FDA.reportPublic FDA data

NDC 60505-6050-04 - BORTEZOMIB

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
60505-6050
Requested NDC
60505-6050-04
Package NDCs from labels
60505-6050-4, 60505-6050-04
Manufacturer
Apotex Corp | Apotex Inc
Effective date
2026-09-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BORTEZOMIB - Apotex Corp | Apotex IncApotex Corp | Apotex Inc2026-09-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-6050-4BORTEZOMIB1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,16
60505-6050-4BORTEZOMIB1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6050BORTEZOMIB (BORTEZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APOTEX CORP ]5Current NDC, Legacy NDC, 2 package rows20241018_b605b541-4bfd-db3e-9710-11c27f6dee6c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6050-4EA - Each60505-6050c31f4543-be31-42a6-98df-045f390615e412022-06-06

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 1 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BORTEZOMIBBORTEZOMIBApotex Corpb605b541-4bfd-db3e-9710-11c27f6dee6c2026-09-09Warnings, Adverse reactionsExact identifier
application number: ANDA205533
ndc (package): 60505-6050-4
ndc (product): 60505-6050
ndc11 (package): 60505605004
rxcui: 402243
spl id: 4c9c541b-523c-6dd8-284a-d66f44d8f7e7
spl set id: b605b541-4bfd-db3e-9710-11c27f6dee6c
unii: 69G8BD63PP
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
BortezomibBORTEZOMIBAvenacy, LLCdecb5d94-2ea2-48d8-b08b-3196b24c0ed32026-01-09Warnings, Adverse reactionsExact identifier
rxcui: 402243
unii: 69G8BD63PP
BortezomibBORTEZOMIBGland Pharma Limitedcd698074-da21-4b53-8f6b-241535a8d5982026-01-08Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
BortezomibBORTEZOMIBNingbo Shuangcheng Pharmaceutical Co., Ltd.b17ca681-59a5-4af7-98a4-953b383798932025-12-30Warnings, Adverse reactionsExact identifier
rxcui: 402243
unii: 69G8BD63PP
BORTEZOMIBBORTEZOMIBEugia US LLCed526447-a4fe-403b-8f08-21ce1b2fa8b72025-12-23Warnings, Adverse reactionsExact identifier
rxcui: 402243
unii: 69G8BD63PP
BortezomibBORTEZOMIBBluePoint Laboratories10f60367-0476-4acd-861b-90c18d4b81642025-11-20Warnings, Adverse reactionsExact identifier
rxcui: 402243
unii: 69G8BD63PP
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
VELCADEBORTEZOMIBTakeda Pharmaceuticals America, Inc.1521d321-e724-4ffc-adad-34bf4f44fac72025-08-28Warnings, Adverse reactionsExact identifier
rxcui: 402243
unii: 69G8BD63PP
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
BortezomibBORTEZOMIBBluePoint Laboratoriesc6b620c6-f3d6-4ff3-b46a-50a66e6d41dd2025-07-31Warnings, Adverse reactionsExact identifier
rxcui: 402243
unii: 69G8BD63PP
BortezomibBORTEZOMIBMeitheal Pharmaceuticals Inc.322e315f-dd94-475f-94f4-4d86a7eb55902025-07-23Warnings, Adverse reactionsExact identifier
rxcui: 402243
unii: 69G8BD63PP
BORUZUBORTEZOMIBAmneal Pharmaceuticals LLCb92628dd-fa09-4c3a-b6a3-66426025807c2025-07-05Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
BortezomibBORTEZOMIBSomerset Therapeutics LLCdc737d3d-2a4e-448a-ad70-e013065c411c2025-05-10Warnings, Adverse reactionsExact identifier
rxcui: 402243
unii: 69G8BD63PP
BortezomibBORTEZOMIBNorthStar RxLLC3f02670b-5683-780c-9d38-5d8f0ef43a142025-05-06Warnings, Adverse reactionsExact identifier
rxcui: 402243
unii: 69G8BD63PP

Reported adverse events (FAERS/openFDA)#

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