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 1 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BORTEZOMIBBORTEZOMIBApotex Corpb605b541-4bfd-db3e-9710-11c27f6dee6c2026-09-09Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
BortezomibBORTEZOMIBAvenacy, LLCdecb5d94-2ea2-48d8-b08b-3196b24c0ed32026-01-09Warnings, Adverse reactionsExact identifier
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
unii: 69G8BD63PP
BORTEZOMIBBORTEZOMIBEugia US LLCed526447-a4fe-403b-8f08-21ce1b2fa8b72025-12-23Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
BortezomibBORTEZOMIBBluePoint Laboratories10f60367-0476-4acd-861b-90c18d4b81642025-11-20Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
VELCADEBORTEZOMIBTakeda Pharmaceuticals America, Inc.1521d321-e724-4ffc-adad-34bf4f44fac72025-08-28Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
BortezomibBORTEZOMIBBluePoint Laboratoriesc6b620c6-f3d6-4ff3-b46a-50a66e6d41dd2025-07-31Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
BortezomibBORTEZOMIBMeitheal Pharmaceuticals Inc.322e315f-dd94-475f-94f4-4d86a7eb55902025-07-23Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
BORUZUBORTEZOMIBAmneal Pharmaceuticals LLCb92628dd-fa09-4c3a-b6a3-66426025807c2025-07-05Warnings, Adverse reactionsExact identifier
application number: NDA212782
rxcui: 2608948
unii: 69G8BD63PP
BortezomibBORTEZOMIBSomerset Therapeutics LLCdc737d3d-2a4e-448a-ad70-e013065c411c2025-05-10Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
BortezomibBORTEZOMIBNorthStar RxLLC3f02670b-5683-780c-9d38-5d8f0ef43a142025-05-06Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
BORTEZOMIBBORTEZOMIBSagent Pharmaceuticals945fbaf0-7a79-4676-aa90-e9a213c0654f2025-05-05Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
BortezomibBORTEZOMIBFresenius Kabi USA, LLC3494c357-a692-4e55-89e1-93532b0baef72025-03-27Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
BORTEZOMIBBORTEZOMIBZydus Pharmaceuticals USA Inc.0eb8daef-18da-43bb-b7c6-38c4c8b5dd802024-12-05Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
BortezomibBORTEZOMIBShilpa Medicare Limited61539d49-dc21-4576-8813-4bc8abf3868c2024-08-30Warnings, Adverse reactionsExact identifier
application number: NDA212782
ndc (package): 63759-3032-1
ndc (product): 63759-3032
ndc11 (package): 63759303201
rxcui: 2608948
spl id: 71ebcbb5-31e2-4394-8a38-d833fd3c733a
spl set id: 61539d49-dc21-4576-8813-4bc8abf3868c
unii: 69G8BD63PP
BortezomibBORTEZOMIBCamber Pharmaceuticals, Inc.04aafa6a-a50d-4a47-a831-be8e8bb992ac2024-07-22Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
BortezomibBORTEZOMIBDr.Reddy's Laboratories, Inc.664bee24-7af2-2099-ac99-5dd71a1e5a142024-05-17Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
BortezomibBORTEZOMIBHospira, Inc.41e3de39-8278-4a75-badf-601e4602080d2024-04-09Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
BORTEZOMIBBORTEZOMIBEugia US LLC76c7c3a5-fd2f-403f-85fd-65a64538eee72023-10-20Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP

Reported adverse events (FAERS/openFDA)#

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