Application 202900

Type: ANDA
Sponsor: ZYDUS PHARMS

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
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…`

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 ndc (product): 50090-6137
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 ndc (product): 71335-1692
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): 68382-527 ndc (product): 68382-526 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 ndc (product): 70771-1026 ndc (product): 70771-1024 ndc (product): 70771-1025
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 ndc (product): 50090-6138

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
16714-831	bumetanide	bumetanide	Northstar Rx LLC	ANDA	Current
16714-831	bumetanide	bumetanide	Northstar Rx LLC	ANDA	Current
16714-832	bumetanide	bumetanide	Northstar Rx LLC	ANDA	Current
16714-832	bumetanide	bumetanide	Northstar Rx LLC	ANDA	Current
16714-833	bumetanide	bumetanide	Northstar Rx LLC	ANDA	Current
16714-833	bumetanide	bumetanide	Northstar Rx LLC	ANDA	Current
50090-5123	bumetanide	bumetanide	A-S Medication Solutions	ANDA	Current
50090-5124	bumetanide	bumetanide	A-S Medication Solutions	ANDA	Current
50090-6137	bumetanide	bumetanide	A-S Medication Solutions	ANDA	Current
50090-6138	bumetanide	bumetanide	A-S Medication Solutions	ANDA	Current
50090-6139	bumetanide	bumetanide	A-S Medication Solutions	ANDA	Current
68382-525	bumetanide	bumetanide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-525	bumetanide	bumetanide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-525	bumetanide	bumetanide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-526	bumetanide	bumetanide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-526	bumetanide	bumetanide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-526	bumetanide	bumetanide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-527	bumetanide	bumetanide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-527	bumetanide	bumetanide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-527	bumetanide	bumetanide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1024	bumetanide	bumetanide	Cadila Healthcare Limited	ANDA	Current
70771-1024	bumetanide	bumetanide	Cadila Healthcare Limited	ANDA	Current
70771-1025	bumetanide	bumetanide	Cadila Healthcare Limited	ANDA	Current
70771-1025	bumetanide	bumetanide	Cadila Healthcare Limited	ANDA	Current
70771-1026	bumetanide	bumetanide	Cadila Healthcare Limited	ANDA	Current
70771-1026	bumetanide	bumetanide	Cadila Healthcare Limited	ANDA	Current
71335-1692	bumetanide	bumetanide	Bryant Ranch Prepack	ANDA	Current
71335-1692	bumetanide	bumetanide	Bryant Ranch Prepack	ANDA	Current