumetanide	AvPAK	ANDA	Current
50268-132	Bumetanide	Bumetanide	AvPAK	ANDA	Current
50268-132	Bumetanide	Bumetanide	AvPAK	ANDA	Current
55154-3572	Bumetanide	Bumetanide	Cardinal Health	ANDA	Current
55154-4345	Bumetanide	Bumetanide	Cardinal Health	ANDA	Current
55154-4345	Bumetanide	Bumetanide	Cardinal Health 107, LLC	ANDA	Current
55154-4345	Bumetanide	Bumetanide	Cardinal Health	ANDA	Current
68071-4330	Bumetanide	Bumetanide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4330	Bumetanide	Bumetanide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4330	Bumetanide	Bumetanide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4350	Bumetanide	Bumetanide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4350	Bumetanide	Bumetanide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4350	Bumetanide	Bumetanide	NuCare Pharmaceuticals,Inc.	ANDA	Current
69238-1489	Bumetanide	Bumetanide	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1489	Bumetanide	Bumetanide	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1489	Bumetanide	Bumetanide	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1489	Bumetanide	Bumetanide	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1489	Bumetanide	Bumetanide	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1490	Bumetanide	Bumetanide	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1490	Bumetanide	Bumetanide	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1490	Bumetanide	Bumetanide	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1490	Bumetanide	Bumetanide	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1490	Bumetanide	Bumetanide	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1491	Bumetanide	Bumetanide	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1491	Bumetanide	Bumetanide	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1491	Bumetanide	Bumetanide	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1491	Bumetanide	Bumetanide	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1491	Bumetanide	Bumetanide	Amneal Pharmaceuticals NY LLC	ANDA	Current
70518-2678	Bumetanide	Bumetanide	REMEDYREPACK INC.	ANDA	Current
70518-2678	Bumetanide	Bumetanide	REMEDYREPACK INC.	ANDA	Current
70518-2678	Bumetanide	Bumetanide	REMEDYREPACK INC.	ANDA	Current
71335-1201	Bumetanide	Bumetanide	Bryant Ranch Prepack	ANDA	Current
71335-1201	Bumetanide	Bumetanide	Bryant Ranch Prepack	ANDA	Current
71335-1201	Bumetanide	Bumetanide	Bryant Ranch Prepack	ANDA	Current
71335-1246	Bumetanide	Bumetanide	Bryant Ranch Prepack	ANDA	Current