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 4 of 7 · 132 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Lubricant Eye Drops Long LastingPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd91c45-88a2-f88c-e063-6294a90ad1272025-12-30WarningsExact identifier
unii: B697894SGQ
Archies Dry Eye ReliefPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLArchie's Remedies07da099b-6b7f-984d-e063-6294a90a12ac2025-12-30WarningsExact identifier
unii: B697894SGQ
Equaline Multi-Symptom Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEUnited Natural Foods, Inc.fe467606-6d66-b695-e053-6294a90aab5d2025-12-30WarningsExact identifier
unii: B697894SGQ
Walgreens LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4538-2061-e063-6394a90a6e732025-12-19WarningsExact identifier
unii: B697894SGQ
Artificial TearsGLYCERINGeri-Care Pharmaceuticals, Corp7cc437e3-bad9-59be-e053-2991aa0a1da32025-12-19WarningsExact identifier
unii: B697894SGQ
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: B697894SGQ
b281d2c1-122c-4a27-8a27-e222359c0fb95cb9d285-1803-4a99-946a-d0b239b32df62025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: b281d2c1-122c-4a27-8a27-e222359c0fb9
spl set id: 5cb9d285-1803-4a99-946a-d0b239b32df6
Walgreens Ultra LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4533-2061-e063-6394a90a6e732025-10-17WarningsExact identifier
unii: B697894SGQ
Dry eye reliefPOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADERf8da3af5-9172-4023-be82-0fd5bd8916162025-09-12WarningsExact identifier
unii: B697894SGQ
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
unii: B697894SGQ
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
unii: B697894SGQ
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
unii: B697894SGQ
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Morning Star OTCdcd4164c-aa1e-4f07-ab2c-b439275629db2025-06-16WarningsExact identifier
unii: B697894SGQ
Code Red Eye Drops Redness ReliefPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL4 Trees, LLC0aa08018-cc2d-d947-e063-6394a90a914a2025-02-07WarningsExact identifier
unii: B697894SGQ
MYLERANBUSULFANWaylis Therapeutics LLC2da33e5b-dcfb-4cdf-b163-50398e42f41c2025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G1LN9045DK
Rite Aid Hydration Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLRite Aid Corporationecac1351-e944-21da-e053-2995a90a6d342024-12-31WarningsExact identifier
unii: B697894SGQ
Glitch Advanced Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCLMisemer Pharmaceutical, Inc03778509-3374-2168-e063-6294a90a95052024-12-23WarningsExact identifier
unii: B697894SGQ
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Kenvue Brands LLCa9a90de6-3172-4d34-984b-f4442f880e3d2024-11-13WarningsExact identifier
unii: B697894SGQ
Visine Dry Eye ReliefPOLYETHYLENE GLYCOL 400Kenvue Brands LLC2de7a41d-661d-495f-89b4-5690664a3a3d2024-11-13WarningsExact identifier
unii: B697894SGQ
Visine Dry Eye Relief Eye DropsPOLYETHYLENE GLYCOL 400Kenvue Brands LLCd9d3f000-3ce4-4ba2-a7fb-491b44eb3fa12024-11-13WarningsExact identifier
unii: B697894SGQ

Reported adverse events (FAERS/openFDA)#

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