FDA.reportPublic FDA data

Talzenna

Product NDC
0069-1501
11-digit product format
000691501
Labeler code
0069
Product ID
0069-1501_e189da1b-d503-48a4-aba3-4f93a3fab2d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
talazoparib
Dosage form
CAPSULE
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA211651
Marketing category
NDA
Marketing start
2022-01-31
Marketing end
2027-03-31
Substance
TALAZOPARIB TOSYLATE
Active strength
.5 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
IngredientStrength
TALAZOPARIB TOSYLATE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii02WK9U5NZC
Rxcui2099946, 2099952, 2099954, 2099956, 2591510, 2591512, 2591520, 2591521, 2639960, 2639962, 2639964, 2639966

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f22ae3e-e8f8-4cc5-86db-e9dcae189816Product name120250123
ee7ffa9d-6478-411c-a335-77574996aac2Product name120190125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-1501-30Talzenna30 in 1 BOTTLECAPSULE3019
0069-1501-30Talzenna1 in 1 CARTONCAPSULE119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-1501-30EA - Each0069-1501dc0618ad-a1d9-4d61-af8b-fe88298e350212022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-1501TALZENNA (TALAZOPARIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]17Current NDC, Legacy NDC, 2 package rows20250406_f2423edd-6d24-495c-aec1-c2f457f08d9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2639960talazoparib 0.1 MG Oral CapsulePSNf2423edd-6d24-495c-aec1-c2f457f08d9a19
2099946talazoparib 0.25 MG Oral CapsulePSNf2423edd-6d24-495c-aec1-c2f457f08d9a19
2639964talazoparib 0.35 MG Oral CapsulePSNf2423edd-6d24-495c-aec1-c2f457f08d9a19
2591510talazoparib 0.5 MG Oral CapsulePSNf2423edd-6d24-495c-aec1-c2f457f08d9a19
2591520talazoparib 0.75 MG Oral CapsulePSNf2423edd-6d24-495c-aec1-c2f457f08d9a19
2099954talazoparib 1 MG Oral CapsulePSNf2423edd-6d24-495c-aec1-c2f457f08d9a19
2639962Talzenna 0.1 MG Oral CapsulePSNf2423edd-6d24-495c-aec1-c2f457f08d9a19
2099952Talzenna 0.25 MG Oral CapsulePSNf2423edd-6d24-495c-aec1-c2f457f08d9a19
2639966Talzenna 0.35 MG Oral CapsulePSNf2423edd-6d24-495c-aec1-c2f457f08d9a19
2591512Talzenna 0.5 MG Oral CapsulePSNf2423edd-6d24-495c-aec1-c2f457f08d9a19
2591521Talzenna 0.75 MG Oral CapsulePSNf2423edd-6d24-495c-aec1-c2f457f08d9a19
2099956Talzenna 1 MG Oral CapsulePSNf2423edd-6d24-495c-aec1-c2f457f08d9a19
2639962talazoparib 0.1 MG Oral Capsule [Talzenna]SBDf2423edd-6d24-495c-aec1-c2f457f08d9a19
2099952talazoparib 0.25 MG Oral Capsule [Talzenna]SBDf2423edd-6d24-495c-aec1-c2f457f08d9a19
2639966talazoparib 0.35 MG Oral Capsule [Talzenna]SBDf2423edd-6d24-495c-aec1-c2f457f08d9a19
2591512talazoparib 0.5 MG Oral Capsule [Talzenna]SBDf2423edd-6d24-495c-aec1-c2f457f08d9a19
2591521talazoparib 0.75 MG Oral Capsule [Talzenna]SBDf2423edd-6d24-495c-aec1-c2f457f08d9a19
2099956talazoparib 1 MG Oral Capsule [Talzenna]SBDf2423edd-6d24-495c-aec1-c2f457f08d9a19
2639960talazoparib 0.1 MG Oral CapsuleSCDf2423edd-6d24-495c-aec1-c2f457f08d9a19
2099946talazoparib 0.25 MG Oral CapsuleSCDf2423edd-6d24-495c-aec1-c2f457f08d9a19
2639964talazoparib 0.35 MG Oral CapsuleSCDf2423edd-6d24-495c-aec1-c2f457f08d9a19
2591510talazoparib 0.5 MG Oral CapsuleSCDf2423edd-6d24-495c-aec1-c2f457f08d9a19
2591520talazoparib 0.75 MG Oral CapsuleSCDf2423edd-6d24-495c-aec1-c2f457f08d9a19
2099954talazoparib 1 MG Oral CapsuleSCDf2423edd-6d24-495c-aec1-c2f457f08d9a19
2639960talazoparib 0.1 MG (as talazoparib tosylate 0.145 MG) Oral CapsuleSYf2423edd-6d24-495c-aec1-c2f457f08d9a19
2099946talazoparib 0.25 MG (as talazoparib tosylate 0.363 MG) Oral CapsuleSYf2423edd-6d24-495c-aec1-c2f457f08d9a19
2099952talazoparib 0.25 MG (as talazoparib tosylate 0.363 MG) Oral Capsule [Talzenna]SYf2423edd-6d24-495c-aec1-c2f457f08d9a19
2639964talazoparib 0.35 MG (as talazoparib tosylate 0.509 MG) Oral CapsuleSYf2423edd-6d24-495c-aec1-c2f457f08d9a19
2591510talazoparib 0.5 MG (as talazoparib tosylate 0.727 MG) Oral CapsuleSYf2423edd-6d24-495c-aec1-c2f457f08d9a19
2591520talazoparib 0.75 MG (as talazoparib tosylate 1.09 MG) Oral CapsuleSYf2423edd-6d24-495c-aec1-c2f457f08d9a19
2099954talazoparib 1 MG (as talazoparib tosylate 1.453 MG) Oral CapsuleSYf2423edd-6d24-495c-aec1-c2f457f08d9a19
2639962Talzenna 0.1 MG (as talazoparib tosylate 0.145 MG) Oral CapsuleSYf2423edd-6d24-495c-aec1-c2f457f08d9a19
2099952Talzenna 0.25 MG Oral CapsuleSYf2423edd-6d24-495c-aec1-c2f457f08d9a19
2639966Talzenna 0.35 MG (as talazoparib tosylate 0.509 MG) Oral CapsuleSYf2423edd-6d24-495c-aec1-c2f457f08d9a19
2591512Talzenna 0.5 MG Oral CapsuleSYf2423edd-6d24-495c-aec1-c2f457f08d9a19
2591521Talzenna 0.75 MG Oral CapsuleSYf2423edd-6d24-495c-aec1-c2f457f08d9a19
2099956Talzenna 1 MG (as talazoparib tosylate 1.453 MG) Oral CapsuleSYf2423edd-6d24-495c-aec1-c2f457f08d9a19
2099956Talzenna 1 MG Oral CapsuleSYf2423edd-6d24-495c-aec1-c2f457f08d9a19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0069-1501-30000691501301 BOTTLE in 1 CARTON (0069-1501-30) / 30 CAPSULE in 1 BOTTLE1 bottle2022-01-312027-03-31NoNoCurrent