FDA.reportPublic FDA data

NINLARO

Product NDC
63020-230
11-digit product format
630200230
Labeler code
63020
Product ID
63020-230_16e9f7cd-6a19-4ad1-9431-8205898a33f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ixazomib
Dosage form
CAPSULE
Route
ORAL
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA208462
Marketing category
NDA
Marketing start
2015-11-20
Substance
IXAZOMIB CITRATE
Active strength
2.3 mg/1
Pharmacologic classes
Proteasome Inhibitor [EPC], Proteasome Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NINLARO
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IXAZOMIB CITRATE2.3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii46CWK97Z3K
Rxcui1723757, 1723763, 1723765, 1723767, 1723770, 1723772

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
e65a2211-20c4-4e19-9563-61fcdff0377dProduct name120151215

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63020-230-012025-08-18C16284748780-13b156c62-26f7-fb37-e063-e6dba90a4e07These 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
63020-230-022025-08-18C16284748780-13b156c62-26f7-fb37-e063-e6dba90a4e07These 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
63020-230-012025-07-29C16284748780-13b156c62-26f7-fb37-e063-e6dba90a4e07These 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
63020-230-022025-07-29C16284748780-13b156c62-26f7-fb37-e063-e6dba90a4e07These 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
63020-230-01NINLARO1 in 1 BLISTER PACKCAPSULE116
63020-230-02NINLARO1 in 1 CARTONCAPSULE116
63020-230-03NINLARO3 in 1 BLISTER PACKCAPSULE316

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63020-230-01EA - Each63020-230603e9b13-b34c-4685-8f6a-01988c2a013412021-01-08
63020-230-02EA - Each63020-23050638c2f-72eb-47ca-a202-462c0dc10b2d12021-01-08
63020-230-03EA - Each63020-23013a3e51a-8952-4799-a1b7-79558ea9d4c512024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63020-230NINLARO (IXAZOMIB) CAPSULE [TAKEDA PHARMACEUTICALS AMERICA, INC.]14Current NDC, Legacy NDC, 3 package rows20240911_038f2461-834b-4488-9ebd-863c83eef5a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723757ixazomib 2.3 MG Oral CapsulePSN038f2461-834b-4488-9ebd-863c83eef5a716
1723765ixazomib 3 MG Oral CapsulePSN038f2461-834b-4488-9ebd-863c83eef5a716
1723770ixazomib 4 MG Oral CapsulePSN038f2461-834b-4488-9ebd-863c83eef5a716
1723763NINLARO 2.3 MG Oral CapsulePSN038f2461-834b-4488-9ebd-863c83eef5a716
1723767NINLARO 3 MG Oral CapsulePSN038f2461-834b-4488-9ebd-863c83eef5a716
1723772NINLARO 4 MG Oral CapsulePSN038f2461-834b-4488-9ebd-863c83eef5a716
1723763ixazomib 2.3 MG Oral Capsule [Ninlaro]SBD038f2461-834b-4488-9ebd-863c83eef5a716
1723767ixazomib 3 MG Oral Capsule [Ninlaro]SBD038f2461-834b-4488-9ebd-863c83eef5a716
1723772ixazomib 4 MG Oral Capsule [Ninlaro]SBD038f2461-834b-4488-9ebd-863c83eef5a716
1723757ixazomib 2.3 MG Oral CapsuleSCD038f2461-834b-4488-9ebd-863c83eef5a716
1723765ixazomib 3 MG Oral CapsuleSCD038f2461-834b-4488-9ebd-863c83eef5a716
1723770ixazomib 4 MG Oral CapsuleSCD038f2461-834b-4488-9ebd-863c83eef5a716
1723757ixazomib 2.3 MG (as ixazomib citrate 3.3 MG) Oral CapsuleSY038f2461-834b-4488-9ebd-863c83eef5a716
1723765ixazomib 3 MG (as ixazomib 4.3 MG) Oral CapsuleSY038f2461-834b-4488-9ebd-863c83eef5a716
1723770ixazomib 4 MG (as ixazomib citrate 5.7 MG) Oral CapsuleSY038f2461-834b-4488-9ebd-863c83eef5a716
1723763Ninlaro 2.3 MG (as ixazomib citrate 3.3 MG) Oral CapsuleSY038f2461-834b-4488-9ebd-863c83eef5a716
1723763Ninlaro 2.3 MG Oral CapsuleSY038f2461-834b-4488-9ebd-863c83eef5a716
1723767Ninlaro 3 MG (as ixazomib citrate 4.3 MG) Oral CapsuleSY038f2461-834b-4488-9ebd-863c83eef5a716
1723767Ninlaro 3 MG Oral CapsuleSY038f2461-834b-4488-9ebd-863c83eef5a716
1723772Ninlaro 4 MG (as ixazomib citrate 5.7 MG) Oral CapsuleSY038f2461-834b-4488-9ebd-863c83eef5a716
1723772Ninlaro 4 MG Oral CapsuleSY038f2461-834b-4488-9ebd-863c83eef5a716

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63020-230-01630200230011 CAPSULE in 1 BLISTER PACK (63020-230-01) 1 capsule2015-11-20NoNoHistorical
63020-230-02630200230021 BLISTER PACK in 1 CARTON (63020-230-02) / 3 CAPSULE in 1 BLISTER PACK (63020-230-03) 1 blister pack2015-11-200000-00-00NoNoCurrent
63020-230-03630200230033 in 1 BLISTER PACKHistorical