NDC 63020-534

Iclusig

Ponatinib Hydrochloride

Iclusig is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Millennium Pharmaceuticals, Inc.. The primary component is Ponatinib Hydrochloride.

• Product ID: 63020-534_0277cb2e-ac32-4fd4-83a4-a3132984e934
• NDC: 63020-534
• Product Type: Human Prescription Drug
• Proprietary Name: Iclusig
• Generic Name: Ponatinib Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2012-12-14
• Marketing Category: NDA / NDA
• Application Number: NDA203469
• Labeler Name: Millennium Pharmaceuticals, Inc.
• Substance Name: PONATINIB HYDROCHLORIDE
• Active Ingredient Strength: 45 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 63020-534-30

30 TABLET, FILM COATED in 1 BOTTLE (63020-534-30)

• Marketing Start Date: 2012-12-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63020-534-30 [63020053430]

Iclusig TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA203469
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-12-14

Drug Details

Active Ingredients

Ingredient	Strength
PONATINIB HYDROCHLORIDE	45 mg/1

OpenFDA Data

• SPL SET ID: 16d804b6-4957-43ee-b18c-3b36ec37c5ac
• Manufacturer:
  • Millennium Pharmaceuticals, Inc.
• UNII:
  • 96R6PU3D8J
• RxNorm Concept Unique ID - RxCUI:
  • 1364352
  • 1364358
  • 1726639
  • 1364360
  • 1364362
  • 1726637

Pharmacological Class

• Kinase Inhibitor [EPC]
• Protein Kinase Inhibitors [MoA]

NDC Crossover Matching brand name "Iclusig" or generic name "Ponatinib Hydrochloride"

NDC	Brand Name	Generic Name
63020-533	Iclusig	ponatinib hydrochloride
63020-534	Iclusig	ponatinib hydrochloride
63020-535	Iclusig	ponatinib hydrochloride
63020-536	Iclusig	ponatinib hydrochloride
76189-533	Iclusig	ponatinib hydrochloride
76189-534	Iclusig	ponatinib hydrochloride
76189-535	Iclusig	ponatinib hydrochloride