NDC 0641-6284-01 - Bumetanide

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0641-6284
Requested NDC: 0641-6284-01
Package NDCs from labels: 0641-6284-01, 0641-6284-10
Manufacturer: Hikma Pharmaceuticals USA Inc.
Effective date: 2025-04-03
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

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

DailyMed Package Descriptions#

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

DailyMed Dashboard NDC Coverage#

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

DailyMed Billing Units#

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

DailyMed Socrata Ingredients#

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

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 50 of 56 · 1,116 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kids Cold and Cough Daytime Grape Flavor	ONION, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS WHOLE, SULFUR	Hyland's Consumer Health Inc.	e65f14cb-5a8e-0ad5-e053-2a95a90a6f5d	2022-08-16	Warnings	Exact identifier unii: 451W47IQ8X
Bumetanide	BUMETANIDE	Novadoz Pharmaceuticals LLC	387edfd4-be85-41cd-8a6d-14e6a022b5a9	2022-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1727569 rxcui: 282486 unii: 0Y2S3XUQ5H
Sterile Saline Kids Mist PediaMeds	SODIUM CHLORIDE	ASCENT CONSUMER PRODUCTS, INC.	e5c5b580-1d9f-3081-e053-2995a90a8031	2022-08-08	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Saline Kids Mist SinuCleanse Breathe	SODIUM CHLORIDE	ASCENT CONSUMER PRODUCTS, INC.	e5c5c313-046f-b0a7-e053-2a95a90a2a07	2022-08-08	Warnings	Exact identifier unii: 451W47IQ8X
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	123bd10a-90c7-499e-97f6-acf7e0f0fb4e	2022-07-29	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Herplex	ANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIA	Nashco Products LLC	fad9615f-7004-415d-9f69-ee9ff95f0067	2022-07-12	Warnings	Exact identifier unii: 451W47IQ8X
BHI Constipation	DIOSCOREA VILLOSA TUBER, SODIUM CHLORIDE, AND STRYCHNOS NUX-VOMICA SEED	MediNatura Inc	0365b75b-fee4-4c1d-89ab-c692bdd73f75	2022-07-07	Warnings	Exact identifier unii: 451W47IQ8X
Natrium Muriaticum 6X	SODIUM CHLORIDE	Seroyal USA	0ebf18de-12fe-0bc4-e054-00144ff88e88	2022-07-07	Warnings	Exact identifier unii: 451W47IQ8X
Erogetone	ARALIA QUINQUEFOLIA, BERBERIS VULGARIS, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIA	Energique, Inc.	1e872ecd-e7a5-463d-9832-47b7046096db	2022-06-28	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	Fresenius Kabi USA, LLC	f42ac50f-0ec5-4713-a4c8-99d972d90bed	2022-06-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Bumetanide	BUMETANIDE	Gland Pharma Limited	4d1ed6b2-c410-4f52-9b8a-aa256c37089e	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1727569 rxcui: 282486 unii: 0Y2S3XUQ5H
Cardioplegic Solution	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDE	Fresenius Kabi, USA, LLC	eb360dc4-88d6-4b28-9b61-bc359e16bd22	2022-05-27	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Miracle FootCream Lavender	UREA, GLYCERIN, ALOE, DISODIUM EDTA	Aloe Vera Korea Co.,Ltd.	db520c80-2a2a-5eb1-e053-2995a90a5bb4	2022-03-28	Warnings	Exact identifier unii: 7FLD91C86K
Miracle FootCream Lemon	UREA, GLYCERIN, ALOE, DISODIUM EDTA	Aloe Vera Korea Co.,Ltd.	db525c63-29fd-2033-e053-2995a90a56b9	2022-03-28	Warnings	Exact identifier unii: 7FLD91C86K
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	24a08a93-df23-474b-873e-c59ec8855f9f	2022-03-14	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Wild Horse 777 Moisturizing Nasal	SODIUM CHLORIDE	Wild Horse 777, Inc.	b0b4dadd-11fa-3dbb-e053-2995a90a2097	2022-03-14	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	cc14fafd-3dcd-4fc8-bdbd-6f355c375768	2022-02-23	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	8b44bfd3-70a4-4b47-bc7b-590f63b8cc75	2022-02-15	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
ACNE HP	CARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINC	Natural Creations, Inc.	b2368ab6-e233-4473-99fa-86e1fbc2a879	2022-02-14	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.