FDA.reportPublic FDA data

Talzenna

Product NDC
0069-0655
11-digit product format
000690655
Labeler code
0069
Product ID
0069-0655_79f127ad-8339-4132-a957-efae653394fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
talazoparib
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA217439
Marketing category
NDA
Marketing start
2024-04-17
Substance
TALAZOPARIB TOSYLATE
Active strength
.75 mg/1
Pharmacologic classes
Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Talzenna
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TALAZOPARIB TOSYLATE.75 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
0069-0655-30Talzenna30 in 1 BOTTLECAPSULE, LIQUID FILLED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0655-30EA - Each0069-0655a780bb87-9c77-445b-9846-56fda5c2a2db12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0655TALZENNA (TALAZOPARIB) CAPSULE, LIQUID FILLED [PFIZER LABORATORIES DIV PFIZER INC]2Current NDC, 1 package rows20250406_c6fd147f-a77e-4a0b-9280-e82ecc41b4be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2639960talazoparib 0.1 MG Oral CapsulePSNc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2099946talazoparib 0.25 MG Oral CapsulePSNc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2639964talazoparib 0.35 MG Oral CapsulePSNc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2591510talazoparib 0.5 MG Oral CapsulePSNc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2591520talazoparib 0.75 MG Oral CapsulePSNc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2099954talazoparib 1 MG Oral CapsulePSNc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2639962Talzenna 0.1 MG Oral CapsulePSNc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2099952Talzenna 0.25 MG Oral CapsulePSNc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2639966Talzenna 0.35 MG Oral CapsulePSNc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2591512Talzenna 0.5 MG Oral CapsulePSNc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2591521Talzenna 0.75 MG Oral CapsulePSNc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2099956Talzenna 1 MG Oral CapsulePSNc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2639962talazoparib 0.1 MG Oral Capsule [Talzenna]SBDc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2099952talazoparib 0.25 MG Oral Capsule [Talzenna]SBDc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2639966talazoparib 0.35 MG Oral Capsule [Talzenna]SBDc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2591512talazoparib 0.5 MG Oral Capsule [Talzenna]SBDc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2591521talazoparib 0.75 MG Oral Capsule [Talzenna]SBDc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2099956talazoparib 1 MG Oral Capsule [Talzenna]SBDc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2639960talazoparib 0.1 MG Oral CapsuleSCDc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2099946talazoparib 0.25 MG Oral CapsuleSCDc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2639964talazoparib 0.35 MG Oral CapsuleSCDc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2591510talazoparib 0.5 MG Oral CapsuleSCDc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2591520talazoparib 0.75 MG Oral CapsuleSCDc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2099954talazoparib 1 MG Oral CapsuleSCDc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2639960talazoparib 0.1 MG (as talazoparib tosylate 0.145 MG) Oral CapsuleSYc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2099946talazoparib 0.25 MG (as talazoparib tosylate 0.363 MG) Oral CapsuleSYc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2099952talazoparib 0.25 MG (as talazoparib tosylate 0.363 MG) Oral Capsule [Talzenna]SYc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2639964talazoparib 0.35 MG (as talazoparib tosylate 0.509 MG) Oral CapsuleSYc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2591510talazoparib 0.5 MG (as talazoparib tosylate 0.727 MG) Oral CapsuleSYc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2591520talazoparib 0.75 MG (as talazoparib tosylate 1.09 MG) Oral CapsuleSYc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2099954talazoparib 1 MG (as talazoparib tosylate 1.453 MG) Oral CapsuleSYc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2639962Talzenna 0.1 MG (as talazoparib tosylate 0.145 MG) Oral CapsuleSYc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2099952Talzenna 0.25 MG Oral CapsuleSYc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2639966Talzenna 0.35 MG (as talazoparib tosylate 0.509 MG) Oral CapsuleSYc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2591512Talzenna 0.5 MG Oral CapsuleSYc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2591521Talzenna 0.75 MG Oral CapsuleSYc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2099956Talzenna 1 MG (as talazoparib tosylate 1.453 MG) Oral CapsuleSYc6fd147f-a77e-4a0b-9280-e82ecc41b4be4
2099956Talzenna 1 MG Oral CapsuleSYc6fd147f-a77e-4a0b-9280-e82ecc41b4be4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0069-0655-300006906553030 CAPSULE, LIQUID FILLED in 1 BOTTLE (0069-0655-30) 2024-04-17NoNoHistorical