NDC 76189-113

Alunbrig

Brigatinib

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

• Product ID: 76189-113_76928450-348f-4d49-b086-17866cfb34c6
• NDC: 76189-113
• Product Type: Human Prescription Drug
• Proprietary Name: Alunbrig
• Generic Name: Brigatinib
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-04-28
• Marketing End Date: 2020-12-12
• Marketing Category: NDA / NDA
• Application Number: NDA208772
• Labeler Name: ARIAD Pharmaceuticals Inc.
• Substance Name: BRIGATINIB
• Active Ingredient Strength: 30 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Tyrosine Kinase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA]
• NDC Exclude Flag: N

Packaging

NDC 76189-113-18

180 TABLET, COATED in 1 BOTTLE (76189-113-18)

• Marketing Start Date: 2017-04-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 76189-113-18 [76189011318]

Alunbrig TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA208772
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-04-28
• Marketing End Date: 2020-12-12

NDC 76189-113-21 [76189011321]

Alunbrig TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA208772
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-04-28
• Marketing End Date: 2020-12-12

Drug Details

Active Ingredients

Ingredient	Strength
BRIGATINIB	30 mg/1

OpenFDA Data

• SPL SET ID: 07b71b73-1ca3-4e78-a787-e458917f1f23
• Manufacturer:
  • ARIAD Pharmaceuticals Inc.
• UNII:
  • HYW8DB273J
• RxNorm Concept Unique ID - RxCUI:
  • 1921228
  • 1921222

Pharmacological Class

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