FDA.reportPublic FDA data

NDC 55150-395-01 - Busulfan

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
55150-395
Requested NDC
55150-395-01
Package NDCs from labels
55150-395-01, 55150-395-08
Manufacturer
Eugia US LLC | EUGIA Pharma Specialities Limited
Effective date
2024-06-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Busulfan - Eugia US LLC | EUGIA Pharma Specialities LimitedEugia US LLC | EUGIA Pharma Specialities Limited2024-06-27Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-395-01Busulfan10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION101
55150-395-08Busulfan8 in 1 CARTONINJECTION, SOLUTION81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-395BUSULFAN INJECTION, SOLUTION [EUGIA US LLC]1Current NDC, 2 package rows20240628_06883ac0-4b2a-4f26-89bf-512d37b9ba7f.zip

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 · 130 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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.