NDC 57962-280

Imbruvica

Ibrutinib

Imbruvica is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pharmacyclics Llc. The primary component is Ibrutinib.

• Product ID: 57962-280_0d02fa60-b63e-4a9d-9db2-0138cd052b33
• NDC: 57962-280
• Product Type: Human Prescription Drug
• Proprietary Name: Imbruvica
• Generic Name: Ibrutinib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-02-16
• Marketing Category: NDA / NDA
• Application Number: NDA210563
• Labeler Name: Pharmacyclics LLC
• Substance Name: IBRUTINIB
• Active Ingredient Strength: 280 mg/1
• Pharm Classes: Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 57962-280-28

1 BLISTER PACK in 1 CARTON (57962-280-28) > 28 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2018-02-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57962-280-28 [57962028028]

Imbruvica TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA210563
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-02-16

Drug Details

Active Ingredients

Ingredient	Strength
IBRUTINIB	280 mg/1

OpenFDA Data

• SPL SET ID: 0dfd0279-ff17-4ea9-89be-9803c71bab44
• Manufacturer:
  • Pharmacyclics LLC
• UNII:
  • 1X70OSD4VX
• RxNorm Concept Unique ID - RxCUI:
  • 1442992
  • 1442986
  • 2000017
  • 1994362
  • 2000019
  • 2000029
  • 2000023
  • 2000031
  • 2000021
  • 2000027
  • 2000025
  • 1994360

Pharmacological Class

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

NDC Crossover Matching brand name "Imbruvica" or generic name "Ibrutinib"

NDC	Brand Name	Generic Name
57962-007	Imbruvica	Ibrutinib
57962-014	Imbruvica	Ibrutinib
57962-070	Imbruvica	Ibrutinib
57962-140	Imbruvica	Ibrutinib
57962-280	Imbruvica	Imbruvica
57962-420	Imbruvica	Imbruvica
57962-560	Imbruvica	Imbruvica