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
Routes
ORAL
Active Ingredients

talazoparib tosylate 1 mg/1

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-1195
Product ID 0069-1195_e189da1b-d503-48a4-aba3-4f93a3fab2d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211651
Marketing Start 2018-10-26
Marketing End 2027-08-31

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 00691195
Hyphenated Format 0069-1195

Supplemental Identifiers

RxCUI
2099946 2099952 2099954 2099956 2591510 2591512 2591520 2591521 2639960 2639962 2639964 2639966
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 (0069-1195-30) / 30 CAPSULE in 1 BOTTLE
source: ndc

Packages (1)

0069-1195-30 1 BOTTLE in 1 CARTON (0069-1195-30) / 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": "e189da1b-d503-48a4-aba3-4f93a3fab2d3", "openfda": {"unii": ["02WK9U5NZC"], "rxcui": ["2099946", "2099952", "2099954", "2099956", "2591510", "2591512", "2591520", "2591521", "2639960", "2639962", "2639964", "2639966"], "spl_set_id": ["f2423edd-6d24-495c-aec1-c2f457f08d9a"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0069-1195-30)  / 30 CAPSULE in 1 BOTTLE", "package_ndc": "0069-1195-30", "marketing_end_date": "20270831", "marketing_start_date": "20181026"}], "brand_name": "Talzenna", "product_id": "0069-1195_e189da1b-d503-48a4-aba3-4f93a3fab2d3", "dosage_form": "CAPSULE", "pharm_class": ["Poly(ADP-Ribose) Polymerase Inhibitor [EPC]", "Poly(ADP-Ribose) Polymerase Inhibitors [MoA]"], "product_ndc": "0069-1195", "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": "1 mg/1"}], "application_number": "NDA211651", "marketing_category": "NDA", "marketing_end_date": "20270831", "marketing_start_date": "20181026"}