Home NDC 0069-1501 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N211651-001 TALZENNA TALAZOPARIB TOSYLATE EQ 0.25MG BASE CAPSULE / ORAL RLD 2018-10-16 N211651-002 TALZENNA TALAZOPARIB TOSYLATE EQ 1MG BASE CAPSULE / ORAL RLD 2018-10-16 N211651-003 TALZENNA TALAZOPARIB TOSYLATE EQ 0.5MG BASE CAPSULE / ORAL RLD 2021-09-20 N211651-004 TALZENNA TALAZOPARIB TOSYLATE EQ 0.75MG BASE CAPSULE / ORAL RLD 2021-09-20 N211651-005 TALZENNA TALAZOPARIB TOSYLATE EQ 0.1MG BASE CAPSULE / ORAL RLD 2023-06-20 N211651-006 TALZENNA TALAZOPARIB TOSYLATE EQ 0.35MG BASE CAPSULE / ORAL RLD 2023-06-20
Orange Book patents# Current patent rows page 1 of 1 · 34 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211651-001 10780088 2029-07-27 U-3651 2023-07-19 N211651-001 8012976 2029-07-27 Drug substance, Drug product 2018-11-14 N211651-001 8420650 2029-07-27 Drug substance, Drug product 2018-11-14 N211651-001 9820985 2029-07-27 U-2437 2018-11-14 N211651-001 10189837 2031-10-20 Drug substance, Drug product 2019-02-27 N211651-001 8735392 2031-10-20 Drug substance, Drug product 2018-11-14 N211651-002 8012976 2029-07-27 Drug substance, Drug product 2018-11-14 N211651-002 8420650 2029-07-27 Drug substance, Drug product 2018-11-14 N211651-002 9820985 2029-07-27 U-2437 2018-11-14 N211651-002 10189837 2031-10-20 Drug substance, Drug product 2019-02-27 N211651-002 8735392 2031-10-20 Drug substance, Drug product 2018-11-14 N211651-003 10780088 2029-07-27 U-3651 2023-07-19 N211651-003 8012976 2029-07-27 Drug substance, Drug product 2021-10-19 N211651-003 8420650 2029-07-27 Drug substance, Drug product 2021-10-19 N211651-003 9820985 2029-07-27 U-2437 2021-10-19 N211651-003 10189837 2031-10-20 Drug substance, Drug product 2021-10-19 N211651-003 8735392 2031-10-20 Drug substance, Drug product 2021-10-19 N211651-004 8012976 2029-07-27 Drug substance, Drug product 2021-10-19 N211651-004 8420650 2029-07-27 Drug substance, Drug product 2021-10-19 N211651-004 9820985 2029-07-27 U-2437 2021-10-19 N211651-004 10189837 2031-10-20 Drug substance, Drug product 2021-10-19 N211651-004 8735392 2031-10-20 Drug substance, Drug product 2021-10-19 N211651-005 10780088 2029-07-27 U-3651 2023-07-19 N211651-005 8012976 2029-07-27 Drug substance, Drug product 2023-07-19 N211651-005 8420650 2029-07-27 Drug substance, Drug product 2023-07-19 N211651-005 9820985 2029-07-27 U-2437 2023-07-19 N211651-005 10189837 2031-10-20 Drug substance, Drug product 2023-07-19 N211651-005 8735392 2031-10-20 Drug substance, Drug product 2023-07-19 N211651-006 10780088 2029-07-27 U-3651 2023-07-19 N211651-006 8012976 2029-07-27 Drug substance, Drug product 2023-07-19 N211651-006 8420650 2029-07-27 Drug substance, Drug product 2023-07-19 N211651-006 9820985 2029-07-27 U-2437 2023-07-19 N211651-006 10189837 2031-10-20 Drug substance, Drug product 2023-07-19 N211651-006 8735392 2031-10-20 Drug substance, Drug product 2023-07-19
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N211651-001 I-920 2026-06-20 N211651-003 I-920 2026-06-20 N211651-005 I-920 2026-06-20
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.
