NDC 0469-1125

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: 0469-1125_2b95b0cc-a568-4587-9a46-39c72e892942
• NDC: 0469-1125
• 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 /
• Application Number: NDA203415
• Labeler Name: Astellas Pharma US, Inc.
• Substance Name: ENZALUTAMIDE
• Active Ingredient Strength: 40 mg/1
• Pharm Classes: Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0469-1125-56

56 CAPSULE in 1 BLISTER PACK (0469-1125-56)

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

Drug Details

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