FDA.reportPublic FDA data

NDC 72485-210-01 - 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
72485-210
Requested NDC
72485-210-01
Package NDCs from labels
72485-210-01, 72485-210-08
Manufacturer
Armas Pharmaceuticals Inc.
Effective date
2019-05-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Busulfan - Armas Pharmaceuticals Inc.Armas Pharmaceuticals Inc.2019-05-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72485-210-01Busulfan10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION101
72485-210-08Busulfan8 in 1 CARTONINJECTION, SOLUTION81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-210BUSULFAN (BUSULFAN ) INJECTION, SOLUTION [ARMAS PHARMACEUTICALS INC.]1Legacy NDC, 2 package rows20190607_4049d57f-342e-4233-8292-fed6b8f128ec.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-210-01ML - Milliliter72485-210f641d406-d20a-4b36-8e6f-9f7085dc1ba812019-08-06
72485-210-08ML - Milliliter72485-210c6a7feb5-7a75-4b79-9b73-cdda3bac911f12019-08-06

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.