iclusig

Generic: ponatinib hydrochloride

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

Drug Facts

Product Profile

Brand Name iclusig
Generic Name ponatinib hydrochloride
Labeler takeda pharmaceuticals america, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ponatinib hydrochloride 15 mg/1

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 63020-535
Product ID 63020-535_185604c4-00ec-4764-b6e1-cff93f663fe8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203469
Listing Expiration 2026-12-31
Marketing Start 2012-12-14

Pharmacologic Class

Classes
kinase inhibitor [epc] protein kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63020535
Hyphenated Format 63020-535

Supplemental Identifiers

RxCUI
1364352 1364358 1364360 1364362 1726637 1726639 2473040 2473042
UNII
96R6PU3D8J

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 iclusig (source: ndc)
Generic Name ponatinib hydrochloride (source: ndc)
Application Number NDA203469 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (63020-535-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (63020-535-60)
source: ndc

Packages (2)

63020-535-30 30 TABLET, FILM COATED in 1 BOTTLE (63020-535-30) 63020-535-60 60 TABLET, FILM COATED in 1 BOTTLE (63020-535-60)

Ingredients (1)

ponatinib hydrochloride (15 mg/1)

Linked Drug Pages (1)

Iclusig ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "185604c4-00ec-4764-b6e1-cff93f663fe8", "openfda": {"unii": ["96R6PU3D8J"], "rxcui": ["1364352", "1364358", "1364360", "1364362", "1726637", "1726639", "2473040", "2473042"], "spl_set_id": ["16d804b6-4957-43ee-b18c-3b36ec37c5ac"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63020-535-30)", "package_ndc": "63020-535-30", "marketing_start_date": "20121214"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63020-535-60)", "package_ndc": "63020-535-60", "marketing_start_date": "20121214"}], "brand_name": "Iclusig", "product_id": "63020-535_185604c4-00ec-4764-b6e1-cff93f663fe8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "63020-535", "generic_name": "ponatinib hydrochloride", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Iclusig", "active_ingredients": [{"name": "PONATINIB HYDROCHLORIDE", "strength": "15 mg/1"}], "application_number": "NDA203469", "marketing_category": "NDA", "marketing_start_date": "20121214", "listing_expiration_date": "20261231"}