FDA.reportPublic FDA data

NDC 60505-6177-0 - 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
60505-6177
Requested NDC
60505-6177-0
Package NDCs from labels
60505-6177-0, 60505-6177-8
Manufacturer
Apotex Corp.
Effective date
2022-01-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Busulfan - Apotex Corp.Apotex Corp.2022-01-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6177-0ML - Milliliter60505-617774541e2e-d6af-431f-b0ba-61f481b457d612019-09-05
60505-6177-8ML - Milliliter60505-617719950694-cfe4-4fbf-b960-e3e90b2a187812019-09-05

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 1 of 1 ยท 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BusulfanBUSULFANSagent Pharmaceuticals086a715e-4958-4bb5-9ebd-86171e6b62032026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G1LN9045DK
MYLERANBUSULFANWaylis Therapeutics LLC2da33e5b-dcfb-4cdf-b163-50398e42f41c2025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G1LN9045DK
BusulfanBUSULFANEugia US LLC06883ac0-4b2a-4f26-89bf-512d37b9ba7f2024-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G1LN9045DK
BusulfanBUSULFANAccord Healthcare, Incfe0ddd44-ef02-4827-b164-7fcbb45bcc1b2024-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G1LN9045DK
BusulfanBUSULFANPharmascience Inc.d0fe44f9-7747-4909-b927-3b24aa6e7e092022-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G1LN9045DK
a0b0bc32-8fc8-8c09-04bf-6a751c60360ea67d61d4-f985-e653-5343-b49d17784b3c2022-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: a0b0bc32-8fc8-8c09-04bf-6a751c60360e
spl set id: a67d61d4-f985-e653-5343-b49d17784b3c
BUSULFANBUSULFANHospira, Inc.b9c7f0dc-988d-466e-8031-400ec4f60f212021-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G1LN9045DK
BusulfanBUSULFANMeitheal Pharmaceuticals Inc.dc384f16-4e25-458e-874c-553f81c6d8c92021-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G1LN9045DK
BusulfanBUSULFANMeitheal Pharmaceuticals Inc.6e68ab21-19bd-4b7e-b8d0-bf284d5af1832021-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G1LN9045DK
BusulfanBUSULFANAmneal Pharmaceuticals LLCac9448da-37ad-4609-9aef-eedf8be0f69c2020-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G1LN9045DK

Reported adverse events (FAERS/openFDA)#

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