FDA.reportPublic FDA data

Talzenna

Product NDC
63539-031
11-digit product format
635390031
Labeler code
63539
Product ID
63539-031_b653221e-971f-4452-92d4-797924f1ff59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
talazoparib
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
U.S. Pharmaceuticals
Application
NDA217439
Marketing category
NDA
Marketing start
2024-07-09
Substance
TALAZOPARIB TOSYLATE
Active strength
1 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
TalzennaTALAZOPARIBU.S. Pharmaceuticalsb653221e-971f-4452-92d4-797924f1ff592024-07-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 217439
application number: NDA217439
ndc (product): 63539-031

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TALAZOPARIB TOSYLATE1 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2099954Internal RxNorm lookup
2099956Internal RxNorm lookup
2591510Internal RxNorm lookup
2591512Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b653221e-971f-4452-92d4-797924f1ff59Available 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
63539-031-30Talzenna30 in 1 BOTTLECAPSULE, LIQUID FILLED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2591510talazoparib 0.5 MG Oral CapsulePSNb653221e-971f-4452-92d4-797924f1ff591
2099954talazoparib 1 MG Oral CapsulePSNb653221e-971f-4452-92d4-797924f1ff591
2591512Talzenna 0.5 MG Oral CapsulePSNb653221e-971f-4452-92d4-797924f1ff591
2099956Talzenna 1 MG Oral CapsulePSNb653221e-971f-4452-92d4-797924f1ff591
2591512talazoparib 0.5 MG Oral Capsule [Talzenna]SBDb653221e-971f-4452-92d4-797924f1ff591
2099956talazoparib 1 MG Oral Capsule [Talzenna]SBDb653221e-971f-4452-92d4-797924f1ff591
2591510talazoparib 0.5 MG Oral CapsuleSCDb653221e-971f-4452-92d4-797924f1ff591
2099954talazoparib 1 MG Oral CapsuleSCDb653221e-971f-4452-92d4-797924f1ff591
2591510talazoparib 0.5 MG (as talazoparib tosylate 0.727 MG) Oral CapsuleSYb653221e-971f-4452-92d4-797924f1ff591
2099954talazoparib 1 MG (as talazoparib tosylate 1.453 MG) Oral CapsuleSYb653221e-971f-4452-92d4-797924f1ff591
2591512Talzenna 0.5 MG Oral CapsuleSYb653221e-971f-4452-92d4-797924f1ff591
2099956Talzenna 1 MG (as talazoparib tosylate 1.453 MG) Oral CapsuleSYb653221e-971f-4452-92d4-797924f1ff591
2099956Talzenna 1 MG Oral CapsuleSYb653221e-971f-4452-92d4-797924f1ff591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63539-031-306353900313030 CAPSULE, LIQUID FILLED in 1 BOTTLE (63539-031-30) 2024-07-09NoNoCurrent