NDC 71334-100

Tibsovo

Ivosidenib

Tibsovo is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Agios Pharmaceuticals, Inc.. The primary component is Ivosidenib.

• Product ID: 71334-100_05b9d296-44dd-4ee6-9702-84d3b2c263d6
• NDC: 71334-100
• Product Type: Human Prescription Drug
• Proprietary Name: Tibsovo
• Generic Name: Ivosidenib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-07-20
• Marketing Category: NDA / NDA
• Application Number: NDA211192
• Labeler Name: Agios Pharmaceuticals, Inc.
• Substance Name: IVOSIDENIB
• Active Ingredient Strength: 250 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 71334-100-01

60 TABLET, FILM COATED in 1 BOTTLE (71334-100-01)

• Marketing Start Date: 2018-07-20
• Marketing End Date: 2024-11-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71334-100-01 [71334010001]

Tibsovo TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA211192
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-07-20

Drug Details

Active Ingredients

Ingredient	Strength
IVOSIDENIB	250 mg/1

OpenFDA Data

• SPL SET ID: 5b6d8ae8-bac8-4e1b-b1b4-7f9665e62de5
• Manufacturer:
  • Agios Pharmaceuticals, Inc.
• UNII:
  • Q2PCN8MAM6
• RxNorm Concept Unique ID - RxCUI:
  • 2049884
  • 2049878
• UPC Code:
  • 0371334100026
  • 0371334100019

NDC Crossover Matching brand name "Tibsovo" or generic name "Ivosidenib"

NDC	Brand Name	Generic Name
71334-100	Tibsovo	ivosidenib
72694-617	TIBSOVO	ivosidenib