Talzenna
- Product NDC
- 63539-295
- 11-digit product format
- 635390295
- Labeler code
- 63539
- Product ID
- 63539-295_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
- 2018-12-10
- Marketing end
- 2027-01-31
- Substance
- TALAZOPARIB TOSYLATE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Talzenna
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TALAZOPARIB TOSYLATE | 1 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 |
|---|
| 63539-295-30 | Talzenna | 30 in 1 BOTTLE | CAPSULE | 30 | | 9 |
| 63539-295-30 | Talzenna | 1 in 1 CARTON | CAPSULE | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63539-295 | TALZENNA (TALAZOPARIB) CAPSULE [U.S. PHARMACEUTICALS] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250406_13839d4f-6acf-4ffb-a128-79df59319273.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63539-295-30 | 63539029530 | 1 BOTTLE in 1 CARTON (63539-295-30) / 30 CAPSULE in 1 BOTTLE | 1 bottle | 2018-12-10 | 2027-01-31 | No | No | Current |