Talzenna

Product NDC: 0069-1751
11-digit product format: 000691751
Labeler code: 0069
Product ID: 0069-1751_b09c6407-5885-4f14-82cb-447b36ad8824
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: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0069-1751		D	Discontinued by firm		2026-09-09
excluded package	package	0069-1751	0069-1751-30	D	Discontinued by firm		2026-09-09

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

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

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	0069-1751		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0069-1751	0069-1751-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	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 · 194 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211651-001	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-002	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-003	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-004	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-005	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-006	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 27 · 1,054 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211651-001	10780088	2029-07-27	U-3651		2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-001	8012976	2029-07-27		Drug substance, Drug product	2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-001	8420650	2029-07-27		Drug substance, Drug product	2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-001	9820985	2029-07-27	U-2437		2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-001	10189837	2031-10-20		Drug substance, Drug product	2019-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-001	8735392	2031-10-20		Drug substance, Drug product	2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-002	8012976	2029-07-27		Drug substance, Drug product	2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-002	8420650	2029-07-27		Drug substance, Drug product	2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-002	9820985	2029-07-27	U-2437		2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-002	10189837	2031-10-20		Drug substance, Drug product	2019-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-002	8735392	2031-10-20		Drug substance, Drug product	2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-003	10780088	2029-07-27	U-3651		2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-003	8012976	2029-07-27		Drug substance, Drug product	2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-003	8420650	2029-07-27		Drug substance, Drug product	2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-003	9820985	2029-07-27	U-2437		2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-003	10189837	2031-10-20		Drug substance, Drug product	2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-003	8735392	2031-10-20		Drug substance, Drug product	2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-004	8012976	2029-07-27		Drug substance, Drug product	2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-004	8420650	2029-07-27		Drug substance, Drug product	2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-004	9820985	2029-07-27	U-2437		2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-004	10189837	2031-10-20		Drug substance, Drug product	2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-004	8735392	2031-10-20		Drug substance, Drug product	2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-005	10780088	2029-07-27	U-3651		2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-005	8012976	2029-07-27		Drug substance, Drug product	2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-005	8420650	2029-07-27		Drug substance, Drug product	2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-005	9820985	2029-07-27	U-2437		2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-005	10189837	2031-10-20		Drug substance, Drug product	2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-005	8735392	2031-10-20		Drug substance, Drug product	2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-006	10780088	2029-07-27	U-3651		2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-006	8012976	2029-07-27		Drug substance, Drug product	2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-006	8420650	2029-07-27		Drug substance, Drug product	2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-006	9820985	2029-07-27	U-2437		2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-006	10189837	2031-10-20		Drug substance, Drug product	2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-006	8735392	2031-10-20		Drug substance, Drug product	2023-07-19	`caaa826d4ba7…`
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…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 147 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N211651-001	I-920	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-003	I-920	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-005	I-920	2026-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211651-001	I-920	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-003	I-920	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-005	I-920	2026-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-001	I-920	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-003	I-920	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-005	I-920	2026-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211651-001	I-920	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211651-003	I-920	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211651-005	I-920	2026-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211651-001	I-920	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211651-003	I-920	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211651-005	I-920	2026-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211651-001	I-920	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211651-003	I-920	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211651-005	I-920	2026-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211651-001	I-920	2026-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211651-003	I-920	2026-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211651-005	I-920	2026-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211651-001	I-920	2026-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211651-003	I-920	2026-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211651-005	I-920	2026-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211651-001	I-920	2026-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211651-003	I-920	2026-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211651-005	I-920	2026-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211651-001	I-920	2026-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211651-003	I-920	2026-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211651-005	I-920	2026-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211651-001	I-920	2026-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211651-003	I-920	2026-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211651-005	I-920	2026-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211651-001	I-920	2026-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211651-003	I-920	2026-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211651-005	I-920	2026-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211651-001	I-920	2026-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211651-003	I-920	2026-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211651-005	I-920	2026-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211651-001	I-920	2026-06-20	`1e350fbaab3a…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0f22ae3e-e8f8-4cc5-86db-e9dcae189816	Product name	1	20250123
ee7ffa9d-6478-411c-a335-77574996aac2	Product name	1	20190125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0069-1751-30	Talzenna	30 in 1 BOTTLE	CAPSULE	30		19
0069-1751-30	Talzenna	1 in 1 CARTON	CAPSULE	1		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0069-1751-30	EA - Each	0069-1751	59431b52-017c-4cf3-a9d6-4d7517149de6	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0069-1751	TALZENNA (TALAZOPARIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]	17	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Talzenna	TALAZOPARIB	U.S. Pharmaceuticals	13839d4f-6acf-4ffb-a128-79df59319273	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211651 application number: NDA211651
Talzenna	TALAZOPARIB	Pfizer Laboratories Div Pfizer Inc	f2423edd-6d24-495c-aec1-c2f457f08d9a	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211651 application number: NDA211651 ndc (product): 0069-1751

