NDC 57962-007

Imbruvica

Ibrutinib

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

• Product ID: 57962-007_0d02fa60-b63e-4a9d-9db2-0138cd052b33
• NDC: 57962-007
• Product Type: Human Prescription Drug
• Proprietary Name: Imbruvica
• Generic Name: Ibrutinib
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2022-08-24
• Marketing Category: NDA /
• Application Number: NDA217003
• Labeler Name: Pharmacyclics LLC
• Substance Name: IBRUTINIB
• Active Ingredient Strength: 70 mg/mL
• Pharm Classes: Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 57962-007-12

1 BOTTLE, GLASS in 1 CARTON (57962-007-12) > 108 mL in 1 BOTTLE, GLASS

• Marketing Start Date: 2022-08-24
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

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