NDC 69853-0201

BEVYXXA

Betrixaban

BEVYXXA is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Portola Pharmaceuticals, Inc.. The primary component is Betrixaban.

• Product ID: 69853-0201_2e844c6c-8a74-441c-bb92-30c34b0dce08
• NDC: 69853-0201
• Product Type: Human Prescription Drug
• Proprietary Name: BEVYXXA
• Generic Name: Betrixaban
• Dosage Form: Capsule, Gelatin Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-07-07
• Marketing Category: NDA / NDA
• Application Number: NDA208383
• Labeler Name: Portola Pharmaceuticals, Inc.
• Substance Name: BETRIXABAN
• Active Ingredient Strength: 80 mg/1
• Pharm Classes: Factor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69853-0201-1

1 BOTTLE in 1 CARTON (69853-0201-1) > 100 CAPSULE, GELATIN COATED in 1 BOTTLE

• Marketing Start Date: 2017-07-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69853-0201-1 [69853020101]

BEVYXXA CAPSULE, GELATIN COATED

• Marketing Category: NDA
• Application Number: NDA208383
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-07-07

Drug Details

Active Ingredients

Ingredient	Strength
BETRIXABAN	80 mg/1

OpenFDA Data

• SPL SET ID: ebaa2dd9-257e-4a68-ab6a-fb2791bb62ce
• Manufacturer:
  • Portola Pharmaceuticals, Inc.
• UNII:
  • 74RWP7W0J9
• RxNorm Concept Unique ID - RxCUI:
  • 1927862
  • 1927856
  • 1927864
  • 1927866
• UPC Code:
  • 0369853020215
  • 0369853020116

Pharmacological Class

• Factor Xa Inhibitors [MoA]
• Factor Xa Inhibitor [EPC]

NDC Crossover Matching brand name "BEVYXXA" or generic name "Betrixaban"

NDC	Brand Name	Generic Name
69853-0201	BEVYXXA	betrixaban
69853-0202	BEVYXXA	betrixaban