talzenna

Generic: talazoparib

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name talzenna
Generic Name talazoparib
Labeler pfizer laboratories div pfizer inc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

talazoparib tosylate .75 mg/1

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-0655
Product ID 0069-0655_ab1b5af3-e7f1-46ac-8953-574c9924ccea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217439
Listing Expiration 2026-12-31
Marketing Start 2024-04-17

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 00690655
Hyphenated Format 0069-0655

Supplemental Identifiers

RxCUI
2099946 2099952 2099954 2099956 2591510 2591512 2591520 2591521 2639960 2639962 2639964 2639966
UPC
0300690353302 0300690252308 0300690757308 0300690454306 0300690546308
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 NDA217439 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .75 mg/1
source: ndc
Packaging
  • 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (0069-0655-30)
source: ndc

Packages (1)

Ingredients (1)

talazoparib tosylate (.75 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "ab1b5af3-e7f1-46ac-8953-574c9924ccea", "openfda": {"upc": ["0300690353302", "0300690252308", "0300690757308", "0300690454306", "0300690546308"], "unii": ["02WK9U5NZC"], "rxcui": ["2099946", "2099952", "2099954", "2099956", "2591510", "2591512", "2591520", "2591521", "2639960", "2639962", "2639964", "2639966"], "spl_set_id": ["c6fd147f-a77e-4a0b-9280-e82ecc41b4be"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (0069-0655-30)", "package_ndc": "0069-0655-30", "marketing_start_date": "20240417"}], "brand_name": "Talzenna", "product_id": "0069-0655_ab1b5af3-e7f1-46ac-8953-574c9924ccea", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Poly(ADP-Ribose) Polymerase Inhibitor [EPC]", "Poly(ADP-Ribose) Polymerase Inhibitors [MoA]"], "product_ndc": "0069-0655", "generic_name": "talazoparib", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Talzenna", "active_ingredients": [{"name": "TALAZOPARIB TOSYLATE", "strength": ".75 mg/1"}], "application_number": "NDA217439", "marketing_category": "NDA", "marketing_start_date": "20240417", "listing_expiration_date": "20261231"}