Bumetanide

Product NDC: 0641-6284
11-digit product format: 006416284
Labeler code: 0641
Product ID: 0641-6284_cbf46236-4090-445f-ad19-fd9d767deecc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bumetanide
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA079196
Marketing category: ANDA
Marketing start: 2008-04-30
Substance: BUMETANIDE
Active strength: .25 mg/mL
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

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
BUMETANIDE	.25 mg/mL

Field, Values table
Field	Values
Unii	0Y2S3XUQ5H
Rxcui	282486, 1727569

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-6284-01	Bumetanide	4 mL in 1 VIAL	INJECTION	4		7
0641-6284-10	Bumetanide	10 in 1 CARTON	INJECTION	10		7

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6284-01	ML - Milliliter	0641-6284	46ee6267-ada1-4dfa-9e82-d9358593206f	1	2025-05-14
0641-6284-10	ML - Milliliter	0641-6284	44c5387e-3f80-4902-86d6-0f1160ffabb2	1	2025-05-14

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUMETANIDE	ACTIVE INGREDIENT	0Y2S3XUQ5H	BUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
BUMETANIDE	ACTIVE MOIETY	0Y2S3XUQ5H	BUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
AMMONIUM ACETATE	INACTIVE INGREDIENT	RRE756S6Q2	BUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	BUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	BUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	BUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	BUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6284	BUMETANIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]	7	Current NDC, 2 package rows	20250406_b5a68154-8003-4b80-81e2-e926524fb72c.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
282486	bumetanide 0.25 MG/ML Injectable Solution	PSN	b5a68154-8003-4b80-81e2-e926524fb72c	7
1727569	bumetanide 1 MG in 4 ML Injection	PSN	b5a68154-8003-4b80-81e2-e926524fb72c	7
1727569	4 ML bumetanide 0.25 MG/ML Injection	SCD	b5a68154-8003-4b80-81e2-e926524fb72c	7
282486	bumetanide 0.25 MG/ML Injectable Solution	SCD	b5a68154-8003-4b80-81e2-e926524fb72c	7
1727569	bumetanide 1 MG per 4 ML Injection	SY	b5a68154-8003-4b80-81e2-e926524fb72c	7

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0641-6284-01	00641628401	4 mL in 1 VIAL	4 ml				Historical
0641-6284-10	00641628410	10 VIAL in 1 CARTON (0641-6284-10) / 4 mL in 1 VIAL (0641-6284-01)	10 vial	2008-04-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bumetanide Injection, USP Rx ONLY NOVAPLUS®	Hikma Pharmaceuticals USA Inc.	2025-04-03	HUMAN PRESCRIPTION DRUG LABEL	7