NDC 71332-001

TAVALISSE

Fostamatinib

TAVALISSE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Rigel Pharmaceuticals, Inc.. The primary component is Fostamatinib.

• Product ID: 71332-001_0ee88fed-f00f-4c05-9d26-579399ef38f4
• NDC: 71332-001
• Product Type: Human Prescription Drug
• Proprietary Name: TAVALISSE
• Generic Name: Fostamatinib
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-05-09
• Marketing Category: NDA / NDA
• Application Number: NDA209299
• Labeler Name: Rigel Pharmaceuticals, Inc.
• Substance Name: FOSTAMATINIB
• Active Ingredient Strength: 100 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 71332-001-01

60 TABLET in 1 BOTTLE (71332-001-01)

• Marketing Start Date: 2018-05-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71332-001-01 [71332000101]

TAVALISSE TABLET

• Marketing Category: NDA
• Application Number: NDA209299
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-05-09
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-05-05

Drug Details

Active Ingredients

Ingredient	Strength
FOSTAMATINIB	100 mg/1

OpenFDA Data

• SPL SET ID: 21149cc3-049b-43e2-b141-c9499160556c
• Manufacturer:
  • Rigel Pharmaceuticals, Inc.
• UNII:
  • SQ8A3S5101
• RxNorm Concept Unique ID - RxCUI:
  • 2044930
  • 2044932
  • 2044922
  • 2044928
• UPC Code:
  • 0371332001011

NDC Crossover Matching brand name "TAVALISSE" or generic name "Fostamatinib"

NDC	Brand Name	Generic Name
71332-001	TAVALISSE	FOSTAMATINIB
71332-002	TAVALISSE	FOSTAMATINIB