NDC 63539-295

Talzenna

Talazoparib

Talzenna is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by U.s. Pharmaceuticals. The primary component is Talazoparib Tosylate.

• Product ID: 63539-295_2b72fd4a-5bfe-4c4e-8ab1-b2945e0a072a
• NDC: 63539-295
• 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: U.S. Pharmaceuticals
• Substance Name: TALAZOPARIB TOSYLATE
• Active Ingredient Strength: 1 mg/1
• Pharm Classes: Poly(ADP-Ribose) Polymerase Inhibitor [EPC],Poly(ADP-Ribose) Polymerase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63539-295-30

30 CAPSULE in 1 BOTTLE (63539-295-30)

• Marketing Start Date: 2018-12-10
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 63539-295-30 [63539029530]

Talzenna CAPSULE

• Marketing Category: NDA
• Application Number: NDA211651
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-12-10

Drug Details

Active Ingredients

Ingredient	Strength
TALAZOPARIB TOSYLATE	1 mg/1

OpenFDA Data

• SPL SET ID: 13839d4f-6acf-4ffb-a128-79df59319273
• Manufacturer:
  • U.S. Pharmaceuticals
• UNII:
  • 02WK9U5NZC
• RxNorm Concept Unique ID - RxCUI:
  • 2099954
  • 2099956

Pharmacological Class

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