Bumetanide

Product NDC: 0185-0129
11-digit product format: 001850129
Labeler code: 0185
Product ID: 0185-0129_c6f31ac9-10d1-4d92-882e-836de10e1ce6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bumetanide
Dosage form: TABLET
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA074700
Marketing category: ANDA
Marketing start: 1996-11-21
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	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…`

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197417	Internal RxNorm lookup
197418	Internal RxNorm lookup
197419	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
05cb961d-ac33-4bcf-b04e-411e496c43c1	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
0185-0129-01	Bumetanide	100 in 1 BOTTLE	TABLET	100		21
0185-0129-05	Bumetanide	500 in 1 BOTTLE	TABLET	500		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0185-0129-01	EA - Each	0185-0129	38ad855f-ca78-480e-9b3d-e30f468f7486	1	2012-07-24
0185-0129-05	EA - Each	0185-0129	66be8e0f-c264-4236-ac25-b17a5f97eed9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUMETANIDE	ACTIVE INGREDIENT	0Y2S3XUQ5H	BUMETANIDE TABLET [BRYANT RANCH PREPACK]	1000
BUMETANIDE	ACTIVE MOIETY	0Y2S3XUQ5H	BUMETANIDE TABLET [BRYANT RANCH PREPACK]	1000
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	BUMETANIDE TABLET [BRYANT RANCH PREPACK]	1000
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BUMETANIDE TABLET [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUMETANIDE TABLET [BRYANT RANCH PREPACK]	1000
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BUMETANIDE TABLET [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUMETANIDE TABLET [BRYANT RANCH PREPACK]	1000
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BUMETANIDE TABLET [BRYANT RANCH PREPACK]	1000
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BUMETANIDE TABLET [BRYANT RANCH PREPACK]	1000
BUMETANIDE	ACTIVE INGREDIENT	0Y2S3XUQ5H	BUMETANIDE TABLET [EON LABS, INC.]	14
BUMETANIDE	ACTIVE MOIETY	0Y2S3XUQ5H	BUMETANIDE TABLET [EON LABS, INC.]	14
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BUMETANIDE TABLET [EON LABS, INC.]	14
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUMETANIDE TABLET [EON LABS, INC.]	14
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BUMETANIDE TABLET [EON LABS, INC.]	14
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	BUMETANIDE TABLET [EON LABS, INC.]	14
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	BUMETANIDE TABLET [EON LABS, INC.]	14
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BUMETANIDE TABLET [EON LABS, INC.]	14
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	BUMETANIDE TABLET [EON LABS, INC.]	14
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	BUMETANIDE TABLET [EON LABS, INC.]	14
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUMETANIDE TABLET [EON LABS, INC.]	14
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BUMETANIDE TABLET [EON LABS, INC.]	14
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BUMETANIDE TABLET [EON LABS, INC.]	14
BUMETANIDE	ACTIVE INGREDIENT	0Y2S3XUQ5H	BUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
BUMETANIDE	ACTIVE MOIETY	0Y2S3XUQ5H	BUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	BUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	BUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	BUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	BUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BUMETANIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0185-0129	BUMETANIDE TABLET [SANDOZ INC]	21	Current NDC, Legacy NDC, 2 package rows	20240322_05cb961d-ac33-4bcf-b04e-411e496c43c1.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 · 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
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): 0185-0129
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
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
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

