Prescription drug · NDA
Talzenna (Talazoparib) NDC 63539-031
Talazoparib tosylate 1 mg/1 · Capsule, Liquid filled · Oral · U.S. Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63539-031-30 | 6353900313063539003130 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (63539-031-30)Marketed from Jul 9, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Talzenna
- Generic name (nonproprietary)
- talazoparib
- Active ingredients
- Talazoparib tosylate — 1 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- U.S. PharmaceuticalsNDC labeler code 63539
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217439
- Marketing start
- Listing expires
- Other FDA classes
- Poly(ADP-Ribose) Polymerase Inhibitors (Mechanism)
- Identifiers
- Product ID 63539-031_b653221e-971f-4452-92d4-797924f1ff59SPL ID b653221e-971f-4452-92d4-797924f1ff59SPL set ID b653221e-971f-4452-92d4-797924f1ff59RxCUI 2099954, 2099956, 2591510, 2591512UNII 02WK9U5NZC
- Pharmacologic class
- Poly(ADP-Ribose) Polymerase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N463539003130followed by a unit qualifier and the quantityPackage 63539-0031-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for: Breast Cancer • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. ( 1.1 ) HRR Gene-Mutated mCRPC • In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). ( 1.2 ) 1.1 BRCA -mutated (g BRCA m) HER2-negative Locally Advanced or Metastatic Breast Cancer TALZENNA is indicated as a single agent for the treat…
Excerpt only. Read the full label for complete information.
About NDC 63539-031
- What is NDC 63539-031?
- 63539-031 is the product NDC for Talzenna (talazoparib), Talazoparib tosylate 1 mg/1 capsule, liquid filled, listed with the FDA by U.S. Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Talzenna (Talazoparib).
- What is the active ingredient?
- Talazoparib tosylate.
- Who is the labeler?
- U.S. Pharmaceuticals, NDC labeler code 63539. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Talzenna?
- 11 other product NDCs are listed under this name. See all Talzenna NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Talzenna products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Talzennatalazoparib | Talazoparib tosylate .5 mg/1 | Capsule, Liquid filledOral | U.S. Pharmaceuticals | 63539-025 | 63539-0025-30 |
| Talzennatalazoparib | Talazoparib tosylate .1 mg/1 | Capsule, Liquid filledOral | Pfizer Laboratories Div Pfizer Inc | 0069-0252 | 00069-0252-30 |
| Talzennatalazoparib | Talazoparib tosylate .25 mg/1 | Capsule, Liquid filledOral | Pfizer Laboratories Div Pfizer Inc | 0069-0353 | 00069-0353-30 |
| Talzennatalazoparib | Talazoparib tosylate .35 mg/1 | Capsule, Liquid filledOral | Pfizer Laboratories Div Pfizer Inc | 0069-0454 | 00069-0454-30 |
| Talzennatalazoparib | Talazoparib tosylate .5 mg/1 | Capsule, Liquid filledOral | Pfizer Laboratories Div Pfizer Inc | 0069-0546 | 00069-0546-30 |
| Talzennatalazoparib | Talazoparib tosylate .75 mg/1 | Capsule, Liquid filledOral | Pfizer Laboratories Div Pfizer Inc | 0069-0655 | 00069-0655-30 |
| Talzennatalazoparib | Talazoparib tosylate 1 mg/1 | Capsule, Liquid filledOral | Pfizer Laboratories Div Pfizer Inc | 0069-0757 | 00069-0757-30 |
| Talzennatalazoparib | Talazoparib tosylate .5 mg/1 | CapsuleOral | Pfizer Laboratories Div Pfizer Inc | 0069-1501 | 00069-1501-30 |
| Talzennatalazoparib | Talazoparib tosylate 1 mg/1 | CapsuleOral | U.S. Pharmaceuticals | 63539-295 | 63539-0295-30 |
| Talzennatalazoparib | Talazoparib tosylate .25 mg/1 | CapsuleOral | Pfizer Laboratories Div Pfizer Inc | 0069-0296 | 00069-0296-30 |
Other NDCs under NDA 217439
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Talzennatalazoparib | Talazoparib tosylate .1 mg/1 | Capsule, Liquid filledOral | Pfizer Laboratories Div Pfizer Inc | 0069-0252 |
| Talzennatalazoparib | Talazoparib tosylate .25 mg/1 | Capsule, Liquid filledOral | Pfizer Laboratories Div Pfizer Inc | 0069-0353 |
| Talzennatalazoparib | Talazoparib tosylate .35 mg/1 | Capsule, Liquid filledOral | Pfizer Laboratories Div Pfizer Inc | 0069-0454 |
| Talzennatalazoparib | Talazoparib tosylate .5 mg/1 | Capsule, Liquid filledOral | Pfizer Laboratories Div Pfizer Inc | 0069-0546 |
| Talzennatalazoparib | Talazoparib tosylate .75 mg/1 | Capsule, Liquid filledOral | Pfizer Laboratories Div Pfizer Inc | 0069-0655 |
| Talzennatalazoparib | Talazoparib tosylate 1 mg/1 | Capsule, Liquid filledOral | Pfizer Laboratories Div Pfizer Inc | 0069-0757 |
| Talzennatalazoparib | Talazoparib tosylate .5 mg/1 | Capsule, Liquid filledOral | U.S. Pharmaceuticals | 63539-025 |