FDA.reportPublic FDA data

Talzenna

Product NDC
0069-0546
11-digit product format
000690546
Labeler code
0069
Product ID
0069-0546_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
.5 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217439-001TALZENNATALAZOPARIB TOSYLATEEQ 0.1MG BASECAPSULE / ORALRLD2024-03-07
N217439-002TALZENNATALAZOPARIB TOSYLATEEQ 0.25MG BASECAPSULE / ORALRLD2024-03-07
N217439-003TALZENNATALAZOPARIB TOSYLATEEQ 0.35MG BASECAPSULE / ORALRLD2024-03-07
N217439-004TALZENNATALAZOPARIB TOSYLATEEQ 0.5MG BASECAPSULE / ORALRLD2024-03-07
N217439-005TALZENNATALAZOPARIB TOSYLATEEQ 0.75MG BASECAPSULE / ORALRLD2024-03-07
N217439-006TALZENNATALAZOPARIB TOSYLATEEQ 1MG BASECAPSULE / ORALRLD, RS2024-03-07

Orange Book patents#

Current patent rows page 1 of 1 · 36 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217439-001107800882029-07-27U-36512024-04-05
N217439-00180129762029-07-27Drug substance, Drug product2024-04-05
N217439-00184206502029-07-27Drug substance, Drug product2024-04-05
N217439-00198209852029-07-27U-24372024-04-05
N217439-001101898372031-10-20Drug substance, Drug product2024-04-05
N217439-00187353922031-10-20Drug substance, Drug product2024-04-05
N217439-002107800882029-07-27U-36512024-04-05
N217439-00280129762029-07-27Drug substance, Drug product2024-04-05
N217439-00284206502029-07-27Drug substance, Drug product2024-04-05
N217439-00298209852029-07-27U-24372024-04-05
N217439-002101898372031-10-20Drug substance, Drug product2024-04-05
N217439-00287353922031-10-20Drug substance, Drug product2024-04-05
N217439-003107800882029-07-27U-36512024-04-05
N217439-00380129762029-07-27Drug substance, Drug product2024-04-05
N217439-00384206502029-07-27Drug substance, Drug product2024-04-05
N217439-00398209852029-07-27U-24372024-04-05
N217439-003101898372031-10-20Drug substance, Drug product2024-04-05
N217439-00387353922031-10-20Drug substance, Drug product2024-04-05
N217439-004107800882029-07-27U-36512024-04-05
N217439-00480129762029-07-27Drug substance, Drug product2024-04-05
N217439-00484206502029-07-27Drug substance, Drug product2024-04-05
N217439-00498209852029-07-27U-24372024-04-05
N217439-004101898372031-10-20Drug substance, Drug product2024-04-05
N217439-00487353922031-10-20Drug substance, Drug product2024-04-05
N217439-005107800882029-07-27U-36512024-04-05
N217439-00580129762029-07-27Drug substance, Drug product2024-04-05
N217439-00584206502029-07-27Drug substance, Drug product2024-04-05
N217439-00598209852029-07-27U-24372024-04-05
N217439-005101898372031-10-20Drug substance, Drug product2024-04-05
N217439-00587353922031-10-20Drug substance, Drug product2024-04-05
N217439-006107800882029-07-27U-36512024-04-05
N217439-00680129762029-07-27Drug substance, Drug product2024-04-05
N217439-00684206502029-07-27Drug substance, Drug product2024-04-05
N217439-00698209852029-07-27U-24372024-04-05
N217439-006101898372031-10-20Drug substance, Drug product2024-04-05
N217439-00687353922031-10-20Drug substance, Drug product2024-04-05

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217439-001I-9202026-06-20
N217439-002I-9202026-06-20
N217439-004I-9202026-06-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N217439-001TALZENNAEQ 0.1MG BASECAPSULE / ORALRLD2024-03-07a50c72e98297…
2026-08-01 22:54:322026-06N217439-002TALZENNAEQ 0.25MG BASECAPSULE / ORALRLD2024-03-07a50c72e98297…
2026-08-01 22:54:322026-06N217439-003TALZENNAEQ 0.35MG BASECAPSULE / ORALRLD2024-03-07a50c72e98297…
2026-08-01 22:54:322026-06N217439-004TALZENNAEQ 0.5MG BASECAPSULE / ORALRLD2024-03-07a50c72e98297…
2026-08-01 22:54:322026-06N217439-005TALZENNAEQ 0.75MG BASECAPSULE / ORALRLD2024-03-07a50c72e98297…
2026-08-01 22:54:322026-06N217439-006TALZENNAEQ 1MG BASECAPSULE / ORALRLD, RS2024-03-07a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N217439-001107800882029-07-27U-36512024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00180129762029-07-27Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00184206502029-07-27Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00198209852029-07-27U-24372024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-001101898372031-10-20Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00187353922031-10-20Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-002107800882029-07-27U-36512024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00280129762029-07-27Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00284206502029-07-27Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00298209852029-07-27U-24372024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-002101898372031-10-20Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00287353922031-10-20Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-003107800882029-07-27U-36512024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00380129762029-07-27Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00384206502029-07-27Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00398209852029-07-27U-24372024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-003101898372031-10-20Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00387353922031-10-20Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-004107800882029-07-27U-36512024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00480129762029-07-27Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00484206502029-07-27Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00498209852029-07-27U-24372024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-004101898372031-10-20Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00487353922031-10-20Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-005107800882029-07-27U-36512024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00580129762029-07-27Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00584206502029-07-27Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00598209852029-07-27U-24372024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-005101898372031-10-20Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00587353922031-10-20Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-006107800882029-07-27U-36512024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00680129762029-07-27Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00684206502029-07-27Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00698209852029-07-27U-24372024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-006101898372031-10-20Drug substance, Drug product2024-04-05a50c72e98297…
2026-08-01 22:54:322026-06N217439-00687353922031-10-20Drug substance, Drug product2024-04-05a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N217439-001I-9202026-06-20a50c72e98297…
2026-08-01 22:54:322026-06N217439-002I-9202026-06-20a50c72e98297…
2026-08-01 22:54:322026-06N217439-004I-9202026-06-20a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TalzennaTALAZOPARIBPfizer Laboratories Div Pfizer Incc6fd147f-a77e-4a0b-9280-e82ecc41b4be2026-04-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 217439
application number: NDA217439
ndc (product): 0069-0546
TalzennaTALAZOPARIBU.S. Pharmaceuticalsb653221e-971f-4452-92d4-797924f1ff592024-07-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 217439
application number: NDA217439

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TALAZOPARIB TOSYLATE.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
02WK9U5NZCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2099946Internal RxNorm lookup
2099952Internal RxNorm lookup
2099954Internal RxNorm lookup
2099956Internal RxNorm lookup
2591510Internal RxNorm lookup
2591512Internal RxNorm lookup
2591520Internal RxNorm lookup
2591521Internal RxNorm lookup
2639960Internal RxNorm lookup
2639962Internal RxNorm lookup
2639964Internal RxNorm lookup
2639966Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c6fd147f-a77e-4a0b-9280-e82ecc41b4beAvailable on FDA.report

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
0069-0546-30Talzenna30 in 1 BOTTLECAPSULE, LIQUID FILLED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0546-30EA - Each0069-05467c5a1ab2-9fb0-4a24-8a5f-7ab0995353e112024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0546TALZENNA (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
0069-0546-300006905463030 CAPSULE, LIQUID FILLED in 1 BOTTLE (0069-0546-30) 2024-04-17NoNoCurrent