NDC 63759-3032-01 - 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
63759-3032
Requested NDC
63759-3032-01
Package NDCs from labels
63759-3032-1, 63759-3032-01
Manufacturer
Shilpa Medicare Limited | Amneal Oncology Private Limited
Effective date
2024-08-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bortezomib - Shilpa Medicare Limited | Amneal Oncology Private LimitedShilpa Medicare Limited | Amneal Oncology Private Limited2024-08-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63759-3032-1Bortezomib1 in 1 CARTONINJECTION11
63759-3032-1Bortezomib1.4 mL in 1 VIAL, SINGLE-DOSEINJECTION1.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63759-3032BORTEZOMIB INJECTION [SHILPA MEDICARE LIMITED]1Current NDC, 2 package rows20240926_61539d49-dc21-4576-8813-4bc8abf3868c.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 2 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BortezomibBORTEZOMIBSintetica US LLCd79a71ec-b46d-4961-ad05-8980915cba942023-10-09Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
BORTEZOMIBBORTEZOMIBHospira, Inc.9fdf6169-699f-40eb-bda1-760253062b3c2023-02-27Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
BortezomibBORTEZOMIBNovadoz Pharmaceuticals LLCd41340c2-7fe8-42b2-aaa5-c9f9b0e9b50e2022-07-20Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
BortezomibBORTEZOMIBBluePoint Laboratories12500f21-8e2f-4bcd-861e-4dfca843da2e2022-05-16Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
BortezomibBORTEZOMIBQilu Pharmaceutical Co., Ltd.aef02171-bf8a-43ad-b40c-7642623f98022022-05-09Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
BORTEZOMIBBORTEZOMIBZydus Lifesciences Limited582c7c0d-fa25-4586-8157-a1e2653d72d92022-05-05Exact identifier
unii: 69G8BD63PP
BortezomibBORTEZOMIBPharmascience Inc.191d231a-1fbd-4a65-9d33-d5dc03bac3812022-05-02Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
BortezomibBORTEZOMIBWaverley Pharma Inca73d7ea7-d068-4d25-b368-fc3db1898be22022-04-13Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
bortezomibBORTEZOMIBHikma Pharmaceuticals USA Inc.854be921-5fd9-482a-8432-a0c0241625f82021-11-22Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
BortezomibBORTEZOMIBMAIA Pharmaceuticals, Inc.c40e6a28-d577-43d4-bca6-bef28da1d5802021-09-22Warnings, Adverse reactionsExact identifier
rxcui: 2608948
unii: 69G8BD63PP

Reported adverse events (FAERS/openFDA)#

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