FDA.reportPublic FDA data

Talzenna

Product NDC
63539-051
11-digit product format
635390051
Labeler code
63539
Product ID
63539-051_0e981f94-fca4-43e8-b88a-4b4b844f8edc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
talazoparib
Dosage form
CAPSULE
Route
ORAL
Labeler
U.S. Pharmaceuticals
Application
NDA211651
Marketing category
NDA
Marketing start
2023-06-21
Marketing end
2026-06-30
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63539-051DDiscontinued by firm2026-07-31
excluded packagepackage63539-05163539-051-30DDiscontinued by firm2026-07-31

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
N211651-001TALZENNATALAZOPARIB TOSYLATEEQ 0.25MG BASECAPSULE / ORALRLD2018-10-16
N211651-002TALZENNATALAZOPARIB TOSYLATEEQ 1MG BASECAPSULE / ORALRLD2018-10-16
N211651-003TALZENNATALAZOPARIB TOSYLATEEQ 0.5MG BASECAPSULE / ORALRLD2021-09-20
N211651-004TALZENNATALAZOPARIB TOSYLATEEQ 0.75MG BASECAPSULE / ORALRLD2021-09-20
N211651-005TALZENNATALAZOPARIB TOSYLATEEQ 0.1MG BASECAPSULE / ORALRLD2023-06-20
N211651-006TALZENNATALAZOPARIB TOSYLATEEQ 0.35MG BASECAPSULE / ORALRLD2023-06-20

Orange Book patents#

Current patent rows page 1 of 1 · 34 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N211651-001107800882029-07-27U-36512023-07-19
N211651-00180129762029-07-27Drug substance, Drug product2018-11-14
N211651-00184206502029-07-27Drug substance, Drug product2018-11-14
N211651-00198209852029-07-27U-24372018-11-14
N211651-001101898372031-10-20Drug substance, Drug product2019-02-27
N211651-00187353922031-10-20Drug substance, Drug product2018-11-14
N211651-00280129762029-07-27Drug substance, Drug product2018-11-14
N211651-00284206502029-07-27Drug substance, Drug product2018-11-14
N211651-00298209852029-07-27U-24372018-11-14
N211651-002101898372031-10-20Drug substance, Drug product2019-02-27
N211651-00287353922031-10-20Drug substance, Drug product2018-11-14
N211651-003107800882029-07-27U-36512023-07-19
N211651-00380129762029-07-27Drug substance, Drug product2021-10-19
N211651-00384206502029-07-27Drug substance, Drug product2021-10-19
N211651-00398209852029-07-27U-24372021-10-19
N211651-003101898372031-10-20Drug substance, Drug product2021-10-19
N211651-00387353922031-10-20Drug substance, Drug product2021-10-19
N211651-00480129762029-07-27Drug substance, Drug product2021-10-19
N211651-00484206502029-07-27Drug substance, Drug product2021-10-19
N211651-00498209852029-07-27U-24372021-10-19
N211651-004101898372031-10-20Drug substance, Drug product2021-10-19
N211651-00487353922031-10-20Drug substance, Drug product2021-10-19
N211651-005107800882029-07-27U-36512023-07-19
N211651-00580129762029-07-27Drug substance, Drug product2023-07-19
N211651-00584206502029-07-27Drug substance, Drug product2023-07-19
N211651-00598209852029-07-27U-24372023-07-19
N211651-005101898372031-10-20Drug substance, Drug product2023-07-19
N211651-00587353922031-10-20Drug substance, Drug product2023-07-19
N211651-006107800882029-07-27U-36512023-07-19
N211651-00680129762029-07-27Drug substance, Drug product2023-07-19
N211651-00684206502029-07-27Drug substance, Drug product2023-07-19
N211651-00698209852029-07-27U-24372023-07-19
N211651-006101898372031-10-20Drug substance, Drug product2023-07-19
N211651-00687353922031-10-20Drug substance, Drug product2023-07-19

