NDC 59148-070-90 - BUSULFEX

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: 59148-070
Requested NDC: 59148-070-90
Package NDCs from labels: 59148-070-90, 59148-070-91
Manufacturer: Otsuka America Pharmaceutical, Inc.
Effective date: 2025-10-20
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
BUSULFEX - Otsuka America Pharmaceutical, Inc.	Otsuka America Pharmaceutical, Inc.	2025-10-20	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59148-070-91	2021-09-23	C162847	48780-1	c7ccaba7-2526-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use BUSULFEX ® safely and effectively. See full prescribing information for BUSULFEX. BUSULFEX (busulfan) Injection, for intravenous use Initial U.S. Approval: 1999
59148-070-91	2021-07-23	C162847	48780-1	c7ccaba7-2526-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use BUSULFEX ® safely and effectively. See full prescribing information for BUSULFEX. BUSULFEX (busulfan) Injection, for intravenous use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59148-070-90	BUSULFEX	10 mL in 1 VIAL	INJECTION	10	32
59148-070-90	BUSULFEX	1 in 1 CARTON	INJECTION	1	32
59148-070-91	BUSULFEX	8 in 1 CARTON	INJECTION	8	32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59148-070	BUSULFEX (BUSULFAN) INJECTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]	31	Legacy NDC, 3 package rows	20231216_5cb9d285-1803-4a99-946a-d0b239b32df6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59148-070-90	ML - Milliliter	59148-070	d3bcdc54-7e58-45d7-b97a-61a6eaeac920	1	2012-07-24
59148-070-91	ML - Milliliter	59148-070	6f9b9747-3a3c-4c03-9494-ce69ef1772f1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Busulfan	ACTIVE INGREDIENT	G1LN9045DK	BUSULFEX (BUSULFAN) INJECTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]	14
Busulfan	ACTIVE MOIETY	G1LN9045DK	BUSULFEX (BUSULFAN) INJECTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]	14
N,N-dimethylacetamide	INACTIVE INGREDIENT	JCV5VDB3HY	BUSULFEX (BUSULFAN) INJECTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]	14
Polyethylene Glycol 400	INACTIVE INGREDIENT	B697894SGQ	BUSULFEX (BUSULFAN) INJECTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]	14

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 2 of 7 · 132 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Value Health by Prodose Eye Drops	TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400	Prodose, Inc.	3fafa362-a8a6-3f91-e063-6394a90a98b3	2025-12-31	Warnings	Exact identifier unii: B697894SGQ
Signature Care Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Better Living Brands LLC	6f1f4f58-3208-4b06-9afb-c4beeed09314	2025-12-30	Warnings	Exact identifier unii: B697894SGQ
Target Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Target Corporation	6c449374-8847-4c4a-9073-1951ff31d404	2025-12-30	Warnings	Exact identifier unii: B697894SGQ
Target Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Target Corporation	ddc15dac-fbd8-42fa-80db-79f49fc6b9eb	2025-12-30	Warnings	Exact identifier unii: B697894SGQ
CVS Advanced Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	CVS Pharmacy, Inc.	f74a2fca-902c-f68a-e053-6394a90abb88	2025-12-30	Warnings	Exact identifier unii: B697894SGQ
CVS Hydration Eye Drops	POLYETYLENE GLYCOL 400, PROPYLENE GLYCOL	CVS	ecab8fa3-6575-0dde-e053-2a95a90abd61	2025-12-30	Warnings	Exact identifier unii: B697894SGQ
GoodSense Eye Drops Advanced Relief Moisturizer	DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Geiss, Derstin & Dunn, Inc.	9b34de99-13df-201a-e053-2a95a90ae559	2025-12-30	Warnings	Exact identifier unii: B697894SGQ
GoodSense Ultra Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Geiss, Destin & Dunn, Inc.	9b45ebb5-c43b-c9fb-e053-2a95a90a3411	2025-12-30	Warnings	Exact identifier unii: B697894SGQ
Discount Drug Mart Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Discount Drug Mart, Inc.	f75c2f84-a28c-5807-e053-6294a90a2295	2025-12-30	Warnings	Exact identifier unii: B697894SGQ
Discount Drug Mart Eye Drops Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Discount Drug Mart	f7fd53be-e501-d97f-e053-6394a90ad409	2025-12-30	Warnings	Exact identifier unii: B697894SGQ
Exchange Select Eye Drops Advanced Relief Moisturizer	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Army and Air Force Exchange Service	9e475240-2df1-9bee-e053-2995a90a8d4b	2025-12-30	Warnings	Exact identifier unii: B697894SGQ
Exchange Select Artificial Tears Lubricant Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Army and Air Force Exchange Service	9e478343-8ae7-823e-e053-2995a90a84ed	2025-12-30	Warnings	Exact identifier unii: B697894SGQ
Family Wellness Advanced Redness Relief Eye Drops	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL	Family Dollar Services, Inc.	fabec215-a040-3f4e-e053-6394a90ad45f	2025-12-30	Warnings	Exact identifier unii: B697894SGQ
DG Health Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Dolgencorp LLC	9c62f8a3-7cf5-40f9-e053-2a95a90afd86	2025-12-30	Warnings	Exact identifier unii: B697894SGQ
Medics Choice Eye Drops Advanced	TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE	KC Pharmaceuticals, Inc.	ab906fd8-265c-4359-a920-d626366e245c	2025-12-30	Warnings	Exact identifier unii: B697894SGQ
Medics Choice Fresh and Soothe Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	KC Pharmaceuticals, Inc.	1f65b91a-4eac-65c2-e063-6394a90a0295	2025-12-30	Warnings	Exact identifier unii: B697894SGQ
DG Health Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400	Dolgencorp LLC	9cb20c3b-bf6d-8c7c-e053-2995a90aa485	2025-12-30	Warnings	Exact identifier unii: B697894SGQ
DG Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Dolgencorp LLC	9cb27899-6c36-3c37-e053-2995a90a1d43	2025-12-30	Warnings	Exact identifier unii: B697894SGQ
Publix Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Publix Super Markets, Inc.	f7b0c3d6-0324-46c3-e053-6394a90a8241	2025-12-30	Warnings	Exact identifier unii: B697894SGQ
Publix High Performance Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Publix Super Markets, Inc.	9b402aa8-87cb-3928-e053-2995a90afa3c	2025-12-30	Warnings	Exact identifier unii: B697894SGQ

Reported adverse events (FAERS/openFDA)#

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