NDC 46014-1195

Talzenna

Talazoparib

Talzenna is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Excella Gmbh & Co. Kg. The primary component is Talazoparib Tos.

• Product ID: 46014-1195_84f244a3-ecbc-2887-e053-2991aa0acc2e
• NDC: 46014-1195
• Product Type: Human Prescription Drug
• Proprietary Name: Talzenna
• Generic Name: Talazoparib
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2018-10-26
• Marketing Category: NDA / NDA
• Application Number: NDA211651
• Labeler Name: Excella GmbH & Co. KG
• Substance Name: TALAZOPARIB TOS
• Active Ingredient Strength: 1 mg/1
• Pharm Classes: Poly(ADP-Ribose
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 46014-1195-3

30 CAPSULE in 1 BOTTLE (46014-1195-3)

• Marketing Start Date: 2018-10-26
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

Active Ingredients

Ingredient	Strength
TALAZOPARIB TOSYLATE	1 mg/1

OpenFDA Data

• SPL SET ID: 84f244a3-ecbb-2887-e053-2991aa0acc2e
• Manufacturer:
  • Excella GmbH & Co. KG
• UNII:
  • 02WK9U5NZC
• RxNorm Concept Unique ID - RxCUI:
  • 2099954
  • 2099956
  • 2099946
  • 2099952

Pharmacological Class

• Poly(ADP-Ribose) Polymerase Inhibitor [EPC]
• Poly(ADP-Ribose) Polymerase Inhibitors [MoA]

NDC Crossover Matching brand name "Talzenna" or generic name "Talazoparib"

NDC	Brand Name	Generic Name
0069-0296	Talzenna	talazoparib
0069-1195	Talzenna	talazoparib
0069-1501	Talzenna	talazoparib
0069-1751	Talzenna	talazoparib
46014-0296	Talzenna	talazoparib
46014-1195	Talzenna	talazoparib
63539-295	Talzenna	talazoparib