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N211651-001I-9202026-06-20
N211651-003I-9202026-06-20
N211651-005I-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 22:54:322026-06N211651-001TALZENNAEQ 0.25MG BASECAPSULE / ORALRLD2018-10-16a50c72e98297…
2026-08-01 22:54:322026-06N211651-002TALZENNAEQ 1MG BASECAPSULE / ORALRLD2018-10-16a50c72e98297…
2026-08-01 22:54:322026-06N211651-003TALZENNAEQ 0.5MG BASECAPSULE / ORALRLD2021-09-20a50c72e98297…
2026-08-01 22:54:322026-06N211651-004TALZENNAEQ 0.75MG BASECAPSULE / ORALRLD2021-09-20a50c72e98297…
2026-08-01 22:54:322026-06N211651-005TALZENNAEQ 0.1MG BASECAPSULE / ORALRLD2023-06-20a50c72e98297…
2026-08-01 22:54:322026-06N211651-006TALZENNAEQ 0.35MG BASECAPSULE / ORALRLD2023-06-20a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N211651-001107800882029-07-27U-36512023-07-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-00180129762029-07-27Drug substance, Drug product2018-11-14a50c72e98297…
2026-08-01 22:54:322026-06N211651-00184206502029-07-27Drug substance, Drug product2018-11-14a50c72e98297…
2026-08-01 22:54:322026-06N211651-00198209852029-07-27U-24372018-11-14a50c72e98297…
2026-08-01 22:54:322026-06N211651-001101898372031-10-20Drug substance, Drug product2019-02-27a50c72e98297…
2026-08-01 22:54:322026-06N211651-00187353922031-10-20Drug substance, Drug product2018-11-14a50c72e98297…
2026-08-01 22:54:322026-06N211651-00280129762029-07-27Drug substance, Drug product2018-11-14a50c72e98297…
2026-08-01 22:54:322026-06N211651-00284206502029-07-27Drug substance, Drug product2018-11-14a50c72e98297…
2026-08-01 22:54:322026-06N211651-00298209852029-07-27U-24372018-11-14a50c72e98297…
2026-08-01 22:54:322026-06N211651-002101898372031-10-20Drug substance, Drug product2019-02-27a50c72e98297…
2026-08-01 22:54:322026-06N211651-00287353922031-10-20Drug substance, Drug product2018-11-14a50c72e98297…
2026-08-01 22:54:322026-06N211651-003107800882029-07-27U-36512023-07-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-00380129762029-07-27Drug substance, Drug product2021-10-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-00384206502029-07-27Drug substance, Drug product2021-10-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-00398209852029-07-27U-24372021-10-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-003101898372031-10-20Drug substance, Drug product2021-10-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-00387353922031-10-20Drug substance, Drug product2021-10-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-00480129762029-07-27Drug substance, Drug product2021-10-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-00484206502029-07-27Drug substance, Drug product2021-10-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-00498209852029-07-27U-24372021-10-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-004101898372031-10-20Drug substance, Drug product2021-10-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-00487353922031-10-20Drug substance, Drug product2021-10-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-005107800882029-07-27U-36512023-07-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-00580129762029-07-27Drug substance, Drug product2023-07-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-00584206502029-07-27Drug substance, Drug product2023-07-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-00598209852029-07-27U-24372023-07-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-005101898372031-10-20Drug substance, Drug product2023-07-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-00587353922031-10-20Drug substance, Drug product2023-07-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-006107800882029-07-27U-36512023-07-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-00680129762029-07-27Drug substance, Drug product2023-07-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-00684206502029-07-27Drug substance, Drug product2023-07-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-00698209852029-07-27U-24372023-07-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-006101898372031-10-20Drug substance, Drug product2023-07-19a50c72e98297…
2026-08-01 22:54:322026-06N211651-00687353922031-10-20Drug substance, Drug product2023-07-19a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N211651-001I-9202026-06-20a50c72e98297…
2026-08-01 22:54:322026-06N211651-003I-9202026-06-20a50c72e98297…
2026-08-01 22:54:322026-06N211651-005I-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
TalzennaTALAZOPARIBU.S. Pharmaceuticals13839d4f-6acf-4ffb-a128-79df593192732026-06-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 211651
application number: NDA211651
ndc (product): 63539-051
TalzennaTALAZOPARIBPfizer Laboratories Div Pfizer Incf2423edd-6d24-495c-aec1-c2f457f08d9a2025-12-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 211651
application number: NDA211651

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
63539-051-30Talzenna1 in 1 CARTONCAPSULE19
63539-051-30Talzenna30 in 1 BOTTLECAPSULE309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63539-051TALZENNA (TALAZOPARIB) CAPSULE [U.S. PHARMACEUTICALS]8Current NDC, 2 package rows20250406_13839d4f-6acf-4ffb-a128-79df59319273.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63539-051-30635390051301 BOTTLE in 1 CARTON (63539-051-30) / 30 CAPSULE in 1 BOTTLE1 bottle2023-06-212026-06-30NoNoHistorical