Product history page 1 of 5 · 188 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N211651-001 TALZENNA EQ 0.25MG BASE CAPSULE / ORAL RLD 2018-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-002 TALZENNA EQ 1MG BASE CAPSULE / ORAL RLD 2018-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-003 TALZENNA EQ 0.5MG BASE CAPSULE / ORAL RLD 2021-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-004 TALZENNA EQ 0.75MG BASE CAPSULE / ORAL RLD 2021-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-005 TALZENNA EQ 0.1MG BASE CAPSULE / ORAL RLD 2023-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-006 TALZENNA EQ 0.35MG BASE CAPSULE / ORAL RLD 2023-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211651-001 TALZENNA EQ 0.25MG BASE CAPSULE / ORAL RLD 2018-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211651-002 TALZENNA EQ 1MG BASE CAPSULE / ORAL RLD 2018-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211651-003 TALZENNA EQ 0.5MG BASE CAPSULE / ORAL RLD 2021-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211651-004 TALZENNA EQ 0.75MG BASE CAPSULE / ORAL RLD 2021-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211651-005 TALZENNA EQ 0.1MG BASE CAPSULE / ORAL RLD 2023-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211651-006 TALZENNA EQ 0.35MG BASE CAPSULE / ORAL RLD 2023-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211651-001 TALZENNA EQ 0.25MG BASE CAPSULE / ORAL RLD 2018-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211651-002 TALZENNA EQ 1MG BASE CAPSULE / ORAL RLD 2018-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211651-003 TALZENNA EQ 0.5MG BASE CAPSULE / ORAL RLD 2021-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211651-004 TALZENNA EQ 0.75MG BASE CAPSULE / ORAL RLD 2021-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211651-005 TALZENNA EQ 0.1MG BASE CAPSULE / ORAL RLD 2023-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211651-006 TALZENNA EQ 0.35MG BASE CAPSULE / ORAL RLD 2023-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211651-001 TALZENNA EQ 0.25MG BASE CAPSULE / ORAL RLD 2018-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211651-002 TALZENNA EQ 1MG BASE CAPSULE / ORAL RLD 2018-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211651-003 TALZENNA EQ 0.5MG BASE CAPSULE / ORAL RLD 2021-09-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211651-004 TALZENNA EQ 0.75MG BASE CAPSULE / ORAL RLD 2021-09-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211651-005 TALZENNA EQ 0.1MG BASE CAPSULE / ORAL RLD 2023-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211651-006 TALZENNA EQ 0.35MG BASE CAPSULE / ORAL RLD 2023-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211651-001 TALZENNA EQ 0.25MG BASE CAPSULE / ORAL RLD 2018-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211651-002 TALZENNA EQ 1MG BASE CAPSULE / ORAL RLD, RS 2018-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211651-003 TALZENNA EQ 0.5MG BASE CAPSULE / ORAL RLD 2021-09-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211651-004 TALZENNA EQ 0.75MG BASE CAPSULE / ORAL RLD 2021-09-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211651-005 TALZENNA EQ 0.1MG BASE CAPSULE / ORAL RLD 2023-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211651-006 TALZENNA EQ 0.35MG BASE CAPSULE / ORAL RLD 2023-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211651-001 TALZENNA EQ 0.25MG BASE CAPSULE / ORAL RLD 2018-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211651-002 TALZENNA EQ 1MG BASE CAPSULE / ORAL RLD, RS 2018-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211651-003 TALZENNA EQ 0.5MG BASE CAPSULE / ORAL RLD 2021-09-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211651-004 TALZENNA EQ 0.75MG BASE CAPSULE / ORAL RLD 2021-09-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211651-005 TALZENNA EQ 0.1MG BASE CAPSULE / ORAL RLD 2023-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211651-006 TALZENNA EQ 0.35MG BASE CAPSULE / ORAL RLD 2023-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211651-001 TALZENNA EQ 0.25MG BASE CAPSULE / ORAL RLD 2018-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211651-002 TALZENNA EQ 1MG BASE CAPSULE / ORAL RLD, RS 2018-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211651-003 TALZENNA EQ 0.5MG BASE CAPSULE / ORAL RLD 2021-09-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211651-004 TALZENNA EQ 0.75MG BASE CAPSULE / ORAL RLD 2021-09-20 2680178bc6a6…
