bumetanide

Product NDC: 50090-6139
11-digit product format: 500906139
Labeler code: 50090
Product ID: 50090-6139_5e0baf97-c202-49cb-814c-76d9ec48696a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bumetanide
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA202900
Marketing category: ANDA
Marketing start: 2018-05-01
Marketing end: 0000-00-00
Substance: BUMETANIDE
Active strength: 1 mg/1
Pharmacologic classes: Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50090-6139		D	Discontinued by firm		2026-08-07
excluded package	package	50090-6139	50090-6139-0	D	Discontinued by firm		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-6139-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-6139-0	`f5e01cc5f278…`	`a2eaf40c39c3…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-6139-0	EA - Each	50090-6139	1864bd34-45a6-48c6-ae48-3946b30dab2f	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6139	BUMETANIDE TABLET [A-S MEDICATION SOLUTIONS]	3	Legacy NDC	20231102_0f2894f8-91dd-4e8c-9bbb-c9b6f021fd02.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-6139-0	50090613900	90 TABLET in 1 BOTTLE (50090-6139-0)	90 tablet	2022-10-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bumetanide Tablets, USP Rx only	A-S Medication Solutions	2023-11-01	HUMAN PRESCRIPTION DRUG LABEL	3