talzenna

Generic: talazoparib

Labeler: u.s. pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name talzenna
Generic Name talazoparib
Labeler u.s. pharmaceuticals
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

talazoparib tosylate 1 mg/1

Manufacturer
U.S. Pharmaceuticals

Identifiers & Regulatory

Product NDC 63539-295
Product ID 63539-295_0e981f94-fca4-43e8-b88a-4b4b844f8edc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211651
Marketing Start 2018-12-10
Marketing End 2027-01-31

Pharmacologic Class

Classes
poly(adp-ribose) polymerase inhibitor [epc] poly(adp-ribose) polymerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63539295
Hyphenated Format 63539-295

Supplemental Identifiers

RxCUI
2099954 2099956 2591510 2591512
UNII
02WK9U5NZC

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name talzenna (source: ndc)
Generic Name talazoparib (source: ndc)
Application Number NDA211651 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (63539-295-30) / 30 CAPSULE in 1 BOTTLE
source: ndc

Packages (1)

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

Ingredients (1)

talazoparib tosylate (1 mg/1)

Linked Drug Pages (1)

Talzenna ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0e981f94-fca4-43e8-b88a-4b4b844f8edc", "openfda": {"unii": ["02WK9U5NZC"], "rxcui": ["2099954", "2099956", "2591510", "2591512"], "spl_set_id": ["13839d4f-6acf-4ffb-a128-79df59319273"], "manufacturer_name": ["U.S. Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (63539-295-30)  / 30 CAPSULE in 1 BOTTLE", "package_ndc": "63539-295-30", "marketing_end_date": "20270131", "marketing_start_date": "20181210"}], "brand_name": "Talzenna", "product_id": "63539-295_0e981f94-fca4-43e8-b88a-4b4b844f8edc", "dosage_form": "CAPSULE", "pharm_class": ["Poly(ADP-Ribose) Polymerase Inhibitor [EPC]", "Poly(ADP-Ribose) Polymerase Inhibitors [MoA]"], "product_ndc": "63539-295", "generic_name": "talazoparib", "labeler_name": "U.S. Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Talzenna", "active_ingredients": [{"name": "TALAZOPARIB TOSYLATE", "strength": "1 mg/1"}], "application_number": "NDA211651", "marketing_category": "NDA", "marketing_end_date": "20270131", "marketing_start_date": "20181210"}