Observed Orange Book patent history# Patent history page 1 of 26 · 1,020 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N211651-001 10780088 2029-07-27 U-3651 2023-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-001 8012976 2029-07-27 Drug substance, Drug product 2018-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-001 8420650 2029-07-27 Drug substance, Drug product 2018-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-001 9820985 2029-07-27 U-2437 2018-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-001 10189837 2031-10-20 Drug substance, Drug product 2019-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-001 8735392 2031-10-20 Drug substance, Drug product 2018-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-002 8012976 2029-07-27 Drug substance, Drug product 2018-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-002 8420650 2029-07-27 Drug substance, Drug product 2018-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-002 9820985 2029-07-27 U-2437 2018-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-002 10189837 2031-10-20 Drug substance, Drug product 2019-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-002 8735392 2031-10-20 Drug substance, Drug product 2018-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-003 10780088 2029-07-27 U-3651 2023-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-003 8012976 2029-07-27 Drug substance, Drug product 2021-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-003 8420650 2029-07-27 Drug substance, Drug product 2021-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-003 9820985 2029-07-27 U-2437 2021-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-003 10189837 2031-10-20 Drug substance, Drug product 2021-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-003 8735392 2031-10-20 Drug substance, Drug product 2021-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-004 8012976 2029-07-27 Drug substance, Drug product 2021-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-004 8420650 2029-07-27 Drug substance, Drug product 2021-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-004 9820985 2029-07-27 U-2437 2021-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-004 10189837 2031-10-20 Drug substance, Drug product 2021-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-004 8735392 2031-10-20 Drug substance, Drug product 2021-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-005 10780088 2029-07-27 U-3651 2023-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-005 8012976 2029-07-27 Drug substance, Drug product 2023-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-005 8420650 2029-07-27 Drug substance, Drug product 2023-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-005 9820985 2029-07-27 U-2437 2023-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-005 10189837 2031-10-20 Drug substance, Drug product 2023-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-005 8735392 2031-10-20 Drug substance, Drug product 2023-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-006 10780088 2029-07-27 U-3651 2023-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-006 8012976 2029-07-27 Drug substance, Drug product 2023-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-006 8420650 2029-07-27 Drug substance, Drug product 2023-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-006 9820985 2029-07-27 U-2437 2023-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-006 10189837 2031-10-20 Drug substance, Drug product 2023-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211651-006 8735392 2031-10-20 Drug substance, Drug product 2023-07-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211651-001 10780088 2029-07-27 U-3651 2023-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211651-001 8420650 2029-07-27 Drug substance, Drug product 2018-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211651-001 9820985 2029-07-27 U-2437 2018-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211651-001 8012976 2029-10-19 Drug substance, Drug product 2018-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211651-001 10189837 2031-10-20 Drug substance, Drug product 2019-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211651-001 8735392 2031-10-20 Drug substance, Drug product 2018-11-14 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 144 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Talzenna Active Ingredients# Ingredient, Strength table Ingredient Strength TALAZOPARIB TOSYLATE .5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 02WK9U5NZC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 12 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2099946 Internal RxNorm lookup 2099952 Internal RxNorm lookup 2099954 Internal RxNorm lookup 2099956 Internal RxNorm lookup 2591510 Internal RxNorm lookup 2591512 Internal RxNorm lookup 2591520 Internal RxNorm lookup 2591521 Internal RxNorm lookup 2639960 Internal RxNorm lookup 2639962 Internal RxNorm lookup 2639964 Internal RxNorm lookup 2639966 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0069-1501-30 Talzenna 30 in 1 BOTTLE CAPSULE 30 19 0069-1501-30 Talzenna 1 in 1 CARTON CAPSULE 1 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-1501 TALZENNA (TALAZOPARIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC] 17 Current NDC, Legacy NDC, 2 package rows 20250406_f2423edd-6d24-495c-aec1-c2f457f08d9a.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0069-1501-30 00069150130 1 BOTTLE in 1 CARTON (0069-1501-30) / 30 CAPSULE in 1 BOTTLE 1 bottle 2022-01-31 2027-03-31 No No Current