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	0fb6d547-9966-4352-8974-d02ea58e6445	1014
197418	bumetanide 1 MG Oral Tablet	SCD	0fb6d547-9966-4352-8974-d02ea58e6445	1014
197418	bumetanide 1 MG Oral Tablet	PSN	056be255-5880-48e9-b160-bd5b3d82c24a	103
197418	bumetanide 1 MG Oral Tablet	SCD	056be255-5880-48e9-b160-bd5b3d82c24a	103
197418	bumetanide 1 MG Oral Tablet	PSN	b2dcdf9b-70b9-493f-99b4-fc7dcc31939a	100
197418	bumetanide 1 MG Oral Tablet	PSN	a7068f36-a863-4af0-9c82-e5394a6e7a54	100
197418	bumetanide 1 MG Oral Tablet	SCD	b2dcdf9b-70b9-493f-99b4-fc7dcc31939a	100
197418	bumetanide 1 MG Oral Tablet	SCD	a7068f36-a863-4af0-9c82-e5394a6e7a54	100
197417	bumetanide 0.5 MG Oral Tablet	PSN	05cb961d-ac33-4bcf-b04e-411e496c43c1	21
197418	bumetanide 1 MG Oral Tablet	PSN	05cb961d-ac33-4bcf-b04e-411e496c43c1	21
197419	bumetanide 2 MG Oral Tablet	PSN	05cb961d-ac33-4bcf-b04e-411e496c43c1	21
197417	bumetanide 0.5 MG Oral Tablet	SCD	05cb961d-ac33-4bcf-b04e-411e496c43c1	21
197418	bumetanide 1 MG Oral Tablet	SCD	05cb961d-ac33-4bcf-b04e-411e496c43c1	21
197419	bumetanide 2 MG Oral Tablet	SCD	05cb961d-ac33-4bcf-b04e-411e496c43c1	21
197417	bumetanide 0.5 MG Oral Tablet	PSN	d91945d7-f626-4ae2-b252-c88a38fc9ca1	4
197418	bumetanide 1 MG Oral Tablet	PSN	d91945d7-f626-4ae2-b252-c88a38fc9ca1	4
197419	bumetanide 2 MG Oral Tablet	PSN	d91945d7-f626-4ae2-b252-c88a38fc9ca1	4
197417	bumetanide 0.5 MG Oral Tablet	SCD	d91945d7-f626-4ae2-b252-c88a38fc9ca1	4
197418	bumetanide 1 MG Oral Tablet	SCD	d91945d7-f626-4ae2-b252-c88a38fc9ca1	4
197419	bumetanide 2 MG Oral Tablet	SCD	d91945d7-f626-4ae2-b252-c88a38fc9ca1	4
197418	bumetanide 1 MG Oral Tablet	PSN	ac9bfd0e-8687-464e-a8df-793868053d28	3
197418	bumetanide 1 MG Oral Tablet	SCD	ac9bfd0e-8687-464e-a8df-793868053d28	3
197418	bumetanide 1 MG Oral Tablet	PSN	805a6574-ce08-4dbd-a0f2-c423e14bb897	2
197418	bumetanide 1 MG Oral Tablet	PSN	7e47e7b1-d28a-4e12-882f-cf193b7f2697	2
197418	bumetanide 1 MG Oral Tablet	SCD	805a6574-ce08-4dbd-a0f2-c423e14bb897	2
197418	bumetanide 1 MG Oral Tablet	SCD	7e47e7b1-d28a-4e12-882f-cf193b7f2697	2
197418	bumetanide 1 MG Oral Tablet	PSN	7f9dccf8-37ff-454b-9d55-7f1d631c8483	1
197418	bumetanide 1 MG Oral Tablet	PSN	6e3d3ea1-830f-4fc6-9c56-b2ec71875dc6	1
197418	bumetanide 1 MG Oral Tablet	SCD	7f9dccf8-37ff-454b-9d55-7f1d631c8483	1
197418	bumetanide 1 MG Oral Tablet	SCD	6e3d3ea1-830f-4fc6-9c56-b2ec71875dc6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0185-0129-01	00185012901	100 TABLET in 1 BOTTLE (0185-0129-01)	100 tablet	1996-11-21	0000-00-00	No	No	Current
0185-0129-05	00185012905	500 TABLET in 1 BOTTLE (0185-0129-05)	500 tablet	1996-11-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bumetanide Tablets, USP	Bryant Ranch Prepack	2025-10-21	HUMAN PRESCRIPTION DRUG LABEL	100
Bumetanide Tablets, USP	Bryant Ranch Prepack	2025-06-26	HUMAN PRESCRIPTION DRUG LABEL	100
Bumetanide Tablets, USP	Bryant Ranch Prepack	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	103
Bumetanide Tablets, USP	Bryant Ranch Prepack	2024-07-24	HUMAN PRESCRIPTION DRUG LABEL	1014
Bumetanide Tablets, USP	Proficient Rx LP	2024-07-01	HUMAN PRESCRIPTION DRUG LABEL	1
Bumetanide Tablets, USP	Sandoz Inc	2023-06-30	HUMAN PRESCRIPTION DRUG LABEL	21
Bumetanide Tablets, USP	A-S Medication Solutions	2023-01-25	HUMAN PRESCRIPTION DRUG LABEL	1
Bumetanide Tablets, USP	Aphena Pharma Solutions - Tennessee, LLC	2019-09-30	HUMAN PRESCRIPTION DRUG LABEL	2
Bumetanide Tablets, USP	REMEDYREPACK INC.	2019-03-29	HUMAN PRESCRIPTION DRUG LABEL	1
Bumetanide Tablets, USP	Unit Dose Services	2018-04-03	HUMAN PRESCRIPTION DRUG LABEL	2
Bumetanide Tablets USP	Physicians Total Care, Inc.	2012-09-13	HUMAN PRESCRIPTION DRUG LABEL	4
Bumetanide Tablets USP	Carilion Materials Management	2011-09-21	HUMAN PRESCRIPTION DRUG LABEL	3