Talzenna
- Product NDC
- 63539-025
- 11-digit product format
- 635390025
- Labeler code
- 63539
- Product ID
- 63539-025_b653221e-971f-4452-92d4-797924f1ff59
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- talazoparib
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- U.S. Pharmaceuticals
- Application
- NDA217439
- Marketing category
- NDA
- Marketing start
- 2024-07-09
- 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
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Talzenna
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TALAZOPARIB TOSYLATE | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 02WK9U5NZC |
| Rxcui | 2099954, 2099956, 2591510, 2591512 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63539-025-30 | Talzenna | 30 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 63539-025-30 | 63539002530 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (63539-025-30) | 2024-07-09 | No | No | Historical |