Talzenna
- Product NDC
- 63539-051
- 11-digit product format
- 635390051
- Labeler code
- 63539
- Product ID
- 63539-051_0e981f94-fca4-43e8-b88a-4b4b844f8edc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- talazoparib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- U.S. Pharmaceuticals
- Application
- NDA211651
- Marketing category
- NDA
- Marketing start
- 2023-06-21
- Marketing end
- 2026-06-30
- Substance
- TALAZOPARIB TOSYLATE
- Active strength
- .5 mg/1
- Pharmacologic classes
- Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 02WK9U5NZC | TALAZOPARIB TOSYLATE | 1373431-65-2 | TALAZOPARIB TOSYLATE |
| 9QHX048FRV | TALAZOPARIB | 1207456-01-6 | talazoparib |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63539-051-30 | 63539005130 | 1 BOTTLE in 1 CARTON (63539-051-30) / 30 CAPSULE in 1 BOTTLE | 1 bottle | 2023-06-21 | 2026-06-30 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Talzenna | U.S. Pharmaceuticals | Pfizer Inc | Pharmacia & Upjohn Company LLC | SGS Institut Fresenius GmbH | Sharp Packaging Services, LLC | 2025-06-19 | HUMAN PRESCRIPTION DRUG LABEL | 9 |