NDC 63020-180

Alunbrig

Brigatinib

Alunbrig is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Brigatinib.

• Product ID: 63020-180_016a4a8c-c47c-49a2-b38f-439eebc4c466
• NDC: 63020-180
• Product Type: Human Prescription Drug
• Proprietary Name: Alunbrig
• Generic Name: Brigatinib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-04-28
• Marketing Category: NDA / NDA
• Application Number: NDA208772
• Labeler Name: Takeda Pharmaceuticals America, Inc.
• Substance Name: BRIGATINIB
• Active Ingredient Strength: 180 mg/1
• Pharm Classes: Cytochrome P450 3A Inducers [MoA], Kinase Inhibitor [EPC], Tyrosine Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 63020-180-30

30 TABLET, FILM COATED in 1 BOTTLE (63020-180-30)

• Marketing Start Date: 2017-10-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63020-180-30 [63020018030]

Alunbrig TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA208772
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-10-02

Drug Details

Active Ingredients

Ingredient	Strength
BRIGATINIB	180 mg/1

OpenFDA Data

• SPL SET ID: 0fe9ff20-d402-41f3-bc1e-7002ea7007db
• Manufacturer:
  • Millennium Pharmaceuticals, Inc.
• UNII:
  • HYW8DB273J
• RxNorm Concept Unique ID - RxCUI:
  • 1921228
  • 1988786
  • 1921222
  • 1988772
  • 1988770
  • 1925494
  • 1988768
  • 1988785

Pharmacological Class

• Kinase Inhibitor [EPC]
• Tyrosine Kinase Inhibitors [MoA]
• Cytochrome P450 3A Inducers [MoA]

NDC Crossover Matching brand name "Alunbrig" or generic name "Brigatinib"

NDC	Brand Name	Generic Name
63020-090	Alunbrig	brigatinib
63020-113	Alunbrig	brigatinib
63020-180	Alunbrig	brigatinib
63020-198	Alunbrig	brigatinib
76189-113	Alunbrig	Brigatinib