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 7 of 7 · 132 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SystanePOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLAlcon Research Ltd14916d2c-a63d-491e-bd91-a61f300af38a2023-12-15WarningsExact identifier
unii: B697894SGQ
Systane LubricantPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.15bc06ec-f3dc-3180-ca1a-106769a770ea2023-12-15WarningsExact identifier
unii: B697894SGQ
Systane ULTRAPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.a5c1c194-3db5-4f18-9cd1-97f7f84c3cff2023-12-15WarningsExact identifier
unii: B697894SGQ
GenTeal Tears Gel DropsPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.84388a75-9d11-48ce-bf5a-88f0580d2d032023-12-14WarningsExact identifier
unii: B697894SGQ
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: B697894SGQ
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
unii: B697894SGQ
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
unii: B697894SGQ
BusulfanBUSULFANPharmascience Inc.d0fe44f9-7747-4909-b927-3b24aa6e7e092022-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 253113
unii: G1LN9045DK
BUSULFANBUSULFANHospira, Inc.b9c7f0dc-988d-466e-8031-400ec4f60f212021-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 253113
unii: G1LN9045DK
BusulfanBUSULFANMeitheal Pharmaceuticals Inc.dc384f16-4e25-458e-874c-553f81c6d8c92021-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 253113
unii: G1LN9045DK
BusulfanBUSULFANMeitheal Pharmaceuticals Inc.6e68ab21-19bd-4b7e-b8d0-bf284d5af1832021-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 253113
unii: G1LN9045DK
BusulfanBUSULFANAmneal Pharmaceuticals LLCac9448da-37ad-4609-9aef-eedf8be0f69c2020-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 253113
unii: G1LN9045DK

Reported adverse events (FAERS/openFDA)#

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