NDC 65597-402

Turalio

Pexidartinib

Turalio is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Daiichi Sankyo Inc.. The primary component is Pexidartinib Hydrochloride.

• Product ID: 65597-402_009b4f62-39f8-4c68-be63-8ea8a536bd36
• NDC: 65597-402
• Product Type: Human Prescription Drug
• Proprietary Name: Turalio
• Generic Name: Pexidartinib
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2019-08-02
• Marketing Category: NDA / NDA
• Application Number: NDA211810
• Labeler Name: Daiichi Sankyo Inc.
• Substance Name: PEXIDARTINIB HYDROCHLORIDE
• Active Ingredient Strength: 200 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 65597-402-20

1 BOTTLE in 1 CARTON (65597-402-20) > 120 CAPSULE in 1 BOTTLE

• Marketing Start Date: 2019-08-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65597-402-28 [65597040228]

Turalio CAPSULE

• Marketing Category: NDA
• Application Number: NDA211810
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-08-02

NDC 65597-402-20 [65597040220]

Turalio CAPSULE

• Marketing Category: NDA
• Application Number: NDA211810
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-08-02

Drug Details

Active Ingredients

Ingredient	Strength
PEXIDARTINIB HYDROCHLORIDE	200 mg/1

OpenFDA Data

• SPL SET ID: 24c5a6f1-b640-4d14-b44b-dd293ed002b1
• Manufacturer:
  • Daiichi Sankyo Inc.
• UNII:
  • YS6WAI3XN7
• RxNorm Concept Unique ID - RxCUI:
  • 2183131
  • 2183125