Bumetanide

Product NDC: 70518-4385
11-digit product format: 705184385
Labeler code: 70518
Product ID: 70518-4385_396ba025-0ad2-40dc-e063-6294a90a7d6f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bumetanide
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA213942
Marketing category: ANDA
Marketing start: 2025-07-06
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: 2026-12-31
Current FDA listing: 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	Approval date
A213942-001	BUMETANIDE	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2024-12-27
A213942-002	BUMETANIDE	BUMETANIDE	1MG	TABLET / ORAL	AB	2024-12-27
A213942-003	BUMETANIDE	BUMETANIDE	2MG	TABLET / ORAL	AB	2024-12-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213942-001	AB
A213942-002	AB
A213942-003	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.

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	A213942-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2024-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213942-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2024-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213942-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2024-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213942-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2024-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213942-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2024-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213942-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2024-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213942-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2024-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213942-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2024-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213942-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2024-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213942-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2024-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213942-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2024-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213942-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2024-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213942-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2024-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213942-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2024-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213942-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2024-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213942-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2024-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213942-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2024-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213942-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2024-12-27	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213942-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2024-12-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213942-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2024-12-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213942-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2024-12-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213942-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213942-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213942-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213942-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213942-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213942-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213942-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213942-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213942-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213942-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213942-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213942-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213942-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213942-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213942-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213942-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213942-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213942-003	AB	1	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213942-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213942-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213942-003	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Bumetanide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUMETANIDE	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0Y2S3XUQ5H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197418	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
de008936-e8a3-4e65-bb6a-d925b68a5f50	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1d3f2f0a-cce7-32fe-77bf-6ee61839e736	Product name	9	20260113
601d9750-f415-d9d9-619c-0a87b4d3f237	Product name	3	20250331
1d3f2f0a-cce7-32fe-77bf-6ee61839e736	Product name	2	20171211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-4385-0	Bumetanide	90 in 1 BOTTLE, PLASTIC	TABLET	90		2

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	NCS HealthCare of KY, LLC dba Vangard Labs	fa4e5faf-c91a-457b-bd2b-14a9add51ac8	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213942 application number: ANDA213942
Bumetanide	BUMETANIDE	Advagen Pharma Limited	94078edd-b9c0-449e-baaf-a9afceccb407	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213942 application number: ANDA213942
Bumetanide	BUMETANIDE	A-S Medication Solutions	14e92f79-2c7b-4ab9-844f-e7bd1964f8b2	2025-11-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213942 application number: ANDA213942
Bumetanide	BUMETANIDE	REMEDYREPACK INC.	c5d87c7c-3d03-4a9a-8f07-382371c55169	2025-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213942 application number: ANDA213942
Bumetanide	BUMETANIDE	REMEDYREPACK INC.	de008936-e8a3-4e65-bb6a-d925b68a5f50	2025-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213942 application number: ANDA213942 ndc (product): 70518-4385

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0Y2S3XUQ5H	BUMETANIDE	28395-03-1	BUMETANIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197418	bumetanide 1 MG Oral Tablet	PSN	de008936-e8a3-4e65-bb6a-d925b68a5f50	2
197418	bumetanide 1 MG Oral Tablet	SCD	de008936-e8a3-4e65-bb6a-d925b68a5f50	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4385-0	70518438500	90 TABLET in 1 BOTTLE, PLASTIC (70518-4385-0)	90 tablet	2025-07-06	No	No	Current