FDA.reportPublic FDA data

NDC 63020-390-03 - NINLARO

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
63020-390
Requested NDC
63020-390-03
Package NDCs from labels
63020-390-03, 63020-390-02, 63020-390-01
Manufacturer
Takeda Pharmaceuticals America, Inc. | Eurofins Lancaster Laboratories, Inc | AndersonBrecon (UK) Limited | Eurofins Biopharma Product Testing Ireland Limited | Almac Sciences Limited
Effective date
2026-08-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NINLAROTakeda Pharmaceuticals America, Inc. | Eurofins Lancaster Laboratories, Inc | AndersonBrecon (UK) Limited | Eurofins Biopharma Product Testing Ireland Limited | Almac Sciences Limited2026-08-11HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63020-390-012025-08-18These highlights do not include all the information needed to use NINLARO safely and effectively. See full prescribing information for NINLARO. NINLARO ® (ixazomib) capsules, for oral use Initial U.S. Approval: 2015
63020-390-012025-08-18These highlights do not include all the information needed to use NINLARO ® safely and effectively. See full prescribing information for NINLARO. NINLARO (ixazomib) capsules, for oral use Initial U.S. Approval: 2015
63020-390-022025-08-18These highlights do not include all the information needed to use NINLARO safely and effectively. See full prescribing information for NINLARO. NINLARO ® (ixazomib) capsules, for oral use Initial U.S. Approval: 2015
63020-390-022025-08-18These highlights do not include all the information needed to use NINLARO ® safely and effectively. See full prescribing information for NINLARO. NINLARO (ixazomib) capsules, for oral use Initial U.S. Approval: 2015
63020-390-012025-07-29These highlights do not include all the information needed to use NINLARO safely and effectively. See full prescribing information for NINLARO. NINLARO ® (ixazomib) capsules, for oral use Initial U.S. Approval: 2015
63020-390-012025-07-29These highlights do not include all the information needed to use NINLARO ® safely and effectively. See full prescribing information for NINLARO. NINLARO (ixazomib) capsules, for oral use Initial U.S. Approval: 2015
63020-390-022025-07-29These highlights do not include all the information needed to use NINLARO safely and effectively. See full prescribing information for NINLARO. NINLARO ® (ixazomib) capsules, for oral use Initial U.S. Approval: 2015
63020-390-022025-07-29These highlights do not include all the information needed to use NINLARO ® safely and effectively. See full prescribing information for NINLARO. NINLARO (ixazomib) capsules, for oral use Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63020-390-01NINLARO1 in 1 BLISTER PACKCAPSULE116
63020-390-02NINLARO1 in 1 CARTONCAPSULE116
63020-390-03NINLARO3 in 1 BLISTER PACKCAPSULE316

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63020-390NINLARO (IXAZOMIB) CAPSULE [TAKEDA PHARMACEUTICALS AMERICA, INC.]14Current NDC, Legacy NDC, 3 package rows20240911_038f2461-834b-4488-9ebd-863c83eef5a7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63020-390-01EA - Each63020-39086a47240-ad9c-43e0-a265-2fc381e2b9b412021-01-08
63020-390-02EA - Each63020-390f17d53ec-6c5c-4f8d-ba2b-6323e66eabfb12021-01-08
63020-390-03EA - Each63020-3906a7c91ed-e10b-464a-9a89-985c098b828112025-02-10

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NINLAROIXAZOMIBTakeda Pharmaceuticals America, Inc.038f2461-834b-4488-9ebd-863c83eef5a72026-08-11Warnings, Adverse reactionsExact identifier
application number: NDA208462
ndc (package): 63020-390-02
ndc (package): 63020-400-03
ndc (package): 63020-400-02
ndc (package): 63020-400-01
ndc (package): 63020-230-02
ndc (package): 63020-390-03
ndc (package): 63020-230-03
ndc (package): 63020-230-01
ndc (package): 63020-390-01
ndc (product): 63020-400
ndc (product): 63020-390
ndc (product): 63020-230
ndc11 (package): 63020039003
rxcui: 1723757
rxcui: 1723767
rxcui: 1723765
rxcui: 1723770
rxcui: 1723763
rxcui: 1723772
spl id: 184bc16b-40f1-4fd3-a70b-17bbb44eac21
spl set id: 038f2461-834b-4488-9ebd-863c83eef5a7
unii: 46CWK97Z3K
Steritalc 2gTALCNovatech SAc94e51d9-beef-4b06-e053-2a95a90a754a2025-06-25Warnings, Adverse reactionsExact identifier
unii: 7SEV7J4R1U
SENSITIVE POCKET SUNSENSITIVE POCKET SUNShantou Oushiya Biotechnology Co., Ltd36ac412f-e31f-6906-e063-6394a90a4a3d2025-06-14WarningsExact identifier
unii: 7SEV7J4R1U
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U

Reported adverse events (FAERS/openFDA)#

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