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
02WK9U5NZC	TALAZOPARIB TOSYLATE	1373431-65-2	TALAZOPARIB TOSYLATE
9QHX048FRV	TALAZOPARIB	1207456-01-6	talazoparib

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2639960	talazoparib 0.1 MG Oral Capsule	PSN	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2099946	talazoparib 0.25 MG Oral Capsule	PSN	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2639964	talazoparib 0.35 MG Oral Capsule	PSN	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2591510	talazoparib 0.5 MG Oral Capsule	PSN	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2591520	talazoparib 0.75 MG Oral Capsule	PSN	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2099954	talazoparib 1 MG Oral Capsule	PSN	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2639962	Talzenna 0.1 MG Oral Capsule	PSN	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2099952	Talzenna 0.25 MG Oral Capsule	PSN	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2639966	Talzenna 0.35 MG Oral Capsule	PSN	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2591512	Talzenna 0.5 MG Oral Capsule	PSN	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2591521	Talzenna 0.75 MG Oral Capsule	PSN	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2099956	Talzenna 1 MG Oral Capsule	PSN	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2639962	talazoparib 0.1 MG Oral Capsule [Talzenna]	SBD	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2099952	talazoparib 0.25 MG Oral Capsule [Talzenna]	SBD	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2639966	talazoparib 0.35 MG Oral Capsule [Talzenna]	SBD	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2591512	talazoparib 0.5 MG Oral Capsule [Talzenna]	SBD	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2591521	talazoparib 0.75 MG Oral Capsule [Talzenna]	SBD	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2099956	talazoparib 1 MG Oral Capsule [Talzenna]	SBD	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2639960	talazoparib 0.1 MG Oral Capsule	SCD	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2099946	talazoparib 0.25 MG Oral Capsule	SCD	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2639964	talazoparib 0.35 MG Oral Capsule	SCD	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2591510	talazoparib 0.5 MG Oral Capsule	SCD	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2591520	talazoparib 0.75 MG Oral Capsule	SCD	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2099954	talazoparib 1 MG Oral Capsule	SCD	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2639960	talazoparib 0.1 MG (as talazoparib tosylate 0.145 MG) Oral Capsule	SY	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2099946	talazoparib 0.25 MG (as talazoparib tosylate 0.363 MG) Oral Capsule	SY	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2099952	talazoparib 0.25 MG (as talazoparib tosylate 0.363 MG) Oral Capsule [Talzenna]	SY	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2639964	talazoparib 0.35 MG (as talazoparib tosylate 0.509 MG) Oral Capsule	SY	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2591510	talazoparib 0.5 MG (as talazoparib tosylate 0.727 MG) Oral Capsule	SY	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2591520	talazoparib 0.75 MG (as talazoparib tosylate 1.09 MG) Oral Capsule	SY	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2099954	talazoparib 1 MG (as talazoparib tosylate 1.453 MG) Oral Capsule	SY	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2639962	Talzenna 0.1 MG (as talazoparib tosylate 0.145 MG) Oral Capsule	SY	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2099952	Talzenna 0.25 MG Oral Capsule	SY	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2639966	Talzenna 0.35 MG (as talazoparib tosylate 0.509 MG) Oral Capsule	SY	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2591512	Talzenna 0.5 MG Oral Capsule	SY	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2591521	Talzenna 0.75 MG Oral Capsule	SY	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2099956	Talzenna 1 MG (as talazoparib tosylate 1.453 MG) Oral Capsule	SY	f2423edd-6d24-495c-aec1-c2f457f08d9a	19
2099956	Talzenna 1 MG Oral Capsule	SY	f2423edd-6d24-495c-aec1-c2f457f08d9a	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0069-1751-30	00069175130	1 BOTTLE in 1 CARTON (0069-1751-30) > 30 CAPSULE in 1 BOTTLE	1 bottle	2022-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Talzenna	Pfizer Laboratories Div Pfizer Inc \| Viatris Pharmaceuticals LLC \| Pharmacia & Upjohn Company LLC	2025-12-18	HUMAN PRESCRIPTION DRUG LABEL	19