Application 074700

Type: ANDA
Sponsor: SANDOZ

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	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	RLD / RS	Approval date
A074700-001	BUMETANIDE	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21
A074700-002	BUMETANIDE	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21
A074700-003	BUMETANIDE	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074700-001	AB
A074700-002	AB
A074700-003	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	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074700-002	BUMETANIDE	1MG	TABLET / ORAL	AB		1996-11-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074700-003	BUMETANIDE	2MG	TABLET / ORAL	AB	RS	1996-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074700-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB		1996-11-21	`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	A074700-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074700-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074700-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074700-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074700-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074700-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074700-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074700-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074700-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074700-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074700-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074700-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074700-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074700-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074700-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074700-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074700-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074700-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074700-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074700-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074700-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074700-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074700-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074700-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074700-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074700-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074700-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074700-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074700-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074700-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074700-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074700-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074700-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074700-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074700-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074700-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074700-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074700-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074700-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074700-001	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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bumetanide	BUMETANIDE	Sandoz Inc	8914d8bf-61b7-4cd2-a8ef-7e1c5df37828	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	12b9489a-b16b-4504-a660-e66fd5261069	2025-11-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	b2dcdf9b-70b9-493f-99b4-fc7dcc31939a	2025-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	6b5450f2-ae91-48b6-ad83-261bdfcf47ac	2025-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	REMEDYREPACK INC.	0fb78afc-d8bc-4ae8-8c0a-6d9c6f7a22c5	2025-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	a7068f36-a863-4af0-9c82-e5394a6e7a54	2025-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	056be255-5880-48e9-b160-bd5b3d82c24a	2025-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	80fe034e-01b7-438e-8378-44fafb7a1d94	2025-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	0fb6d547-9966-4352-8974-d02ea58e6445	2024-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700 ndc (product): 63629-4968
Bumetanide	BUMETANIDE	Proficient Rx LP	6e3d3ea1-830f-4fc6-9c56-b2ec71875dc6	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	f6f12a41-ae6d-4ce6-9bb1-e32679af665f	2024-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	Sandoz Inc	05cb961d-ac33-4bcf-b04e-411e496c43c1	2023-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700 ndc (product): 0185-0128 ndc (product): 0185-0130 ndc (product): 0185-0129
Bumetanide	BUMETANIDE	A-S Medication Solutions	7f9dccf8-37ff-454b-9d55-7f1d631c8483	2023-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700
Bumetanide	BUMETANIDE	A-S Medication Solutions	f6ff0d37-c67d-4b9f-8b62-5deda9783c28	2023-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700 ndc (product): 50090-6308
Bumetanide	BUMETANIDE	A-S Medication Solutions	8bed63fb-91ec-4132-ac0a-16c4c6f58d95	2023-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700 ndc (product): 50090-6304
Bumetanide	BUMETANIDE	Aphena Pharma Solutions - Tennessee, LLC	7e47e7b1-d28a-4e12-882f-cf193b7f2697	2019-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074700 application number: ANDA074700 ndc (product): 43353-288

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-0128	Bumetanide	Bumetanide	Eon Labs, Inc.	ANDA	Current
0185-0128	Bumetanide	Bumetanide	Eon Labs, Inc.	ANDA	Current
0185-0128	Bumetanide	Bumetanide	Eon Labs, Inc.	ANDA	Current
0185-0129	Bumetanide	Bumetanide	Eon Labs, Inc.	ANDA	Current
0185-0129	Bumetanide	Bumetanide	Eon Labs, Inc.	ANDA	Current
0185-0129	Bumetanide	Bumetanide	Eon Labs, Inc.	ANDA	Current
0185-0130	Bumetanide	Bumetanide	Eon Labs, Inc.	ANDA	Current
0185-0130	Bumetanide	Bumetanide	Eon Labs, Inc.	ANDA	Current
0185-0130	Bumetanide	Bumetanide	Eon Labs, Inc.	ANDA	Current
43353-288	Bumetanide	Bumetanide	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-288	Bumetanide	Bumetanide	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-292	Bumetanide	Bumetanide	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-6304	Bumetanide	Bumetanide	A-S Medication Solutions	ANDA	Current
50090-6308	Bumetanide	Bumetanide	A-S Medication Solutions	ANDA	Current
50436-0129	Bumetanide	Bumetanide	Unit Dose Services	ANDA	Current
63629-4968	Bumetanide	Bumetanide	Bryant Ranch Prepack	ANDA	Current
63629-4968	Bumetanide	Bumetanide	Bryant Ranch Prepack	ANDA	Current
63629-4968	Bumetanide	Bumetanide	Bryant Ranch Prepack	ANDA	Current
63629-4968	Bumetanide	Bumetanide	Bryant Ranch Prepack	ANDA	Current
68071-3023	Bumetanide	Bumetanide	NuCare Pharmaceuticals, Inc..	ANDA	Current
68071-3023	Bumetanide	Bumetanide	NuCare Pharmaceuticals, Inc..	ANDA	Current
68151-1744	Bumetanide	Bumetanide	Carilion Materials Management	ANDA	Current
70518-1991	Bumetanide	Bumetanide	REMEDYREPACK INC.	ANDA	Current