ninlaro

Generic: ixazomib

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ninlaro
Generic Name ixazomib
Labeler takeda pharmaceuticals america, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

ixazomib citrate 4 mg/1

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 63020-400
Product ID 63020-400_16e9f7cd-6a19-4ad1-9431-8205898a33f1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208462
Listing Expiration 2026-12-31
Marketing Start 2015-11-20

Pharmacologic Class

Classes
proteasome inhibitor [epc] proteasome inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63020400
Hyphenated Format 63020-400

Supplemental Identifiers

RxCUI
1723757 1723763 1723765 1723767 1723770 1723772
UNII
46CWK97Z3K

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ninlaro (source: ndc)
Generic Name ixazomib (source: ndc)
Application Number NDA208462 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 1 CAPSULE in 1 BLISTER PACK (63020-400-01)
  • 1 BLISTER PACK in 1 CARTON (63020-400-02) / 3 CAPSULE in 1 BLISTER PACK (63020-400-03)
source: ndc

Packages (2)

63020-400-01 1 CAPSULE in 1 BLISTER PACK (63020-400-01) 63020-400-02 1 BLISTER PACK in 1 CARTON (63020-400-02) / 3 CAPSULE in 1 BLISTER PACK (63020-400-03)

Ingredients (1)

ixazomib citrate (4 mg/1)

Linked Drug Pages (1)

NINLARO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "16e9f7cd-6a19-4ad1-9431-8205898a33f1", "openfda": {"unii": ["46CWK97Z3K"], "rxcui": ["1723757", "1723763", "1723765", "1723767", "1723770", "1723772"], "spl_set_id": ["038f2461-834b-4488-9ebd-863c83eef5a7"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CAPSULE in 1 BLISTER PACK (63020-400-01)", "package_ndc": "63020-400-01", "marketing_start_date": "20151120"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (63020-400-02)  / 3 CAPSULE in 1 BLISTER PACK (63020-400-03)", "package_ndc": "63020-400-02", "marketing_start_date": "20151120"}], "brand_name": "NINLARO", "product_id": "63020-400_16e9f7cd-6a19-4ad1-9431-8205898a33f1", "dosage_form": "CAPSULE", "pharm_class": ["Proteasome Inhibitor [EPC]", "Proteasome Inhibitors [MoA]"], "product_ndc": "63020-400", "generic_name": "ixazomib", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NINLARO", "active_ingredients": [{"name": "IXAZOMIB CITRATE", "strength": "4 mg/1"}], "application_number": "NDA208462", "marketing_category": "NDA", "marketing_start_date": "20151120", "listing_expiration_date": "20261231"}