FDA.reportPublic FDA data

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
2026-10-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BUSULFEX - Otsuka America Pharmaceutical, Inc.Otsuka America Pharmaceutical, Inc.2026-10-14HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2021-09-23These 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
2021-09-23These 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
2021-07-23These 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
2021-07-23These 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 NDCProductDescriptionFormQuantityStrengthSPL version
59148-070-90BUSULFEX10 mL in 1 VIALINJECTION1032
59148-070-90BUSULFEX1 in 1 CARTONINJECTION132
59148-070-91BUSULFEX8 in 1 CARTONINJECTION832

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59148-070BUSULFEX (BUSULFAN) INJECTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]31Legacy NDC, 3 package rows20231216_5cb9d285-1803-4a99-946a-d0b239b32df6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59148-070-90ML - Milliliter59148-070d3bcdc54-7e58-45d7-b97a-61a6eaeac92012012-07-24
59148-070-91ML - Milliliter59148-0706f9b9747-3a3c-4c03-9494-ce69ef1772f112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BusulfanACTIVE INGREDIENTG1LN9045DKBUSULFEX (BUSULFAN) INJECTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]14
BusulfanACTIVE MOIETYG1LN9045DKBUSULFEX (BUSULFAN) INJECTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]14
N,N-dimethylacetamideINACTIVE INGREDIENTJCV5VDB3HYBUSULFEX (BUSULFAN) INJECTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]14
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQBUSULFEX (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 3 of 7 · 132 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Health Mart Lubricating TearsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLCc8be678f-2b4a-4d39-9cb4-910d36d721742025-12-30WarningsExact identifier
unii: B697894SGQ
Core Values Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Liberty Procurement Co. Inc.f8285f68-c40c-19a8-e053-6394a90aacad2025-12-30WarningsExact identifier
unii: B697894SGQ
Core Values Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDELiberty Procurement Co., Inc.f76dfeca-4e86-0b5d-e053-6294a90a29b92025-12-30WarningsExact identifier
unii: B697894SGQ
Harris Teeter Eye Drops Artificial TearsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Harris Teeter, LLC.f82957d9-c4ad-a914-e053-6294a90aac502025-12-30WarningsExact identifier
unii: B697894SGQ
Best Choice Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEValu Merchandisers, Co.f7491a17-8035-5a3c-e053-6294a90a615c2025-12-30WarningsExact identifier
unii: B697894SGQ
Winco Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLWinCo Foods, LLCf10778c8-14fe-4852-8b73-42db502fd2bc2025-12-30WarningsExact identifier
unii: B697894SGQ
Harris Teeter Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHarris Teeter, LLCf76e2831-5c6c-7a62-e053-6294a90a937b2025-12-30WarningsExact identifier
unii: B697894SGQ
Foster and Thrive Lubricating Tears Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC0042337b-c22a-157a-e063-6394a90a202e2025-12-30WarningsExact identifier
unii: B697894SGQ
CVS Lubricant Eye Drops OriginalPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCVSbb1ad35a-79ea-639f-e053-2995a90a96f32025-12-30WarningsExact identifier
unii: B697894SGQ
Foster and Thrive Advanced Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCLStrategic Sourcing Services LLC0019cd99-b245-2ffc-e063-6294a90a9f272025-12-30WarningsExact identifier
unii: B697894SGQ
CVS Multi-Symptom Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATECVS Pharmacy, Inc.be3d7855-cc66-ace8-e053-2a95a90ab8f42025-12-30WarningsExact identifier
unii: B697894SGQ
Foster and Thrive Dry Eye ReliefPOLYETHYLENE GLYCOL 400Strategic Sourcing Services LLC0018ade9-5856-db6c-e063-6394a90a2ccf2025-12-30WarningsExact identifier
unii: B697894SGQ
Foster and Thrive Long Lasting Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC00546df0-17d8-0e3c-e063-6294a90ae7b22025-12-30WarningsExact identifier
unii: B697894SGQ
Meijer Multi-Symptom ReliefPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEMeijer, Inc.e7a5677a-ff33-c039-e053-2a95a90ae6c72025-12-30WarningsExact identifier
unii: B697894SGQ
Avenova Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLNovaBay Pharmaceuticals, Inc.cd17f037-5aa5-0ef8-e053-2a95a90a39cb2025-12-30WarningsExact identifier
unii: B697894SGQ
Equate Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalmart, Inc.deebaf7f-f20d-4d7f-e053-2a95a90a4b4f2025-12-30WarningsExact identifier
unii: B697894SGQ
Equate Multi-Symptom Relief Eye DropsPOLYETHYLENE GLYCOL 400,TETRAHYDROZOLINE HCL, ZINC SULFATEWalmart, Inc.eb8ed76b-9cd7-3636-e053-2a95a90a95832025-12-30WarningsExact identifier
unii: B697894SGQ
CorneaCare Recover Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCorneaCare Inc.1fd3a5ed-8963-5c8e-e063-6394a90a65272025-12-30WarningsExact identifier
unii: B697894SGQ
Quality Choice Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd1b36a-a07a-a1db-e063-6294a90a59942025-12-30WarningsExact identifier
unii: B697894SGQ
Quality Choice Moisturizing Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLChain Drug Marketing Association, Inc.1fb81759-5931-59c8-e063-6294a90a22772025-12-30WarningsExact identifier
unii: B697894SGQ

Reported adverse events (FAERS/openFDA)#

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