NDC 70771-1708-01 - 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
70771-1708
Requested NDC
70771-1708-01
Package NDCs from labels
70771-1708-1, 70771-1708-01
Manufacturer
Zydus Lifesciences Limited | Zydus Hospira Oncology Private Limited
Effective date
2022-05-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BORTEZOMIB - Zydus Lifesciences Limited | Zydus Hospira Oncology Private LimitedZydus Lifesciences Limited | Zydus Hospira Oncology Private Limited2022-05-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1708-1BORTEZOMIB3.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,3.51
70771-1708-1BORTEZOMIB1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1708BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS LIFESCIENCES LIMITED]1Current NDC, Legacy NDC, 2 package rows20220505_582c7c0d-fa25-4586-8157-a1e2653d72d9.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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BORTEZOMIBBORTEZOMIBSagent Pharmaceuticals945fbaf0-7a79-4676-aa90-e9a213c0654f2025-05-05Warnings, Adverse reactionsExact identifier
rxcui: 402243
unii: 69G8BD63PP
BortezomibBORTEZOMIBFresenius Kabi USA, LLC3494c357-a692-4e55-89e1-93532b0baef72025-03-27Warnings, Adverse reactionsExact identifier
rxcui: 402243
unii: 69G8BD63PP
BORTEZOMIBBORTEZOMIBZydus Pharmaceuticals USA Inc.0eb8daef-18da-43bb-b7c6-38c4c8b5dd802024-12-05Warnings, Adverse reactionsExact identifier
application number: ANDA210204
rxcui: 402243
unii: 69G8BD63PP
BortezomibBORTEZOMIBShilpa Medicare Limited61539d49-dc21-4576-8813-4bc8abf3868c2024-08-30Warnings, Adverse reactionsExact identifier
unii: 69G8BD63PP
BortezomibBORTEZOMIBCamber Pharmaceuticals, Inc.04aafa6a-a50d-4a47-a831-be8e8bb992ac2024-07-22Warnings, Adverse reactionsExact identifier
rxcui: 402243
unii: 69G8BD63PP
BortezomibBORTEZOMIBDr.Reddy's Laboratories, Inc.664bee24-7af2-2099-ac99-5dd71a1e5a142024-05-17Warnings, Adverse reactionsExact identifier
rxcui: 402243
unii: 69G8BD63PP
BortezomibBORTEZOMIBHospira, Inc.41e3de39-8278-4a75-badf-601e4602080d2024-04-09Warnings, Adverse reactionsExact identifier
rxcui: 402243
unii: 69G8BD63PP
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
BORTEZOMIBBORTEZOMIBEugia US LLC76c7c3a5-fd2f-403f-85fd-65a64538eee72023-10-20Warnings, Adverse reactionsExact identifier
rxcui: 402243
unii: 69G8BD63PP
BortezomibBORTEZOMIBSintetica US LLCd79a71ec-b46d-4961-ad05-8980915cba942023-10-09Warnings, Adverse reactionsExact identifier
rxcui: 402243
unii: 69G8BD63PP
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
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
rxcui: 402243
unii: 69G8BD63PP
BortezomibBORTEZOMIBBluePoint Laboratories12500f21-8e2f-4bcd-861e-4dfca843da2e2022-05-16Warnings, Adverse reactionsExact identifier
rxcui: 402243
unii: 69G8BD63PP
BortezomibBORTEZOMIBQilu Pharmaceutical Co., Ltd.aef02171-bf8a-43ad-b40c-7642623f98022022-05-09Warnings, Adverse reactionsExact identifier
rxcui: 402243
unii: 69G8BD63PP
BORTEZOMIBBORTEZOMIBZydus Lifesciences Limited582c7c0d-fa25-4586-8157-a1e2653d72d92022-05-05Exact identifier
application number: ANDA210204
ndc (package): 70771-1708-1
ndc (product): 70771-1708
ndc11 (package): 70771170801
rxcui: 402243
spl id: a7ff2205-566b-4fb5-8f33-bf73377ee093
spl set id: 582c7c0d-fa25-4586-8157-a1e2653d72d9
unii: 69G8BD63PP
BortezomibBORTEZOMIBPharmascience Inc.191d231a-1fbd-4a65-9d33-d5dc03bac3812022-05-02Warnings, Adverse reactionsExact identifier
rxcui: 402243
unii: 69G8BD63PP
BortezomibBORTEZOMIBWaverley Pharma Inca73d7ea7-d068-4d25-b368-fc3db1898be22022-04-13Warnings, Adverse reactionsExact identifier
rxcui: 402243
unii: 69G8BD63PP
bortezomibBORTEZOMIBHikma Pharmaceuticals USA Inc.854be921-5fd9-482a-8432-a0c0241625f82021-11-22Warnings, Adverse reactionsExact identifier
rxcui: 402243
unii: 69G8BD63PP

Reported adverse events (FAERS/openFDA)#

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