NDC 72579-011

BRUKINSA

Zanubrutinib

BRUKINSA is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Beigene Usa, Inc.. The primary component is Zanubrutinib.

• Product ID: 72579-011_2bc28e99-48ab-438b-8960-e0d3eb127c46
• NDC: 72579-011
• Product Type: Human Prescription Drug
• Proprietary Name: BRUKINSA
• Generic Name: Zanubrutinib
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2019-11-14
• Marketing Category: NDA / NDA
• Application Number: NDA213217
• Labeler Name: BEIGENE USA, INC.
• Substance Name: ZANUBRUTINIB
• Active Ingredient Strength: 80 mg/1
• Pharm Classes: Bruton's Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 72579-011-02

1 BOTTLE, PLASTIC in 1 CARTON (72579-011-02) > 120 CAPSULE in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2019-11-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72579-011-02 [72579001102]

BRUKINSA CAPSULE, GELATIN COATED

• Marketing Category: NDA
• Application Number: NDA213217
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-11-18

NDC 72579-011-01 [72579001101]

BRUKINSA CAPSULE, GELATIN COATED

• Marketing Category: NDA
• Application Number: NDA213217
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-11-18

Drug Details

Active Ingredients

Ingredient	Strength
ZANUBRUTINIB	80 mg/1