NDC 0469-0125

Xtandi

Enzalutamide

Xtandi is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Astellas Pharma Us, Inc.. The primary component is Enzalutamide.

• Product ID: 0469-0125_25c3a7dd-b2f0-4188-a4c3-9ccc694ca7a9
• NDC: 0469-0125
• Product Type: Human Prescription Drug
• Proprietary Name: Xtandi
• Generic Name: Enzalutamide
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2012-08-31
• Marketing Category: NDA / NDA
• Application Number: NDA203415
• Labeler Name: Astellas Pharma US, Inc.
• Substance Name: ENZALUTAMIDE
• Active Ingredient Strength: 40 mg/1
• Pharm Classes: Androgen Receptor Inhibitor [EPC],Androgen Receptor Antagonists [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0469-0125-99

1 BOTTLE in 1 CARTON (0469-0125-99) > 120 CAPSULE in 1 BOTTLE

• Marketing Start Date: 2012-08-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0469-0125-99 [00469012599]

Xtandi CAPSULE

• Marketing Category: NDA
• Application Number: NDA203415
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-08-31

Drug Details

Active Ingredients

Ingredient	Strength
ENZALUTAMIDE	40 mg/1

OpenFDA Data

• SPL SET ID: b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf
• Manufacturer:
  • Astellas Pharma US, Inc.
• UNII:
  • 93T0T9GKNU
• RxNorm Concept Unique ID - RxCUI:
  • 1307309
  • 1307303
• UPC Code:
  • 0304690125990

Pharmacological Class

• Androgen Receptor Inhibitor [EPC]
• Androgen Receptor Antagonists [MoA]
• Cytochrome P450 3A4 Inducers [MoA]
• Cytochrome P450 2C9 Inducers [MoA]
• Cytochrome P450 2C19 Inducers [MoA]

NDC Crossover Matching brand name "Xtandi" or generic name "Enzalutamide"

NDC	Brand Name	Generic Name
0469-0125	Xtandi	enzalutamide
0469-0625	Xtandi	enzalutamide
0469-0725	Xtandi	enzalutamide
0469-1125	Xtandi	enzalutamide
0469-1725	Xtandi	enzalutamide